Bladder Cancer Clinical Trial
— ACEBIBOfficial title:
PET/MRI and Biomarkers in Clinical Staging of Bladder Cancer and in the Estimation of Neoadjuvant Chemotherapy Response Prior to Radical Cystectomy
Verified date | April 2018 |
Source | Turku University Hospital |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 25 |
Est. completion date | November 2016 |
Est. primary completion date | March 2016 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 18 Years to 85 Years |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
Finland | Helsinki University Hospital | Helsinki | |
Finland | Tampere University Hospital | Tampere | |
Finland | Turku University Hospital | Turku |
Lead Sponsor | Collaborator |
---|---|
Turku University Hospital |
Finland,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Accuracy of prognostic biomarkers to estimate response to neoadjuvant chemotherapy. | Accuracy of tissue, blood and urine based biomarkers to estimate response to neoadjuvant chemotherapy is estimated | 6 mo | |
Primary | 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 | 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 |
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