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

Not Applicable

Recruiting

• Conditions: Bladder Cancer
• Interventions: Diagnostic Test: MRI Sequences

• Registration Number: NCT04533672
• Lead Sponsor: University of Zurich

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-08-23
• Study First Submitted QC: 2020-08-26
• Study First Posted: 2020-08-31
• Study Start: 2021-02-01
• Status Verified: 2024-12
• Last Update Submitted: 2024-12-03
• Last Update Posted: 2024-12-06
• Primary Completion: 2026-02-01
• Study Completion: 2026-10-01

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 182

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).

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Single study arm	MRI Sequences	-

Primary Outcome Measures

Name	Time	Method
Muscle-invasiveness	through study completion, an average of 4 years	Presence of tumor infiltration into the muscular bladder wall, as per pathology report (infiltration: yes/no)

Trial Locations

Locations (1)

University Hospital Zurich; 🇨🇭 Zurich, ZH, Switzerland