- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT02662166
MRI in Clinical Staging and Estimation of Treatment Response in Bladder Cancer (MIB)
June 16, 2020 updated by: Peter Boström, Turku University Hospital
Magnetic Resonance Imaging of Bladder Cancer
Bladder cancer (BC) as the most common malignancy arising from the urinary tract continues to be a major health problem.
This prospective non-randomized study will enroll 150 patients undergoing magnetic resonance imaging (MRI) at different stages of their diagnostic and therapeutical process.
The enrolled patients with suspected BC (BC) based on cystoscopy will have their initial MRI examination before transurethral resection of bladder tumor (TUR-BT) and biomarker collection.
After pathology review of the histological specimens, patients will be treated according to standard clinical practice.
The second MRI examination will be performed before therapeutic intervention, if TUR-BT alone is not sufficient enough.
Neoadjuvant chemotherapy will be applied in high risk patients having muscle invasison, while intermediate risk patient - T1 high grade or carcinoma in situ patients - will be treated using Bacillus Calmette-Guerin (BCG) instilliations.
After the completion of the neoadjuvant chemotherapy or BCG treatment, the patients will undergo the third MRI examination.
Low risk patients will be followed by annual with MRI examination.
Study Overview
Study Type
Interventional
Enrollment (Actual)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
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-
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Pori, Finland
- Department of Urology, Central Hospital of Pori
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Turku, Finland, 20100
- University of Turku
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Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 85 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Age: 18 to 85 years old
- Suspected BC based on cystoscopical evaluation.
- Mental status: Patients must be able to understand the meaning of the study
- Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff
Exclusion Criteria:
- History of serious cardiovascular, liver or kidney disease
- Uncontrolled serious infection
- Contraindications for MRI (cardiac pacemaker, intracranial clips etc)
- Patient refusing radical cystectomy or chemotherapy or BCG
- Intravesical Bacillus Calmette-Guerin instillations within 6 months before the first MRI examination
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: MRI and biomarkers in bladder cancer
Utilization of MR-imaging and biomarkers to stage bladder cancer and in estimation of chemosensitivity
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3 T MRI of the urinary bladder
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Accuracy of the multiparametric MRI (anatomical MRI, DCE-MRI, DWI) in the staging of bladder cancer
Time Frame: 24 months
|
The accuracy of multiparametric MRI (anatomical MRI, DCE-MRI, DWI) in the staging of bladder cancer will be evaluated using transurethral resection of bladder tumor and cystectomy specimens
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24 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Prediction of response to neo-adjuvant chemotherapy and/or BCG treatment evaluated by multiparametric MRI (anatomical MRI, DCE-MRI, DWI)
Time Frame: 24 months
|
The aim is to evaluate predictive power of multiparametric MRI for estimation neo-adjuvant chemotherapy and/or BCG treatment response.
Multiparametric MRI will be performed before neo-adjuvant chemotherapy and/or BCG treatment and patients will be followed using standard clinical follow up and/or undergo cystectomy.
|
24 months
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Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Estimation of chemosensitivity
Time Frame: 24 months
|
Prevalence of patients responding neo-adjuvant chemotherapy, compared with the non-responders as evaluated by cystectomy specimens, according to various biomarkers and ex vivo tissue culturing will be evaluated.
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24 months
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Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Peter Boström, MD, PhD, Department of Urology, University of Turku and Turku University Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
July 1, 2014
Primary Completion (Actual)
July 10, 2019
Study Completion (Actual)
May 1, 2020
Study Registration Dates
First Submitted
January 5, 2015
First Submitted That Met QC Criteria
January 19, 2016
First Posted (Estimate)
January 25, 2016
Study Record Updates
Last Update Posted (Actual)
June 17, 2020
Last Update Submitted That Met QC Criteria
June 16, 2020
Last Verified
June 1, 2020
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 6/1801/2014
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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