PET/MRI and Biomarkers in Bladder Cancer

Study Overview
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Brief Summary
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Muscle invasive bladder cancer is an aggressive malignancy. Currently the investigators lack accurate imaging technologies in clinical staging and estimation of response to neoadjuvant chemotherapy as well as prognostic biomarkers. In the current study novel imaging modality (MRI/PET) is utilized to stage bladder cancer prior to transurethral resection of bladder-tumor and after neoadjuvant chemotherapy. Also prognostic biomarkers are studied from TUR-BT tissues, blood and urine to estimate response to neoadjuvant chemotherapy.

Official Title
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PET/MRI and Biomarkers in Clinical Staging of Bladder Cancer and in the Estimation of Neoadjuvant Chemotherapy Response Prior to Radical Cystectomy

Conditions
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Bladder Cancer

Intervention / Treatment
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* Device: MRI/acetate-PET imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: invasive or locally advanced bladder cancer based on cystoscopic evaluation Age: 18 to 85 years old Language spoken: Finnish or Swedish 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: Prior medical history: Patient must have no history of serious cardiovascular, liver or kidney disease Infections: Patient must not have an uncontrolled serious infection Contraindications for MRI (cardiac pacemaker, intracranial clips etc) Patient refusing radical cystectomy or chemotherapy Intravesical Bacillus Calmette-Guerin instillations within 6 months

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: MRI/PET<br> | Device: MRI/acetate-PET imaging<br> <br> * Other names: 11C-acetate as PET-tracer;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| staging accuracy of PET/MRI in bladder cancer | Accuracy of PET/MRI to stage newly diagnosed bladder cancer. MRI/PET staging results is compared to pathology report of TUR-BT and cystectomy specimens. | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Accuracy of PET/MRI to estimate response to neoadjuvant chemotherapy | Accuracy of PET/MRI to estimate response to neoadjuvant chemotherapy prior to radical cystectomy. MRI/PET results is compared to pathology report of cystectomy specimen. | 3 mo | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bladder cancer, neoadjuvant chemotherapy, radical cystectomy, lymphadenectomy, biomarker