Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Dermatologic Agents

All Drugs and Chemicals

Coal Tar

CT scan (neck/thorax/abdomen/pelvis) and WB-MRI

All patients will undergo a CT scan (neck/thorax/abdomen/pelvis) and a WB-MRI

WB-MRI

Giuseppe Petralia, MD

This is a non randomized, single arm study, where each patient will undergo imaging with Computed Tomography (CT) and Whole-body magnetic resonance imaging (WB-MRI) at different timepoint. The primary endpoint is time to progression as documented by CT or WB-MRI.

This is a monocentric study. All patients will undergo assessments by CT and WB-MRI at all time points.

* A baseline bone scan or Fluorodeoxyglucose-Position Emission Tomography (FDG-PET) will be performed.
* CT scans and WB--MRI are performed every 12 weeks until week 96, and then every 24 weeks until disease progression is evident (as defined in section 7.1.3).
* At the point of disease progression, a repeat bone scan or FDG-PET/CT will be obtained in addition to the CT and WB-MRI. Participation in the trials ends at the point of disease progression.

Patients will be reviewed in outpatient clinic:

* At baseline
* Every 12 weeks until week 96, with the results of their recent scans.
* As with the imaging, the trial visits will change to every 24 weeks after the week 96 visit.

At the week 12 and week 36 visits, the patients will undergo a clinical examination and perform a pain thermometer score and Patient Imaging Questionnaire.

Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone

Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone: A Whole Body MRI Study MILANO : RESPECT-MI

Number of patients where disease progression in bone metastases were identified using WB-MRI prior to identification by CT scan

European Institute of Oncology

Urinary Tract, Sexual Organs, and Pregnancy Conditions

Prostatic Neoplasms

Genital Neoplasms, Male

Urogenital Neoplasms

Genital Diseases

Genital Diseases, Male

Urogenital Diseases

Prostatic Diseases

Male Urogenital Diseases

Each patient will undergo imaging with CT, BS and WB-MRI at each study timepoint

each patient will undergo imaging with CT, BS and WB-MRI at each study timepoint

Imaging evaluation

Giuseppe Petralia

This study is aimed to compare whole body MRI (WB-MRI) with Bone Scintigraphy (BS) and Computerized Tomography (CT) scans in patients receiving treatment for metastatic castration-resistant prostate cancer to the bone.

This is a monocentric, prospective observational study.

This is an observational study and will not influence the choice of treatment. The treating clinicians will be able to use any clinical treatment regimen that is considered appropriated for the patient. This may include hormonal therapy or chemotherapy or therapy with radium-223. In addition, patients may be treated with bisphosphonates/denosumab, and granulocity-colony stimulating factor. The duration of therapy, doses, schedules, timing, premedication, patient monitoring during treatment, dose adjustments, and duration of therapy are entirely at the discretion of the treating clinician.

The use of radiotherapy is permitted, but the details including fields used must be communicated to the reporting radiologist to ensure this does not affect the interpretation of imaging. All other supportive or palliative treatments are permitted.

All patients will undergo imaging assessments as follows:

* At baseline, CT, BS (99mTc-MDP) and Whole Body-Magnetic Resonance Imaging (WB-MRI) will be performed.
* Follow-up imaging will be CT, BS and WB-MRI performed every 12 weeks until week 96, and then every 24 weeks until disease progression occurs or week 192.

Additional patient assessments to be performed include:

* questionnaires at baseline, week 36 and end of study to evaluate patient perception, acceptance and preferences regarding the imaging modalities.
* clinical and physical examinations according to routine clinical practice. The radiologist reporting the WB-MRI will be blinded to the results of the CT and BS.

The radiologist reporting the CT and the nuclear medicine physician reporting the BS will likewise be blinded to the results of the WB-MRI.

Neither treating clinicians nor patients will be blinded at any point.

Response Evaluation of Cancer Therapeutics in Metastatic Castration-Resistant Prostate Cancer to the Bone

Response Evaluation of Cancer Therapeutics in Metastatic Castration-Resistant Prostate Cancer (mCRPC) to the Bone: A Whole Body MRI Study

the proportion of WB-MRI examinations that identify disease progression in bone metastases prior to CT + BS

Nervous System Diseases

Diseases and Abnormalities at or Before Birth

Symptoms and General Pathology

Rare Diseases

Neurofibromatoses

Neurofibromatosis 1

Neurofibroma

Nerve Sheath Neoplasms

Neurofibrosarcoma

Neoplasms, Nerve Tissue

Neoplasms by Histologic Type

Syndrome

Neoplastic Syndromes, Hereditary

Neurocutaneous Syndromes

Heredodegenerative Disorders, Nervous System

Neurodegenerative Diseases

Genetic Diseases, Inborn

Peripheral Nervous System Diseases

Neuromuscular Diseases

Nervous System Neoplasms

Peripheral Nervous System Neoplasms

Fibrosarcoma

Neoplasms, Fibrous Tissue

Neoplasms, Connective Tissue

Neoplasms, Connective and Soft Tissue

Sarcoma

Neurofibromatosis

Neurofibromatosis Type 1

Malignant Peripheral Nerve Sheath Tumor

Soft Tissue Sarcoma

Magnetic resonance imaging of the entire body from skull base through distal thighs/knees without contrast material

Whole Body Magnetic Resonance Imaging

Shivani Ahlawat, PhD

Shivani Ahlawat, MD

The goal of this prospective observational study is to learn about the utility of imaging and clinical features in patients with Neurofibromatosis type 1 categorized as high risk for the development of malignant peripheral nerve sheath tumors.

The main objectives are:

* To evaluate the prevalence, multi-parametric imaging features of distinct nodular lesions ("DNLs") and natural history in people with NF1 with clinical and genetic features deemed "high-risk" for malignancy.
* To assess the relationship between individual clinical, genetic and imaging factors that have been suggested to be risk factors for malignant peripheral nerve sheath tumors (MPNST) and the confirmation of atypical neurofibromas (aNF)/ atypical neurofibromatous neoplasm of unknown biologic potential (ANNUBP) or MPNST on pathology.

In this research study, the participants will be asked to undergo whole body MRI, provide blood sample and clinical evaluation annually.

Patients with the autosomal dominant genetic tumor predisposition syndrome neurofibromatosis type 1 (NF1) have an increased risk of developing both benign and malignant neoplasms throughout life. The most common tumors are peripheral nerve sheath tumors (PNSTs) such as plexiform neurofibromas (pNFs). pNFs are multicellular primary tumors of the peripheral nerve that are histologically benign but often cause significant neurologic morbidity due to involvement of critical nerves. However, the greatest fear is the development of malignant peripheral nerve sheath tumors (MPNSTs). MPNST is an aggressive, treatment resistant sarcoma with a 5-year survival rate of only 15-50% and is the leading cause of death in NF1 patients, especially in those under 50 years of age. An estimated 50% of NF1 patients develop pNFs and the lifetime risk of developing MPNST is 8-13%. The only possible cure for MPNST is complete resection with wide negative margins. This is only feasible if the lesion can be clearly defined and removed without life-threatening morbidity. A major challenge to clearly differentiating between MPNSTs and pNFs is that the vast majority of MPNSTs arise within pNFs. This intimate association makes it hard to distinguish MPNST clinically, radiologically, and pathologically from surrounding benign tissue, thus leading to delayed diagnosis until after symptoms (such as severe pain and loss of neurologic function) have emerged and the chance for cure is greatly diminished or lost. A great deal of time, resource and worry from patients, the patients loved ones and medical providers is dedicated to detecting MPNSTs early at great expense and unclear benefit.

Existing clinical factors and imaging markers of MPNST do not accurately identify patients at risk of developing either MPNST or the patients precursor tumors. Retrospective studies from various centers have suggested several clinical factors associated with the development of MPNST including: number and volume of internal PNSTs, presence of subcutaneous neurofibromas, younger age, presence of pain, microdeletion of the NF1 gene, family and personal history of MPNST, and presence of atypical neurofibromas (aNF)/ANNUBPs. None of the imaging diagnostic tools studied in NF1 patients have been prospectively assessed to identify aNF/ANNUBP. Natural history studies and clinical trials using MRI have identified nodular target lesions within pre-existing pNFs on standard anatomic MRI as potential precursor lesions to MPNST that may represent aNF/ANNUBP. These lesions have been coined "distinct nodular lesions" (DNLs) and described as greater than 3 cm in largest diameter, well demarcated, distinct from the patients underlying tissue (i.e. the surrounding pNF), and lacking the target sign typical of benign pNFs (defined as a central hypointense region on T2-weighted images). In a recent retrospective review of 76 histologically confirmed aNFs, all aNFs fulfilled the criteria for DNLs on MRI and 50 of 56 aNFs with available 18F-2-fluoro-2-deoxy-D-glucose fluorodeoxyglucose positron emission testing computed tomography (18F-FDG PET/CT) demonstrated elevated maximum standardized uptake value (SUVmax) (\>3.5), supporting the hypothesis that DNLs may be the imaging correlate of pre-malignant tumors.

The investigators hypothesize that NF1 patients with aNF/ANNUBP represent a subset of individuals who have not developed cancer yet but who are at high risk of developing a malignancy, possibly in the short term. the investigators further hypothesize that a subset of DNLs are imaging correlates of aNF/ANNUBP that can be characterized with advanced imaging techniques such as Diffusion weighted imaging (DWI) and 18F-FDG PET/CT. Imaging identification of ANNUBPs and characterization of DNLs will enable early diagnosis and management of lesions destined to become malignant, thereby potentially dramatically improving outcomes for People with NF1 at highest risk for development of MPNST.

Defining the prevalence of DNL in a population clinically to be at high-risk for future development of malignancy, the behavior of DNLs over time and the multi-parametric imaging features of DNLs will allow the generation of imaging markers to: (1) identify the specific lesions at highest risk for malignancy in a sea of lesions, (2) understand the biologic significance of these lesions and, (3) create the data about the optimal imaging marker for these lesions to inform evidence based guidelines for imaging in people with NF1.

2. Objectives (include all primary and secondary objectives):

* To evaluate the prevalence, multi-parametric imaging features of distinct nodular lesions "DNLs" and natural history in people with NF1 with clinical and genetic features deemed "high-risk" for malignancy.
* To assess the relationship between individual clinical, genetic and imaging factors that have been suggested to be risk factors for MPNST and the confirmation of aNF/ANNUBP or MPNST on pathology.

Multi-parametric Biomarker Development to Predict Malignant Conversion in Patients With Neurofibromatosis Type 1

Prevalence of distinct nodular lesions in people with NF1 associated pNF and clinical or genetic factors that are hypothesized to be "high risk" for MPNST

The imaging characteristics of DNL over time

Incidence of new DNLs over time (in both people who do and do not have DNL on initial imaging)

The imaging characteristics of pNF (independent of DNL) over time in people hypothesized to be "high risk" for MPNST

Frequency of biopsy in people with and without DNL.

Johns Hopkins University

Technetium Tc 99m Medronate

Patients will have repeat CT (Computerised Tomography) scans and WB-MRI (Whole Body Magnetic Resonance Imaging) every 12 weeks until disease progression. A baseline bone scan (99mTc-MDP) will be performed.

At the point of disease progression, a repeat bone scan will be obtained in addition to the CT and WB-MRI.

Patients will be given the opportunity to participate in a sub-study of WB-MRI reproducibility. This involves a repeat scan of the Whole Body Magnetic Resonance Imaging (WB-MRI) diffusion-weighted sequences. This will be shorter in duration than the full WB-MRI scan and will take place within one hour of completing the full WB-MRI scan.

Computerised Tomography

Bone scan

Dr Andreas Makris

This trial is a feasibility study prior to a planned phase III trial. Currently, assessing response to treatment of metastatic breast cancer in the bone is limited by the technical problems associated with CT scans and bone scans. WB-MRI provides theoretical and practical advantages that allow for more detailed analysis of disease response or progression. This may allow for earlier identification of progressive disease and earlier change in treatment.

Participants in the study will have a CT scan, bone scan and WB-MRI at baseline and then repeated CT and WB-MRI scans every 12 weeks (until week 96, and then every 24 weeks) until there is evidence of progressive disease on either of the imaging modalities. In addition to the regular scans on the study, patients will be given the opportunity to participate in a study of how reproducible the findings of WB-MRI scans are. At the point of disease progression, a repeat bone scan is performed and the involvement of the patient in the trial comes to an end.

Patients are eligible for RESPECT if they have bone-only metastatic breast cancer (MBC), as established by standard CT and bone scintigraphy, and are starting a new line of systemic therapy. This can be first line SACT or any subsequent line.

All patients undergo a baseline CT scan (thorax/abdomen/pelvis) and isotope bone scan prior to commencing their new systemic therapy. All CT and bone scans are performed according to standard departmental protocols, with no deviations required. WB-MRI are performed within 2 weeks of study entry. CT scans and WB-MRI are then performed every 12 weeks until week 96, and then every 24 weeks until the patient completes the study. The reporting radiologist who interprets the CT scans is blinded to the images and results of the WB-MRI scan and vice versa.

At study commencement Participants are required to have had a CT scan of the thorax, abdomen and pelvis and a bone scan (bone scintigraphy with technetium-99m-methylene diphosphonate) no more than 4 weeks prior to trial entry to ensure that they have bony-only metastatic disease, as defined using standard imaging. Baseline WB-MRI scans are performed within 2 weeks of entry into the study.

Participants are assessed in clinic and a baseline physical examination is undertaken. Any additional tests required for the initiation of the new SACT are performed at the discretion of the treating clinician and according to local protocols.

During the study CT scans and WB-MRI are performed every 12 weeks until week 96, and then every 24 weeks until disease progression is evident (as defined in the study protocol). Scans are performed within the range of 7 days prior and 7 days after the planned 12 weekly scan interval date.

If there is evidence of equivocal disease progression on WB-MRI only, a repeat WB-MRI is undertaken between 28 and 42 days after the equivocal WB-MRI to confirm or refute the presence of progressive disease. If this confirmed disease progression, then the date of progression is defined as that of the original WB-MRI (i.e. the one performed 4-6 weeks earlier). No repeat CT scans are performed alongside the confirmatory WB-MRI.

Participants are reviewed in outpatient clinic after every imaging time point so that the results of the CT and WB-MRI can be relayed to them by their oncologist and a decision can be made about their ongoing treatment. If more frequent clinic reviews are required then these are not prohibited by the trial protocol. As with the frequency of imaging, the required trial clinic visits change to every 24 weeks after the week 96 visit. During these clinic visits a clinical assessment is made and a full physical examination undertaken. Current anti-cancer drug therapy, including any changes, are documented. Any skeletal related events are also documented. Skeletal related events are defined within the RESPECT study as:

* pathological fracture
* metastatic spinal cord compression
* radiotherapy for bone pain
* surgery to site of bone metastasis Case report forms are completed by the trial administrators at every imaging time point. These are referred to as week 12, week 24, week 36 and so forth.

Patient Imaging Questionnaires are performed at the week 12 and week 36 visits, and are completed by the patients within the radiology department soon after their CT and WB-MRI scans has been performed.

End of study

The end of the study protocol is reached when any of the following occur:

1. Progressive bone and/or visceral disease is demonstrated on CT scan and WB-MRI (as defined in section X).
2. Unequivocal progressive bone and/or visceral disease is demonstrated on WB-MRI alone (as defined in section X).
3. CT and/or WB-MRI findings requiring intervention such as palliative radiotherapy, or a change in systemic therapy.
4. Equivocal evidence of progressive bone and/or visceral disease (not meeting the full criteria for disease progression in section 7.1.3) demonstrated on WB-MRI only, with confirmation of findings on repeat WB-MRI undertaken 4-6 weeks later.
5. Symptomatic skeletal disease or evidence of clinical progression of disease that necessitates a change in systemic therapy.

A repeat nuclear medicine bone scan is undertaken once the participant met one of the end of study criteria above.

The reporting radiologist of the WB-MRI will be blinded to the results of the CT. The reporting radiologist of the CT will also be blinded to the results of the WB-MRI. Neither treating clinicians nor patients will be blinded at any point.

Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone: A Whole Body MRI Study

All patients can agree to their data being used for future research.

Description of the metric used to characterize the specific primary outcome measure, if not included in the primary outcome measure title.

Time point(s) at which the measurement is assessed for the specific metric used. The description of the time point(s) of assessment must be specific to the outcome measure and is generally the specific duration of time over which each participant is assessed (not the overall duration of the study).

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone	NCT06321666	Metastatic Brea...	WB-MRI	18 Years -	European Institute of Oncology
Response Evaluation of Cancer Therapeutics in Metastatic Castration-Resistant Prostate Cancer to the Bone	NCT06321679	Castration-resi...	Imaging evaluat...	18 Years -	European Institute of Oncology
Multi-parametric Biomarker Development to Predict Malignant Conversion in Patients With Neurofibromatosis Type 1	NCT05677594	Neurofibromatos... Malignant Perip... Atypical Neurof...	Whole Body Magn...	6 Years -	Johns Hopkins University
Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone: A Whole Body MRI Study	NCT03266744	Metastatic Brea...	Computerised To... Whole Body Magn... Bone scan	18 Years -	East and North Hertfordshire NHS Trust
Response Evaluation of Cancer Therapeutics in Metastatic Castration-Resistant Prostate Cancer to the Bone	NCT06321679	Castration-resi...	Imaging evaluat...	18 Years -	European Institute of Oncology
Response Evaluation of Cancer Therapeutics in Metastatic Breast Cancer to the Bone: A Whole Body MRI Study	NCT03266744	Metastatic Brea...	Computerised To... Whole Body Magn... Bone scan	18 Years -	East and North Hertfordshire NHS Trust

Spots Global Cancer Trial Database for whole body magnetic resonance imaging