Bladder Cancer
Conditions
Keywords
bladder cancer, neoadjuvant chemotherapy, radical cystectomy, lymphadenectomy, biomarker
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.
Interventions
DEVICEMRI/acetate-PET imaging
Sponsors
Turku University Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| staging accuracy of PET/MRI in bladder cancer | 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
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of PET/MRI to estimate response to neoadjuvant chemotherapy | 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. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of prognostic biomarkers to estimate response to neoadjuvant chemotherapy. | 6 mo | Accuracy of tissue, blood and urine based biomarkers to estimate response to neoadjuvant chemotherapy is estimated |
Countries
Finland
Outcome results
None listed