Neoplasms

Urinary Tract, Sexual Organs, and Pregnancy Conditions

All Conditions

Urinary Bladder Neoplasms

Urologic Neoplasms

Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urinary Bladder Diseases

Urologic Diseases

Male Urogenital Diseases

Patients will undergo MRI followed by TURBT

In our study we aim to evaluate role of Multiparametric MRI in differentiation between invasive and non-invasive bladder cancer and accuracy of vesical imaging reporting and data system (VI-RADS) score.

multi parametric MRI

detection of degree of invasion to test accuracy of ViRADS score

transurethral resection of bladder tumor

ahmed Tawfeek, ass. Professor

eslam mohamed

To evaluate the accuracy of Multiparametric MRI in differentiation between invasive and non-invasive bladder cancer using vesical imaging reporting and data system (VI-RADS) score.

Bladder cancer (BC) is one of the most common and expensive human malignancies to manage. Most BCs are urothelial cell carcinomas (UCCs), and histologically stratified into cancers with low and high grade. The latter are subdivided into those with and without muscle invasion.(1) Non-muscle-invasive BCs (NMIBCs) are often low grade and have an indolent natural history. Muscle-invasive BCs (MIBCs) are aggressive tumors with an ominous prognosis. (2) Non-muscle invasive bladder cancer is treated with transurethral resection of bladder tumor with or without adjuvant intravesical chemotherapy or photodynamic therapy, whereas muscle-invasive bladder cancer is treated with radical cystectomy, radiation therapy, chemotherapy, or a combination(3).

Bladder cancer staging is accomplished by the combination of clinical (examination), pathologic (transurethral resection of bladder tumor specimens), and radiologic means. The quality of the transurethral resection of bladder tumors often varies among surgeons, and it may miss muscle infiltration in up to 25% of invasive cancers. (4) Radiological examination looks for second urinary tract malignancies (5% of BCs may have an upper tract UCC) or other pathologies. Most guidelines suggest cross-sectional imaging for MIBCs and high-grade NMI cancers, due to the risks of invasion and regional or distant metastases, and upper urinary tract involvement. (5) MRI is currently the best imaging technique for bladder cancer local regional staging because of its superior soft tissue contrast, lack of ionizing radiation, in addition, it clearly differentiates the layer of bladder wall and enables accurate assessment of tumor depth invasion in bladder wall and extra-vesical extension. (6) During the past few years, important improvements in MRI technology have been achieved and led to the introduction of Multiparametric MRI (mp MRI) which combines functional sequences as diffusion weighted imaging (DWI) and dynamic contrast enhanced MRI (DCE-MR) with anatomic T1 and T2 weighted images (T1 and T2WI), that improves the accuracy of tumor detection and staging, helps to monitor post-therapy response and identify local disease recurrence. (7) Recently also standardized approach for imaging and reporting mp-MRI for bladder cancer was created by developing VI-RADS score (Vesical Imaging Reporting and Data System). This aims to standardize bladder mpMRI for clinical and research applications to create a systematic approach for reporting bladder mp-MRI and defining the risk of muscle invasion (NMIBC versus MIBC). (8) The Final VI-RADS score is generated using all categories and suggests the probability of muscle invasion ,It's graded from VIRADS 1 (muscle invasion is highly unlikely) to VI-RADS 5 (ivasion of muscle and beyond the bladder is very likely) (9) In our study we aim to evaluate role of Multiparametric MRI in differentiation between invasive and non-invasive bladder cancer and accuracy of vesical imaging reporting and data system (VI-RADS) score.

2- AIM:

To evaluate the accuracy of Multiparametric MRI in differentiation between invasive and non-invasive bladder cancer using vesical imaging reporting and data system (VI-RADS) score.

Validation of VI-RADS for the Detection of Detrusor Muscle Invasion

Multiparametric MRI for Bladder Cancer: Validation of VI-RADS for the Detection of Detrusor Muscle Invasion

Ain Shams University

Egyptian Biomedical Research Network

Assistant Professor of Urology

Prostatic Neoplasms

Genital Neoplasms, Male

Genital Diseases

Genital Diseases, Male

Prostatic Diseases

If the clinical suspicion of cancer is low, there will be no biopsy, only follow-up. If the decision is to perform a biopsy on the prostate, it will be performed with transrectal sonar guidance and systematic biopsies will be performed (12 samples will be taken from different areas of the prostate)

If MRI and PET are matched, a US FUSION MRI biopsy will be taken between 4-8 samples directly from the lesion as well as other systemic prostate samples according to the surgeon's decision. Will be taken and sent separately to pathology.

A FUSION approach will be biopsy. Four to eight samples for each lesion, as well as other systemic prostate samples will be taken according to the surgeon's decision, and the samples will be marked and sent separately to the pathology.

Biopsies are part of standard procedures in the patients recruited and will not be done due to this study.

Biopsy

David Groshar, MD

Prostate cancer is a common disease in men. In prostate 35% of biopsies, usually done due to increased PSA levels or clinical suspicion, are false negative, despite malignancy.

Multi-parametric prostate MRI detects malignant neoplasm lesions better than other imaging devices.

A sonar-guided prostate biopsy based on multi-parametric MRI images improves detection of malignancy. Ga68 PSMA-PET test uses a radioactive marker that binds to the prostate's cells and is shown to be a primary prostate tumor site in addition to metastasis.

We believe that the combination of measures from a single Ga68 PSMA and multi-parametric MRI test can lead to further improvement in malignancy, better biopsy guidance, and optimal treatment for the patient.

Prostate cancer is the most common and second leading cause of cancer death in men.

Mostly, patients undergo prostate biopsy whenever abnormal digital rectal examination or elevated prostate specific antigen (PSA) levels have been found. Traditionally, trans-rectal US (TRUS) biopsy is performed using 10-12 needles that are inserted into different areas of the prostate gland. Despite this, up to 35% of prostate cancers are still not diagnosed.

The use of multi-parametric prostate MRI (mnMRI) in which T2-weighted sequence, diffusion weighted imaging (DWI) and dynamic contrast enhanced-imaging (DCE) are used has shown to increase the cancer detection rate of clinically significant lesions and better stratify prostate cancer compared to other modalities(3). A pre-biopsy mnMR can identify suspicious lesions that can be targeted on biopsy. Indeed, the use of MRI- US fusion in which pre-biopsy MR images are incorporated with real time biopsy US images has shown to reduce the number of biopsies performed on patients with low grade cancer and increase the detection of intermediate-high risk subgroups of patients(4).

The introduction of PET/MR with the use of PSMA as a radiotracer offers the potential to add a new biomarker to the well-established mnMRI. Different PSMA metrics such as SUV, metabolic tumor volume (MTV) and kinetic parameters can be correlated with lesion detection rate and Gleason score and help tailoring the precise treatment to patients.

The purpose of the current study is to reveal if PSMA-PET has an added value in the detection and stratification of prostate cancer to the currently used nmMRI.

First Objective: To examine whether PSMA-PET increases detection sensitivity and allows better classification of prostate lesions.

Secondary objective: To check the correlation between PSMA-PET measurements and the various indices of multi-parametrial MRI and the histological results.

The work hypothesis: The PSMA PET MRI measurements will improve the ability to identify and classify prostate lesions and conform to the various MRI measurements Research Methods-

The study population:

Patients who have a clinical suspicion of prostate cancer that will be referred to the prostate multi-parameter MRI before deciding on a prostate biopsy Sampling Method: The study is prospective and will include subjects who meet the criteria for inclusion in a continuous manner. The subjects will undergo a PET MRI PSMA test, followed by a prostate fusion biopsy (up to two weeks after the test) using US fusion technology.

Parameters of the PSMA PET-MR test :

PET Measurements: Quantitative calculation of the absorption of suspicious lesions.

The type of biopsy will depend on the PET MRI results. If a suspicious finding is found according to the PET or MR test or both, the biopsy will be done using the US FUSION MRI, and if a suspicious lesion is not seen, the biopsy will be performed by sonar alone, or not at all.

Sample size: 70 participants.

The Value of PSMA-PET Compared With Multi-parametric MRI in the Detection Prostate Lesions

Evaluation of the Added Value of PSMA-PET Compared With Multi-parametric MRI in the Detection and Classification of Prostate Lesions

PET Measurements vs. clinical measurements

Assuta Medical Center

Proffesor

Advanced Ultrasound assessment of the prostate

Prostate HistoScanning

Multi-sequence Magnetic resonance imaging of the prostate

Multi-parametric MRI

Needle biopsy of the perineum via the transperineal route at 5mm intervals guided by the use of ultrasound.

Transperineal prostate mapping biopsy

Biopsies targeted to lesions seen at a) Prostate HistoScanning and b) mp-MRI. In men with an MRI lesion further MRI/US registration biopsies will be obtained

Image guided biopsies

Lucy AM Simmons, MBBS

Lucy AM Simmons, MBBS, MRCS

Hashim Uddin Ahmed, MBBS, MRCS

Caroline M Moore, MBBS,MD,FRCS

Mark Emberton, MBBS,MD,FRCS

The incidence of prostate cancer is rising however the number of deaths from prostate cancer is stable. Meaning the investigators are diagnosing many men with prostate cancer that will not impact on their life. The rise in incidence is mainly due to increased use of the blood test Prostate Specific Antigen (PSA), as a screening test.

Currently men suspected of having prostate cancer, identified by a raised PSA undergo trans-rectal ultrasound guided prostate biopsy (TRUS biopsy). Many men have this test unnecessarily, only 1/3 being diagnosed with prostate cancer. TRUS biopsy is problematic as it is random and performed blind-the operator does not know where the cancer is. Thus many low-risk cancers that do not need treating are diagnosed and many high risk cancers are missed or incorrectly classified. So, men with a negative biopsy or those with low risk disease are usually advised to undergo another TRUS biopsy.

An imaging test is needed that could help men and their doctors decide whether the biopsy is a true reflection of what is inside his prostate.

The investigators will test the role of two imaging tests. The first, multi-parametric magnetic resonance imaging (mp-MRI) uses magnetic signals from the body to form images. The second, Prostate HistoScanning™ (PHS) uses sound-waves. The investigators will compare the results of these tests with a detailed biopsy map-transperineal template prostate mapping biopsy (which is currently the best way to find out what is in the prostate but requires multiple biopsies to be taken under general anaesthetic. Eligible men will have undergone one or more TRUS biopsies and who have been advised to have further tests on as part of standard of care. They will be recruited from UCLH referral letters and clinics.

The investigators aim is to see if either of these tests can confidently rule out the presence of clinically important disease.

Imaging for Significant Prostate Cancer Risk Evaluation

PICTURE - Prostate Imaging (Multi-parametric MRI and Prostate HistoScanning™) Compared to Transperineal Ultrasound Guided Biopsy for Significant Prostate Cancer Risk Evaluation.

Performance characteristics of mp-MRI for ruling out CLINICALLY SIGNIFICANT prostate cancer as determined by negative predictive value and specificity

Performance characteristics of Prostate HistoScanning for ruling out CLINICALLY SIGNIFICANT prostate cancer as determined by negative predictive value and specificity

Negative predictive value of Imaging compared to Transperineal template Mapping prostate biopsy.

Number of men correctly identified by each test to have clinically significant disease as detected by Transperineal Template Mapping Biopsy

The reproducibility of Prostate HistoScanning will be assessed by looking at the predicted cancer volume and location of the HistoScanning investigation at two time points.

Performance characteristics of MRI/US registration targeted biopsies compared to i) systematic biopsies and ii) cognitive targeted biopsies in prostate cancer risk stratification as determined by sensitivity and specificity

Assessment of alterations in Lower Urinary tract function following Transperineal Template Mapping Biopsy

IPSS, IPSS-QoL, Continence Function Questionnaire.

Assesment of erectile function compared to baseline will be made using questionnairres.

IIEF

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Validation of VI-RADS for the Detection of Detrusor Muscle Invasion	NCT05123404	Bladder Cancer	multi parametri... transurethral r...	-	Egyptian Biomedical Research Network
The Value of PSMA-PET Compared With Multi-parametric MRI in the Detection Prostate Lesions	NCT03174054	Prostate Cancer	Biopsy	40 Years - 95 Years	Assuta Medical Center
Validation of VI-RADS for the Detection of Detrusor Muscle Invasion	NCT05123404	Bladder Cancer	multi parametri... transurethral r...	-	Egyptian Biomedical Research Network
The Value of PSMA-PET Compared With Multi-parametric MRI in the Detection Prostate Lesions	NCT03174054	Prostate Cancer	Biopsy	40 Years - 95 Years	Assuta Medical Center
Imaging for Significant Prostate Cancer Risk Evaluation	NCT01492270	Prostate Cancer	Prostate HistoS... Multi-parametri... Transperineal p... Image guided bi...	20 Years -	University College London Hospitals

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