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

Bladder Cancer Clinical Trial

— MIB  

Official title:

Magnetic Resonance Imaging of Bladder Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02662166
• Other study ID #: 6/1801/2014
• Status: Completed
• Phase: N/A
• Start date: July 2014
• Est. completion date: May 1, 2020

Study information

• Verified date: June 2020
• Source: Turku University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 1, 2020
• Est. primary completion date: July 10, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

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

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Device:
• MR imaging
3 T MRI of the urinary bladder

Locations

Country	Name	City	State
Finland	Department of Urology, Central Hospital of Pori	Pori
Finland	University of Turku	Turku

Sponsors (1)

Lead Sponsor	Collaborator
Turku University Hospital

Country where clinical trial is conducted

Finland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Estimation of chemosensitivity	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.	24 months
Primary	Accuracy of the multiparametric MRI (anatomical MRI, DCE-MRI, DWI) in the staging of bladder cancer	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	24 months
Secondary	Prediction of response to neo-adjuvant chemotherapy and/or BCG treatment evaluated by multiparametric MRI (anatomical MRI, DCE-MRI, DWI)	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.	24 months