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

Bladder Cancer Clinical Trial

— SBCT  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT04533672
• Other study ID #: SBCT
• Status: Recruiting
• Phase: N/A
• Start date: February 1, 2021
• Est. completion date: October 1, 2025

Study information

• Verified date: November 2023
• Source: University of Zurich
• Contact: Andreas Hötker, MD
• Phone: +41 44 255 29 20
• Email: andreas.hoetker[@]usz.ch
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 182
• Est. completion date: October 1, 2025
• Est. primary completion date: February 1, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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).

Related Conditions & MeSH terms

• Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Diagnostic Test:
• MRI Sequences
New multiparametric MRI techniques

Locations

Country	Name	City	State
Switzerland	University Hospital Zurich	Zurich	ZH

Sponsors (2)

Lead Sponsor	Collaborator
University of Zurich	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Muscle-invasiveness	Presence of tumor infiltration into the muscular bladder wall, as per pathology report (infiltration: yes/no)	through study completion, an average of 4 years