PET/MRI and Biomarkers in Bladder Cancer (ACEBIB)
|ClinicalTrials.gov Identifier: NCT01918592|
Recruitment Status : Completed
First Posted : August 8, 2013
Last Update Posted : April 18, 2018
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.
|Condition or disease||Intervention/treatment||Phase|
|Bladder Cancer||Device: MRI/acetate-PET imaging||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||PET/MRI and Biomarkers in Clinical Staging of Bladder Cancer and in the Estimation of Neoadjuvant Chemotherapy Response Prior to Radical Cystectomy|
|Study Start Date :||August 2013|
|Actual Primary Completion Date :||March 2016|
|Actual Study Completion Date :||November 2016|
Device: MRI/acetate-PET imaging
- 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.
- Accuracy of PET/MRI to estimate response to neoadjuvant chemotherapy [ Time Frame: 3 mo ]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 ]Accuracy of tissue, blood and urine based biomarkers to estimate response to neoadjuvant chemotherapy is estimated
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01918592
|Helsinki University Hospital|
|Tampere University Hospital|
|Turku University Hospital|
|Turku, Finland, 20100|