PET/MRI and Biomarkers in Clinical Staging of Bladder Cancer and in the Estimation of Neoadjuvant Chemotherapy Response Prior to Radical Cystectomy
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Bladder Cancer
- Sponsor
- Turku University Hospital
- Enrollment
- 25
- Locations
- 3
- Primary Endpoint
- staging accuracy of PET/MRI in bladder cancer
- Status
- Completed
- Last Updated
- 8 years ago
Overview
Brief Summary
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.
Investigators
Peter Boström
chief, department of urology
Turku University Hospital
Eligibility Criteria
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
Outcomes
Primary Outcomes
staging accuracy of PET/MRI in bladder cancer
Time Frame: 3 months
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.
Secondary Outcomes
- Accuracy of PET/MRI to estimate response to neoadjuvant chemotherapy(3 mo)