PET/MRI and Biomarkers in Bladder Cancer (ACEBIB)
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.
|Study Design:||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||PET/MRI and Biomarkers in Clinical Staging of Bladder Cancer and in the Estimation of Neoadjuvant Chemotherapy Response Prior to Radical Cystectomy|
- staging accuracy of PET/MRI in bladder cancer [ Time Frame: 3 months ] [ Designated as safety issue: No ]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.
- Accuracy of PET/MRI to estimate response to neoadjuvant chemotherapy [ Time Frame: 3 mo ] [ Designated as safety issue: No ]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.
- Accuracy of prognostic biomarkers to estimate response to neoadjuvant chemotherapy. [ Time Frame: 6 mo ] [ Designated as safety issue: No ]Accuracy of tissue, blood and urine based biomarkers to estimate response to neoadjuvant chemotherapy is estimated
|Study Start Date:||August 2013|
|Estimated Study Completion Date:||November 2016|
|Estimated Primary Completion Date:||March 2016 (Final data collection date for primary outcome measure)|
Device: MRI/acetate-PET imaging
Please refer to this study by its ClinicalTrials.gov identifier: NCT01918592
|Contact: Peter J. Bostrom, MD, PhDfirstname.lastname@example.org|
|Helsinki University Hospital||Recruiting|
|Contact: Ilmari Koskinen, MD email@example.com|
|Principal Investigator: Ilmari Koskinen, MD|
|Tampere University Hospital||Recruiting|
|Contact: Andres Kotsar, MD firstname.lastname@example.org|
|Principal Investigator: Andres Kotsar, MD|
|Turku University Hospital||Recruiting|
|Turku, Finland, 20100|
|Contact: Peter Bostrom, MD|
|Principal Investigator: Peter Bostrom, MD|