MIB: MRI in Clinical Staging and Estimation of Treatment Response in Bladder Cancer

Sponsor

Turku University Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02662166

Collaborator

(none)

Enrollment

Locations

Arm

Actual Duration (Months)

Patients Per Site

0.4

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Bladder Cancer	Device: MR imaging	N/A

Study Design

Study Type:

Interventional

Actual Enrollment :

50 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Diagnostic

Official Title:

Magnetic Resonance Imaging of Bladder Cancer

Actual Study Start Date :

Jul 1, 2014

Actual Primary Completion Date :

Jul 10, 2019

Actual Study Completion Date :

May 1, 2020

Arms and Interventions

Arm	Intervention/Treatment
Experimental: MRI and biomarkers in bladder cancer Utilization of MR-imaging and biomarkers to stage bladder cancer and in estimation of chemosensitivity	Device: MR imaging 3 T MRI of the urinary bladder

Arm

Intervention/Treatment

Experimental: MRI and biomarkers in bladder cancer

Utilization of MR-imaging and biomarkers to stage bladder cancer and in estimation of chemosensitivity

Device: MR imaging

3 T MRI of the urinary bladder

Outcome Measures

Primary Outcome Measures

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 Outcome Measures

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 Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 85 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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