Neoplasms

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Urinary Tract, Sexual Organs, and Pregnancy Conditions

Rare Diseases

Carcinoma

Urinary Bladder Neoplasms

Carcinoma, Transitional Cell

Urinary Bladder Diseases

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Urogenital Neoplasms

Urogenital Diseases

Female Urogenital Diseases

Pregnancy Complications

Female Urogenital Diseases and Pregnancy Complications

Urologic Diseases

Male Urogenital Diseases

Transitional Cell Carcinoma

Vesical Imaging-Reporting And Data System (VI-RADS) using multi-parametric MRI.

Vesical Imaging-Reporting And Data System (VI-RADS) for predicting non-muscle invasive bladder cancer (NMIBC) using multi-parametric MRI.

Multi-parametric MRI

Ahmed Mosbah, MD

Mohammed Aboelghar, MD

Vesical Imaging-Reporting And Data System (VI-RADS) is proposed for predicting muscle invasive bladder cancer (MIBC) using multi-parametric MRI. However, No validation study on VI-RADS has been reported yet. Apparent diffusion coefficient (ADC) values on diffusion-weighted MRI are reportedly significantly lower in MIBC than those in non-MIBC(NMIBC).

Vesical Imaging-Reporting And Data System (VI-RADS) is proposed for predicting muscle invasive bladder cancer (MIBC) using multi-parametric MRI. However, No validation study on VI-RADS has been reported yet. Apparent diffusion coefficient (ADC) values on diffusion-weighted MRI are reportedly significantly lower in MIBC than those in non-MIBC(NMIBC).

We aim to examine the accuracy of VI-RADS for predicting MIBC in final histopathology specimen. To assess whether incorporating ADC into VI-RADS improves the MIBC predictive accuracy of VI-RADS

Can VI-RADS/ADC Accurately Stage Bladder Cancer??

Can Vesical Imaging-Reporting And Data System and Apparent Diffusion Coefficient Values (the VI-RADS/ADC) Accurately Predict Non-Muscle Invasive Bladder Cancer

assessed by final histopathology specimen retrieved by enbloc transurethral resection of bladder tumors (ERBT)

Mansoura University

Principal Investigator

Antineoplastic Agents

All Drugs and Chemicals

Atezolizumab

Immunomodulating Agents

Immune Checkpoint Inhibitors

Antineoplastic Agents, Immunological

Flat dose 1200 mg Atezolizumab every three weeks for up to 13 months

The study drug will be given according to current recommendations as systemic treatment every third week for 12 months or until progression. Treatment will be initiated within 28 days of detection of ctDNA.

Jørgen B Jensen, MD, DMSc

Lars Dyrskjøt, Professor

Astrid Livbjerg, MD

Andreas Carus, MD

Jørgen B Jensen, MD

Mads Agerbæk, MD

Ulla N Joensen, MD

Helle Pappot, MD

Gitte W Lam, MD

Line H Dohn, MD

Thor K Jensen, MD

Niels V Jensen, MD

Jørgen B Jensen, Professor

Karin Birkenkamp-Demtröder, Ass. professor

Immunotherapy (checkpoint inhibitors) is approved as first and second line treatment to patients with metastatic bladder cancer. However, response rates are low and no biomarkers have yet shown strong predictive value for patient selection. Moreover, the term 'metastatic' is based on metastases visible on conventional CT scans and, thus, require a certain size of tumour load. Clinical trials are currently being conducted that investigate the use of adjuvant immunotherapy for this group of patients (treatment to all), which will result in massive over-treatment and huge costs to the healthcare system.

This project has the primary objective to identify new indications for initiating immunotherapy in patients with metastatic bladder cancer. Sensitive molecular techniques for detection of tumor DNA in the blood will be used to identify patients with early signs of metastatic disease. In addition, comprehensive biomarker analysis will be performed to identify predictors of treatment response.

The study aim at investigate the response rate and oncological outcome of systemic immunotherapy (PDL-1 inhibitor; atezolizumab) administered early at the time of biochemical relapse (circulating tumor DNA (ctDNA) positive) in patients who have undergone radical cystectomy because of muscle invasive bladder cancer.

Biomarkers that predict response to systemic immunotherapy will be identified by comprehensive multi-omics analysis of primary tumors and metastatic lesions. Furthermore, we will determine if ctDNA levels during therapy can be used as a biomarker for early indication of therapy response.

The hypotheses is that 1) early initiation of immunotherapy in high-risk (ctDNA positive) patients will result in better response rates and improved survival compared to later treatment following conventional imaging diagnosis of metastasis, and 2) biomarkers for predicting response can be identified and used for tailoring treatment regimens in the future to patients at high risk and at high likelihood of response.

Single country Investigator Initiated, Open-label, Single-arm, Non-randomized, Phase II study

Treatment Of Metastatic Bladder Cancer at the Time Of Biochemical reLApse Following Radical Cystectomy

CR in the current study is defined as ctDNA negative status combined with regular imaging (CT) after treatment. Thus, any metastasis visible on CT at the time of treatment initiation should undergo complete response. In Study Subjects without visible metastasis on CT at the time of treatment, initiation should result in unchanged status on CT.

Data will be compared to available historical data on response to PD-1 / PD-L1 targeted agents.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Can VI-RADS/ADC Accurately Stage Bladder Cancer??	NCT04167631	MRI Contrast Me... Bladder Cancer Bladder Disease Bladder Neoplas... Bladder Urothel... Bladder Cancer ... Diagnoses Disea...	Multi-parametri...	18 Years -	Mansoura University
Treatment Of Metastatic Bladder Cancer at the Time Of Biochemical reLApse Following Radical Cystectomy	NCT04138628	Bladder Cancer Bladder Cancer,...	Atezolizumab	18 Years -	Aarhus University Hospital
Treatment Of Metastatic Bladder Cancer at the Time Of Biochemical reLApse Following Radical Cystectomy	NCT04138628	Bladder Cancer Bladder Cancer,...	Atezolizumab	18 Years -	Aarhus University Hospital

Spots Global Cancer Trial Database for muscle invasive bladder cancer (mibc)