Multiparametric Magnetic Resonance Imaging (MRI) to Improve Bladder Cancer Staging and Treatment Decision-making

NCT ID: NCT04533672

Last Updated: 2025-11-18

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 186 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2021-02-01
• Study Completion Date: 2025-10-01

Brief Summary

The therapeutic approach to bladder cancer is strongly dependent on tumor stage and grade. Patients with non-muscle-invasive tumors (NMIBC) are usually treated with surgical resection of the tumor alone, whereas patients with muscle-invasive tumors (MIBC) ideally undergo neoadjuvant chemotherapy (NCT) and subsequent cystectomy. Magnetic Resonance Imaging (MRI) is emerging as a new staging modality, given its non-invasiveness and excellent soft tissue contrast. However, more advanced multiparametric MRI techniques are yet to be comprehensively investigated in patients with bladder cancer. Recently, genetic characteristics of bladder tumors have been identified that show significant impact on response rates to neoadjuvant treatment. The combination of new multiparametric MRI (mpMRI) techniques and genetic analyses of the tumor might allow for a better assessment of the expected clinical course of the disease and support more personalized treatment approaches.

Conditions

Bladder Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Single study arm

Group Type: EXPERIMENTAL

MRI Sequences

Intervention Type: DIAGNOSTIC_TEST

New multiparametric MRI techniques

Interventions

MRI Sequences

New multiparametric MRI techniques

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

Inclusion Criteria

• Patients with confirmed or suspected primary bladder cancer and a circumscribed tumor/focal thickening of the bladder wall on initial imaging (ultrasound, CT) or cystoscopy with an approx. size of ≥ 1.5 cm/for which at least 2-3 TUR-B resection loops are necessary
• Informed consent as documented by signature (Informed Consent Form)

Exclusion Criteria

• Prior TUR-B or other bladder treatment, prior treated bladder cancers, prior pelvic irradiation
• Women who are pregnant or breast-feeding. Female participants who are surgically sterilized / hysterectomized or post-menopausal for longer than 2 years are not considered as being of childbearing potential.
• Inability to follow the procedures of the study, e.g. due to language problems, psychological disorders, dementia, etc. of the participant
• Previous enrolment into the current study
• Patients with non-MRI compatible metallic or electronic implants, devices or metallic foreign bodies (cardiac pacemaker, shrapnel, cochlea implants, neurostimulator, or other non-MRI compatible implants).

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Swiss National Science Foundation

OTHER

Sponsor Role: collaborator

University of Zurich

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

University Hospital Zurich

Zurich, Canton of Zurich, Switzerland

Countries

Switzerland

Other Identifiers

SBCT

Identifier Type: -

Identifier Source: org_study_id