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

Not Applicable

Completed

• Conditions: Bladder Cancer
• Interventions: Device: MR imaging

• Registration Number: NCT02662166
• Lead Sponsor: Turku University Hospital

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2014-07
• Study First Submitted: 2015-01-05
• Study First Submitted QC: 2016-01-19
• Study First Posted: 2016-01-25
• Primary Completion: 2019-07-10
• Study Completion: 2020-05-01
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-16
• Last Update Posted: 2020-06-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
MRI and biomarkers in bladder cancer	MR imaging	Utilization of MR-imaging and biomarkers to stage bladder cancer and in estimation of chemosensitivity

Primary Outcome Measures

Name	Time	Method
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

Name	Time	Method
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.

Trial Locations

Locations (2)

Department of Urology, Central Hospital of Pori; 🇫🇮 Pori, Finland

University of Turku; 🇫🇮 Turku, Finland