Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Patients with prostate cancer enrolled i active surveillance protocol using PSA, digital rectal examination and conventional TRUS-biopsies

Patients with newly diagnosed prostate cancer enrolled in active surveillance following standard protocol including PSA, DRE and TRUS biopsies and intervention with multiparametric MRI + additional biopsies if suspicious lesions are found

multiparametric MRI Diagnostics

Lars Boesen, MD, PhD

To investigate whether multiparametric MRI (mp-MRI) in patients with low-risk prostate cancer can improve the selection of patients suitable for Active Surveillance and have a relevance in the ongoing monitoring

Men with localized prostate cancer (PCa) with small tumor burden may be followed on active surveillance (AS) rather than active treatment. AS is an attempt to avoid over-treatment of PCa, which is estimated to be insignificant at the time of diagnosis, and therefore unlikely to affect patient morbidity and mortality. AS include close monitoring with PSA measurement (blood test), digital rectal exploration (DRE) and trans-rectal ultrasound-guided prostate biopsy (TRUS-bx) at regular intervals, so that active treatment can be initiated if the cancer becomes more aggressive. It is crucial that patients undergoing AS are staged correctly, to avoid underestimating more aggressive disease and patients mistakenly are enrolled into AS instead of active treatment.

Previously, a PhD study conducted at Herlev Hospital revealed that multiparametric MRI (mp-MRI) of the prostate can improve the detection and staging of PCa and may add additional information about tumor aggressiveness compared to the traditional methods DRE and TRUS-bx. Mp-MRI at the inclusion of AS may detect missed significant tumors and potential areas of higher aggressiveness than detected by the traditional biopsies. Additional targeted biopsies from these suspicious areas can then be performed with a re-evaluation of the treatment plan, if more advanced disease is identified. Conversely, mp-MRI has a high negative predicted value for significant disease and can be used to rule out significant PCa, reassuring patients and physicians to go on with AS. Mp-MRI has been used at the Urology Department, Herlev Hospital, since 2013 in the diagnosis of PCa and in the evaluation of patients undergoing AS. A retrospective study have show that mp-MRi improve the detection of missed significant PCa.

The main objective of this study is now to prospectively investigate, whether mp-MRI can improve the selection of patients suitable for Active Surveillance and have a relevance in the ongoing monitoring.

Multiparametric MRI in Men With Prostate Cancer Enrolled in Active Surveillance

Patients enrolled in active surveillance will progress to active treatment if mp-MRI show previously undetected suspicious areas of significant disease. Significant cancer (measured by Gleason score and cancer core involvement on biopsies) will be confirmed by repeat biopsies of the suspicious areas. The decision to progress to active treatment is based on decision from the treating urologist.

Herlev Hospital

Primary investigator, MD, PhD

Skin and Connective Tissue Diseases

Breast Neoplasms

Breast Diseases

Skin Diseases

Prognostic assessment after preoperative systemic therapy (PST) plays a vital role in breast cancer patients. The clinical-pathologic staging system incorporating estrogen receptor (ER)-negative disease and nuclear grade 3 tumor pathology (CPS+EG staging system) can effectively predict prognosis after PST. The Neo-Bioscore has been developed by the incorporation of the human epidermal growth factor receptor 2 (HER2) status into the CPS+EG staging system. But in a real world in China, the both staging systems had limits because of trastuzumab administration varied a lot in China from the United States. This retrospective study will validate CPS+EG and Neo-Bioscore system and explored a modified Neo-Bioscore system in multiple centers.

Validation of the CPS+EG, Neo-Bioscore and Modified Neo-Bioscore Staging Systems After PST of BC in China

Validation of CPS+EG, Neo-Bioscore and Modified Neo-Bioscore Staging System After Preoperative Systemic Therapy of Breast Cancer in Multi-center in China

DSS will be calculated from the time of diagnosis to death resulting from breast cancer. Patients still alive at the time of the analysis will be censored using the date they were last known to be alive.

DFS, defined as the time from the time of post-PST breast cancer surgery to local recurrence following mastectomy, local recurrence in the ipsilateral breast following lumpectomy (invasive or non-invasive), regional recurrence, distant metastasis, contralateral breast cancer (invasive or non-invasive), second primary cancer (other than squamous or basal cell carcinoma of the skin, melanoma in situ, carcinoma in situ of the cervix, colorectal carcinoma in situ, or lobular carcinoma in situ of the breast), or death from any cause prior to recurrence or second primary cancer. Patients who have not had any such event at the time of data analysis will be censored at the last date they were known to be event-free.

OS will be measured as the time from the date of diagnosis to the date of death. Patients still alive at the time of the analysis will be censored using the date they were last known to be alive.

Peking University First Hospital

Associate Chief Physician of Breast Disease Center, Associate Professor, M.D.

Mouth and Tooth Diseases

Ear, Nose, and Throat Diseases

Rare Diseases

Nasopharyngeal Carcinoma

Carcinoma

Nasopharyngeal Neoplasms

Neoplasms, Glandular and Epithelial

Neoplasms by Histologic Type

Pharyngeal Neoplasms

Otorhinolaryngologic Neoplasms

Head and Neck Neoplasms

Nasopharyngeal Diseases

Pharyngeal Diseases

Stomatognathic Diseases

Otorhinolaryngologic Diseases

Anti-Inflammatory Agents

Antirheumatic Agents

Analgesics

All Drugs and Chemicals

Chrysarobin

Each of the eight independent prognostic factors (age, sex, T and N stages, hemoglobin during radiotherapy, variation tendency of Hb, neutrophil-lymphocyte ratio before radiotherapy and platelet during radiotherapy) was assigned a number of points proportional to its regression coefficient to calculate prognostic index (PI), which ranged from 1 to 17. Patients with PI equal to 1-4 called the low risk group.

Each of the eight independent prognostic factors (age, sex, T and N stages, hemoglobin during radiotherapy, variation tendency of Hemoglobin, neutrophil-lymphocyte ratio before radiotherapy and platelet during radiotherapy) was assigned a number of points proportional to its regression coefficient to calculate prognostic index (PI), which ranged from 1 to 17. Patients with PI equal to 5-11 called the intermediate risk group.

Each of the eight independent prognostic factors (age, sex, T and N stages, hemoglobin during radiotherapy, variation tendency of Hemoglobin, neutrophil-lymphocyte ratio before radiotherapy and platelet during radiotherapy) was assigned a number of points proportional to its regression coefficient to calculate prognostic index (PI), which ranged from 1 to 17. Patients with PI equal to 12-17 called the high risk group.

Yun-fei Xia, MD

Hui Chang, MD

RATIONALE

1. In patients with nasopharyngeal carcinoma, there is sometimes a discrepancy between actual clinical outcome and TNM stages because it is an anatomy-based system in which functional factors are not concerned.
2. Hemoglobin, neutrophil to lymphocyte ratio and platelet count were proved to improve prognosis prediction of TNM staging system in our previous retrospective study.

PURPOSE To validate that the prognostic index based on complete blood count and TNM system had higher prediction efficiency on survival in nasopharyngeal carcinoma than TNM system alone.

Totally 720 patients with non-metastatic nasopharyngeal carcinoma will be include and will be divided into 3 groups (Low Risk, Intermediate Risk and High Risk Groups) according to their prognostic index, which is on basis of blood cell count indexes and TNM stage. The 3 groups of patients will undergo a radical radiotherapy or chemoradiotherapy and be followed until death or the end of the study. Comparison on survivals of the 3 groups will be made to validate the accuracy of the prognostic index. And comparison on prediction efficacy between prognostic index and TNM staging system will be made.

Hemoglobin, Neutrophil to Lymphocyte Ratio and Platelet Count Improve Prognosis Prediction in Nasopharyngeal Carcinoma

Hemoglobin, Neutrophil to Lymphocyte Ratio and Platelet Count Improve Prognosis Prediction of TNM Staging System in Nasopharyngeal Carcinoma: A Prospective Multi-institutional Observation Study

The period until any event (death, local recurrence or distant metastasis) is detected.

The period until local recurrence or distant metastasis is detected.

The period until local recurrence is detected.

The period until distant metastasis is detected.

Sun Yat-sen University

Department of Radiation Oncology, Sun Yat-sen University Cancer Center

To investigate whether multiparametric MRI (mp-MRI) in patients with low-risk prostate cancer can improve the selection of patients suitable for Active Surveillance and have a relevance in the ongoing monitoring.

Men with localized prostate cancer (PCa) with small tumor burden may be followed on active surveillance (AS) rather than active treatment. AS is an attempt to avoid over-treatment of PCa, which is estimated to be insignificant at the time of diagnosis, and therefore unlikely to affect patient morbidity and mortality. AS include close monitoring with PSA measurement (blood test), digital rectal exploration (DRE) and trans-rectal ultrasound-guided prostate biopsy (TRUS-bx) at regular intervals, so that active treatment can be initiated if the cancer becomes more aggressive. It is crucial that patients undergoing AS are staged correctly, to avoid underestimating more aggressive disease and patients mistakenly are enrolled into AS instead of active treatment.

Previously, a PhD study conducted at Herlev Hospital revealed that multiparametric MRI (mp-MRI) of the prostate can improve the detection and staging of PCa and may add additional information about tumor aggressiveness compared to the traditional methods DRE and TRUS-bx. Mp-MRI at the inclusion of AS may detect missed significant tumors and potential areas of higher aggressiveness than detected by the traditional biopsies. Additional targeted biopsies from these suspicious areas can then be performed with a re-evaluation of the treatment plan, if more advanced disease is identified. Conversely, mp-MRI has a high negative predicted value for significant disease and can be used to rule out significant PCa, reassuring patients and physicians to go on with AS. Mp-MRI has been used at the Urology Department, Herlev Hospital, since 2013 in the diagnosis of PCa and in the evaluation of patients undergoing AS. The main objective of this study is to retrospectively investigate, whether mp-MRI can improve the selection of patients suitable for Active Surveillance and have a relevance in the ongoing monitoring.

Multiparametric MRI in Men With Prostate Cancer Undergoing Active Surveillance

Observe changes in the detection-rate of significant prostate cancer using mp-MRI and mp-MRI targeted biopsies in men with newly diagnosed low risk prostate cancer enrolled i active surveillance. Mp-MRI is performed approximately 2½ month after the initial prostate biopsy.

MD, PhD

Urinary Bladder Neoplasms

Urologic Neoplasms

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Fluorodeoxyglucose F18

suspected MIBC participants receive FAPI PET/MRI examination after entering the group.

suspected MIBC participants receive FDG PET/MRI examination after entering the group.

suspected MIBC participants receive MRI examination after entering the group.

Patients diagnosed with MIBC receive FAPI PET/MRI examination before and after neoadjuvant therapy.

Patients diagnosed with MIBC receive FDG PET/MRI examination before and after neoadjuvant therapy.

Patients diagnosed with MIBC receive MRI examination before and after neoadjuvant therapy.

FAPI PET/MRI and FDG PET/MRI examination Data acquisition was performed using a GE Healthcare SIGNA PET/MR instrument. Enrolled patients were injected intravenously with 68Ga-FAPI or 18F-FDG tracer and underwent simultaneous PET and MRI scanning approximately 30-60 minutes after intravenous administration of the tracer at a dose of 1.85-3.7 MBq/kg.

MRI examination MRI examination was performed using a Skyra 3.0T MRI scanner from Siemens, Germany, with a 16-channel phased-array surface coil, and the scanning range was from the superior margin of the iliac wing to the inferior margin of the pubic symphysis.

imaging examinations:FAPI PET/MRI, FDG PET/MRI, MRI

Ning Xu, Doctor

Xiao-Dong Li, Master

Xue-Yi Xue, Master

The aim of this trial is to investigate the value of FAPI PET/MRI, FDG PET/MRI and MRI in diagnosing MIBC and predicting the efficacy of neoadjuvant therapy for MIBC patients, so as to guide the clinic to adjust the treatment plan in time and benefit MIBC patients.

The MIBC diagnostic study was a prospective trial. According to the inclusion and exclusion criteria, patients with suspected MIBC were enrolled and underwent FAPI PET/MRI, FDG PET/MRI and MRI examination, and the imaging data and clinical laboratory and pathologic data were collected, and the postoperative pathological results were used as the gold standard to compare the accuracy of FAPI PET/MRI, FDG PET/MRI and MRI in diagnosing MIBC.

The MIBC neoadjuvant therapy efficacy assessment study was a prospective trial. Patients with MIBC were enrolled according to the inclusion and exclusion criteria, the regimen was selected individually according to the patient's condition, and the indicators were followed up until the end of time or the occurrence of an endpoint event to obtain information on survival time. FAPI PET/MRI, FDG PET/MRI and MRI were performed once before the start of neoadjuvant therapy and once after the end of therapy, and after the end of neoadjuvant therapy, patients received transurethral cystectomy of bladder tumors or radical cystectomy according to the efficacy and condition, and the combination of the imaging data and the clinical laboratory and pathological data were used to compare FAPI PET/MRI, FDG PET/ MRI and MRI in the assessment of the efficacy of neoadjuvant therapy in MIBC patients to guide clinical treatment options.

In the MIBC diagnostic study and neoadjuvant efficacy prediction study, each patient underwent FAPIPET/MRI, FDGPET/MRI and MRI examinations, and were grouped and analyzed according to different examination methods.

FAPI and FDG PET/MRI in Diagnosis and Therapy Prediction of Bladder Cancer

Application Research of FAPI Positron Emission Tomography(PET)/MRI, 18F-Fluorodeoxyglucose (FDG) PET/MRI, and MRI in the Diagnosis of Muscular Invasive Bladder Cancer and Evaluation of Neoadjuvant Therapy Efficacy

We have chosen not to share the individual participant data (IPD) from this clinical study due to privacy and confidentiality concerns, as well as potential proprietary interests. Additionally, sharing IPD requires considerable resources for data de-identification and preparation, which may not be feasible within the scope of this study. However, we remain committed to transparency and will provide summary results and findings through appropriate channels, ensuring the dissemination of key insights while safeguarding participant privacy and confidentiality

It is the percentage of patients who will be correctly judged as positive (true positive) if they actually have muscle invasive bladder cancer. The formula is TP/(TP+FN)×100%.TP is true positive and FN is false negative.

the percentage of patients who are not actually suffering from muscle invasive bladder cancer correctly judged as negative (true negative). The formula is TN/(TN+FP)×100%.TN is true negative, FP is false positive.

the ratio of true positives among the positive results obtained by a specific test method. The formula is: PPV=TP/(TP+FP)×100%.

refers to the ratio of true negatives among the negative results obtained by a specific test method. The formula is: NPV=TN/(TN+FN)×100%.

the ratio of the probability that a patient who actually has muscle invasive bladder cancer is judged to be positive to the probability that a patient who actually does not have muscle invasive bladder cancer is judged to be positive. The formula was calculated as +LR = sensitivity/(1-specificity) × 100%.

the ratio of the probability that a patient who actually has muscle invasive bladder cancer is judged negative to the probability that a patient who actually does not have muscle invasive bladder cancer is judged negative. The formula is: -LR=(1-sensitivity)/specificity×100%.

the sum of sensitivity and specificity minus 1. Correct diagnostic index can be used for the comparison of two diagnostic methods, and the ideal correct diagnostic index is 100%. r = (specificity + sensitivity) - 1 = 1 - (false positive rate + false negative rate)

changes in SUVmax, SUVmean, and SUVpeak of the tumor lesion before and after treatment obtained from PET/MRI images.

changes in the ratio of the radioactivity of tumor tissue to the radioactivity of background tissue obtained from PET/MRI images before and after treatment.

In RECIST 1.1 Efficacy assessment criteria for conventional imaging, CR was defined as the disappearance of all target lesions, the absence of new lesions, and the normalization of tumor markers for at least 4 weeks. In PERCIST 1.1 efficacy evaluation criteria for FAPI PET/MRI and FDG PET/MRI, CR refers to the complete disappearance of tracer uptake.

In RECIST 1.1 Efficacy assessment criteria for conventional imaging, PR was defined as a decrease of ≥30% in the sum of the largest diameters of target lesions for at least 4 weeks. In PERCIST 1.1 efficacy evaluation criteria for FAPI PET/MRI and FDG PET/MRI, PR refers to a decrease of \>30% in the peak SUV.

In RECIST 1.1 Efficacy assessment criteria for conventional imaging, SD was defined as a decrease in the sum of the largest diameters of the target lesions that did not reach PR or an increase in the size of the largest diameters of target lesions that did not reach PD. In PERCIST 1.1 efficacy evaluation criteria for FAPI PET/MRI and FDG PET/MRI, SD refers to a decrease of \>30% in the peak SUV.

In RECIST 1.1 Efficacy assessment criteria for conventional imaging, PD was defined as an increase in the sum of the largest diameters of the target lesions by at least ≥20% or the emergence of new lesions. In PERCIST 1.1 efficacy evaluation criteria for FAPI PET/MRI and FDG PET/MRI, PD refers to an increase of \>30% in the peak SUL or the appearance of new lesions.

For participants receiving FAPI PET/MRI and FDG PET/MRI, according to EORTC efficacy assessment criteria, CMR refers to the complete disappearance of tracer uptake.

For participants receiving FAPI PET/MRI and FDG PET/MRI, according to EORTC efficacy assessment criteria, PMR refers to a reduction in SUV of ≥15%-25% after one cycle of treatment and a reduction in SUV of \>25% after greater than one cycle of treatment.

For participants receiving FAPI PET/MRI and FDG PET/MRI, according to EORTC efficacy assessment criteria, SMD refers to an increase in SUV of \<25% or a decrease of \<15%, and tumor no significant increase in the extent of uptake (\>20% increase in maximum diameter)

For participants receiving FAPI PET/MRI and FDG PET/MRI, according to EORTC efficacy assessment criteria, PMD refers to an increase in SUV value of \>25% and a significant increase in the extent of tumor uptake (increase in the largest diameter of \>20%), or the appearance of new foci.

According to pathological efficacy assessment criteria, Pathological Complete Remission(pCR) refers to no detectable tumor (pT0) or residual cancer confined to the original site (pTis) after treatment. According to pathological efficacy assessment criteria, A decrease in tumor stage from cT2 (Muscle-Invasive Bladder Cancer - MIBC) to non-muscle-invasive bladder cancer (NMIBC), including stages pT0, pTis, pTa, and pT1, indicates a treatment-sensitive tumor and is considered a good pathologic response. Conversely, if the tumor stage remains the same or increases, it is considered a poor pathologic response.

the duration from the time a patient receives systemic therapy to the time of death from any cause.

the duration from the start of treatment to the occurrence of imaging progression or death due to any cause (whichever occurs first). Conventional imaging (RECIST 1.1 criteria), and FAPI PET/MRI (PERCIST 1.0 criteria) were used to assess the imaging progression of patients after receiving treatment, respectively.

usually includes patient cases with CR+PR. Among them, conventional imaging was used to assess the proportion of patients meeting the criteria for CR or PR using the RECIST 1.1 criteria; FAPI PET/MRI was used to assess the proportion of patients meeting the criteria for CR or PR using the PERCIST 1.0 criteria;

usually includes the proportion of patients with CR+PR+SD. Among them, conventional imaging uses RECIST 1.1 criteria to assess the proportion of patients meeting the criteria of CR or PR or SD; FAPI PET/MRI uses PERCIST 1.0 criteria to assess the proportion of patients meeting the criteria of CR or PR or SD.

First Affiliated Hospital of Fujian Medical University

Deputy Director of Department

Patrick Veit-Haibach, MD

Diagnostic accuracy of PET/magnetic resonance and PET/CT will be compared concerning primary tumor, regional nodes, metastasis (TNM) staging and therapeutic influence. Workflow scenarios will be evaluated to create imaging protocols which are time efficient and diagnostically accurate.

Diagnostic Comparison of PET-magnetic Resonance and PET-CT in Patients With Oncologic Diseases

Diagnostic Comparison and Workflow Evaluation of Whole Body PET-magnetic Resonance and PET-CT With and Without Contrast Media in Patients With Oncologic Diseases

University of Zurich

Behaviors and Mental Disorders

Nervous System Diseases

Aggression

Dementia

Aberrant Motor Behavior in Dementia

Behavioral Symptoms

PET-MR 18f-FACBC

histopathological classification of co-located dissected lymph nodes

histology (gold standard)

Anders Angelsen, prof

Prostate cancer is the most frequent cancer in Norwegian men. For optimal treatment, accurate staging of the disease at the time point of diagnosis is important. The objective of this study is to evaluate the diagnostic potential of a combined PET/MR examination for risk assessment and detection of lymph node metastases. The overall aim of the project is to improve the investigators ability to provide individually tailored treatment to prostate cancer patients.

The study will include 32 men with high-risk prostate cancer, who are eligible for radical prostatectomy. Informed consent is a requirement for inclusion in the study.

Pre-operative PET-MR of High Risk Prostate Cancer Patients for Assessment of Cancer Aggressiveness and Lymph Node Status

Findings on 18FACBC PET/MR images will be compared to histopathology, which is considered the gold standard for evaluation of pelvic lymph node metastases

Norwegian University of Science and Technology

Norwegian Cancer Society

St. Olavs Hospital

Danish men with localized prostate cancer

A mMRI is performed before treatment of the patient and is compared to the standard diagnostic tools for evaluating the clinical stage and diagnose of prostate cancer

Multiparametric magnetic resonance imaging (mMRI)

Lars P. Boesen, M.D.

Clinical staging of prostate cancer in Denmark is determined solely by digital rectal examination and sometimes by TRUS, even though the investigators know these examinations are inaccurate and have limitations. Since the majority of men diagnosed with prostate cancer will die with their disease and not of their disease, and the different treatment-options may imply greater side effects, it is important to improve the diagnostic localization and staging of the tumour for optimal clinical management and therapy selection.

The development of modern multiparametric-high-field-magnetic-imaging (mMRI) offers new possibilities and approaches in detection, localization and staging of prostate cancer due to its high resolution and soft-tissue contrast. mMRI can provide information about the morphological, metabolic and cellular changes and characterize tissue- and tumour- vascularity and correlate it with tumour aggressiveness. This helps to locate and stage a possible tumour and to guide targeted-biopsies towards disease-suspicious areas. Internationally published data support the rapidly growing use of multiparametric MRI, as being the most sensitive and specific imaging tool for prostate cancer patients.

While mMRI internationally is a well recognized and accepted method for detection, localization and staging of prostate cancer, the use of mMRI in the diagnosis of PCa in Denmark has never been applied. Therefore, this project is carried out in order to evaluate the use of modern mMRI in the diagnosis of prostate cancer in a Danish setup.

Prostate cancer (PCa) is now the most frequently diagnosed male malignant disease in Denmark with more than 4000 new cases each year. PCa is the second leading cause of cancer related mortality in the western world. During their lifetime, one in six men will be clinically diagnosed with Prostate cancer and approximately one out of thirty will die of the disease. We know from autopsies that more than half of the male-population above the age of 60 is found to have histological cancer-changes. Therefore, the majority of men with histological proven cancer-changes will never develop a clinical disease that would affect their morbidity and mortality.

An elevated PSA (blood sample) and/or an abnormal rectal examination are indications of PCa. The diagnosis is made by trans-rectal-ultrasound guided biopsies (TRUS-biopsies) followed by histological examination. Each biopsy-session includes 10 to 12 biopsy-cores taken from standard locations throughout the prostate. Since over 40 % of the cancers are isoechoic on ultrasound and cannot be seen, there is a high risk that the tumour is either missed or that the most aggressive part of the tumour is not biopsied.

If you find a prostate cancer, it is important to know if the cancer is localized within the prostate or if it grows outside of the capsule. This is called staging and is essential in determine the best treatment-strategy and the patient's prognosis. In Denmark, staging is determined by digital rectal examination and sometimes by TRUS, even though we know these examinations are inaccurate and have limitations. It is important to improve the diagnostic localization and staging of the tumour for optimal clinical management and therapy selection.

The development of modern multiparametric-high-field-magnetic-imaging (mMRI) offers new possibilities and approaches in detection, localization and staging of prostate cancer due to its high resolution and soft-tissue contrast. mMRI can provide information about the morphological, metabolic and cellular changes and characterize tissue- and tumour- vascularity and correlate it with tumour aggressiveness. This helps to locate and stage a possible tumour and to guide targeted-biopsies towards disease-suspicious areas. Internationally published data support the rapidly growing use of multiparametric MRI, as being the most sensitive and specific imaging tool for prostate cancer patients.

The primary objective of this project is to investigate whether the use of modern MRI in Denmark can:

* Improve the diagnosis of Danish men suspected of prostate cancer and
* Improve the diagnosis and treatment planning of Danish men with biopsy-proven prostate cancer.

The secondary goal is to gain experience in the use of modern MRI in Denmark to evaluate prostatic tumors. This study forms the basis for investigating whether modern MRI should be used as an adjunct diagnostic tool for selected patients in the diagnosis of prostate cancer.

The project contains three separate studies evaluating the adjunct diagnostic value of mMRI to the conventional standard diagnostic evaluation and treatment.

The three studies:

* Study 1 is offered to patients with newly diagnosed localized non-metastatic prostate cancer and is comparing mMRI to TRUS and DRE in clinical classification of the cancer.
* Study 2 is offered to patients with newly diagnosed localized non-metastatic prostate cancer who underwent Brachytherapy and is comparing mMRI to CT-scan performed 4 weeks after surgery in the evaluation of postoperative dosimetry (treatment effect).
* Study 3 is offered to patients scheduled for re-biopsy due to continuing suspicion of prostate cancer after standard TRUS-guided biopsies with negative findings to see if multiparametric MRI can detect prostate cancer invisible on transrectal ultrasound; in order to improve detection rate.

Evaluation of Modern MRI in the Diagnosis of Prostate Cancer in a Danish Setup

Study 1: Change in clinical T-stage (TNM-classification) at baseline compared to the patological T-stage after curative treatment approx. 4 weeks later.

Study 2: Change in prostatic volumen expressed in milliliter(ml) on CT and MRI 4 weeks after brachytherapy-operation compared to the prostatic volumen on TRUS at baseline.

Study 3: Change detectionrate of prostatecancer using MRI-targeted biopsies.

This study forms the basis for investigating whether modern MRI should be used as an adjunct diagnostic tool for selected patients in the diagnosis of prostate cancer

Copenhagen University Hospital at Herlev

Symptoms and General Pathology

Recurrence

Disease Attributes

Patients with a biopsy assessing an ipsilateral breast tumor recurrence, and a diagnosis of invasive carcinoma after a previous diagnosis of breast cancer that has been treated by breast conservative surgery at least one year before.

Before the SLNB procedure, each patient will have a lymphoscintigraphy to evaluate axillary and extra axillary lymphatic mapping.

Patients will be operated by breast conservative surgery (BCS) or mastectomy. Each patient will have a second SLND followed by a systematic complete ALND.

Sentinel Lymph-Node (LN) procedure and Axillary LN dissection ; Mastectomy or breast conservative surgery

Sentinel LN in breast cancer recurrence

VIRGINIE BORDES, MD

Sentinel lymph node biopsy (SLNB) has become the standard procedure for staging of patients with clinically node-negative breast cancer.

Breast-conserving surgery (BCS) has also been a standard treatment for patients with early breast cancer. However, approximately 10% of patients with BCS develop ipsilateral breast tumor recurrence (IBTR), and mastectomy or resection of the recurrent tumor is generally performed.

There are no specific guidelines available regarding staging and treatment of the regional lymph nodes. However, the reported risk of axillary lymph node metastasis among patients with local recurrence after breast surgery and a previous negative sentinel node biopsy of 26 % is too high to be ignored.

Moreover, evaluation of the regional lymph node basins might be helpful to decide on the indication for adjuvant radiotherapy and systemic treatment. For these reasons it seems sensible to perform a regional lymph node staging procedure in patients with locally recurrent breast cancer.

In general practice, this would mean that patients with recurrent breast cancer and a previous negative sentinel node biopsy would receive an axillary lymph node dissection (ALND) and that patients with a previous ALND would receive no additional axillary staging.

Lymphatic drainage after previous breast surgery and/or radiotherapy would be altered and it remains questionable whether SLNB at the time of surgery for IBTR (second SLNB) is technically feasible and ALND can safely be omitted.

In this study, investigators propose for all patients the realization of SLNB procedure and systematically ALND whatever the results of SLNB analysis, only on patients previously treated with breast conservative surgery.

The aim of this study is to evaluate on a homogeneous prospective multicentric cohort of patients the feasibility and the accuracy of a second SLNB procedure for IBTR.

FIGARO is a prospective multicentre phase-2 study that aims to evaluate technical feasibility and validity of performing second sentinel lymph node dissection (SLND) in patients with IBTR .

To be included, patients must have a biopsy assessing an ipsilateral breast tumor recurrence, and a diagnosis of invasive carcinoma after a previous diagnosis of breast cancer that has been treated by breast conservative surgery at least one year before (time between the end of the previous radiotherapy and the diagnosis of recurrence).

At time of recurrence, the patients must be evaluated by X-ray mammography and ultrasonography examination of breast and axilla, and a full general assessment to eliminate distant metastasis.

Local recurrences will be operated by breast conservative surgery (BCS) or mastectomy. The decision between BCS and mastectomy will be carefully considered, in accordance with patient preference and other clinical features such as tumor location, tumor size, and breast size taken into account.

Each patient will have a second SLNB followed by a systematic complete ALND. Before the SLNB procedure, each patient will have a lymphoscintigraphy to evaluate axillary and extra axillary lymphatic mapping. Lymphoscintigraphy will be performed according to previously reported standard techniques. At 2-20 h after lymphoscintigraphy, SLNB will be performed with or without a blue dye associated injection. An intraoperative gamma ray detection probe will be used during surgery to conﬁrm locations of the sentinel nodes and to facilitate their removal. All sentinel nodes will be removed and sent for histopathologic examination according to previously described standard techniques. A complete ALND (Berg's stage I and II) will be realized and the nodes will be sent for standard histopathologic examination.

Further systemic adjuvant therapies will be chosen in a multidisciplinary approach considering prognostic and predictive indicators.

All the patients will be followed up for 5 years at 12-month intervals after the second surgery and undergo annual mammography with or without ultrasonography.

Sentinel Lymph Node Procedure in Ipsilateral Invasive Breast Cancer Relapse

Feasibility and Accuracy of Lymph-node (LN) Restaging by Sentinel LN Procedure and Axillary LN Dissection in Ipsilateral Invasive Breast Cancer Relapse

Ratio of the number of cases with detection of negative sentinel axillary lymph node but with at least one metastatic lymph node in the axillary dissection on the total number of patients with at least one detected a sentinel axillary node and at least one metastatic lymph node, either in a sentinel axillary lymph node or in complete ALND

Ratio of the number of patients injected, technetium +/- blue, in which at least one sentinel axillary lymph node was detected intraoperative on the total number of patients injected

% of patient requiring consolidation radiotherapy on axillary and extra-axillary lymph node sites

Lymphoscintigraphy will be performed within 24 hours before surgery

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Multiparametric MRI in Men With Prostate Cancer Enrolled in Active Surveillance	NCT03648359	Prostatic Neopl...	multiparametric...	18 Years - 75 Years	Herlev Hospital
Validation of the CPS+EG, Neo-Bioscore and Modified Neo-Bioscore Staging Systems After PST of BC in China	NCT03437837	Breast Cancer Neoadjuvant The... Neoplasm Stagin... Estrogen Recept... Histological Gr... HER2 Prognosis Predictive Valu...		18 Years - 75 Years	Peking University First Hospital
Hemoglobin, Neutrophil to Lymphocyte Ratio and Platelet Count Improve Prognosis Prediction in Nasopharyngeal Carcinoma	NCT02211677	Nasopharyngeal ... Blood Cell Coun... Neoplasm Stagin... Prognosis		18 Years - 75 Years	Sun Yat-sen University
Multiparametric MRI in Men With Prostate Cancer Undergoing Active Surveillance	NCT02526797	Prostatic Neopl...		18 Years - 75 Years	Herlev Hospital
FAPI and FDG PET/MRI in Diagnosis and Therapy Prediction of Bladder Cancer	NCT06421142	Urinary Bladder...	imaging examina...	18 Years - 80 Years	First Affiliated Hospital of Fujian Medical University
FAPI and FDG PET/MRI in Diagnosis and Therapy Prediction of Bladder Cancer	NCT06421142	Urinary Bladder...	imaging examina...	18 Years - 80 Years	First Affiliated Hospital of Fujian Medical University
Diagnostic Comparison of PET-magnetic Resonance and PET-CT in Patients With Oncologic Diseases	NCT02316431	Neoplasm Stagin...		18 Years - 90 Years	University of Zurich
Pre-operative PET-MR of High Risk Prostate Cancer Patients for Assessment of Cancer Aggressiveness and Lymph Node Status	NCT02076503	Prostatic Neopl...	PET-MR 18f-FACB... histology (gold...	-	St. Olavs Hospital
Evaluation of Modern MRI in the Diagnosis of Prostate Cancer in a Danish Setup	NCT01640262	Prostatic Neopl...	Multiparametric...	18 Years -	Copenhagen University Hospital at Herlev
Pre-operative PET-MR of High Risk Prostate Cancer Patients for Assessment of Cancer Aggressiveness and Lymph Node Status	NCT02076503	Prostatic Neopl...	PET-MR 18f-FACB... histology (gold...	-	St. Olavs Hospital
Sentinel Lymph Node Procedure in Ipsilateral Invasive Breast Cancer Relapse	NCT03630653	Invasive Breast... Ipsilateral Rec... Sentinel Lymph ...	Sentinel LN in ...	18 Years -	Institut Cancerologie de l'Ouest

Spots Global Cancer Trial Database for neoplasm staging