Bladder Cancer
Conditions
Keywords
bladder cancer, MRI, TUR-BT, cystectomy, chemotherapy
Brief summary
Bladder cancer (BC) as the most common malignancy arising from the urinary tract continues to be a major health problem. This prospective non-randomized study will enroll 150 patients undergoing magnetic resonance imaging (MRI) at different stages of their diagnostic and therapeutical process. The enrolled patients with suspected BC (BC) based on cystoscopy will have their initial MRI examination before transurethral resection of bladder tumor (TUR-BT) and biomarker collection. After pathology review of the histological specimens, patients will be treated according to standard clinical practice. The second MRI examination will be performed before therapeutic intervention, if TUR-BT alone is not sufficient enough. Neoadjuvant chemotherapy will be applied in high risk patients having muscle invasison, while intermediate risk patient - T1 high grade or carcinoma in situ patients - will be treated using Bacillus Calmette-Guerin (BCG) instilliations. After the completion of the neoadjuvant chemotherapy or BCG treatment, the patients will undergo the third MRI examination. Low risk patients will be followed by annual with MRI examination.
Interventions
DEVICEMR imaging
3 T MRI of the urinary bladder
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
* Age: 18 to 85 years old * Suspected BC based on cystoscopical evaluation. * 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
* History of serious cardiovascular, liver or kidney disease * Uncontrolled serious infection * Contraindications for MRI (cardiac pacemaker, intracranial clips etc) * Patient refusing radical cystectomy or chemotherapy or BCG * Intravesical Bacillus Calmette-Guerin instillations within 6 months before the first MRI examination
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Accuracy of the multiparametric MRI (anatomical MRI, DCE-MRI, DWI) in the staging of bladder cancer | 24 months | The accuracy of multiparametric MRI (anatomical MRI, DCE-MRI, DWI) in the staging of bladder cancer will be evaluated using transurethral resection of bladder tumor and cystectomy specimens |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Prediction of response to neo-adjuvant chemotherapy and/or BCG treatment evaluated by multiparametric MRI (anatomical MRI, DCE-MRI, DWI) | 24 months | The aim is to evaluate predictive power of multiparametric MRI for estimation neo-adjuvant chemotherapy and/or BCG treatment response. Multiparametric MRI will be performed before neo-adjuvant chemotherapy and/or BCG treatment and patients will be followed using standard clinical follow up and/or undergo cystectomy. |
Other
| Measure | Time frame | Description |
|---|---|---|
| Estimation of chemosensitivity | 24 months | Prevalence of patients responding neo-adjuvant chemotherapy, compared with the non-responders as evaluated by cystectomy specimens, according to various biomarkers and ex vivo tissue culturing will be evaluated. |
Countries
Finland
Outcome results
None listed