Replacement of a surgical procedure called transurethral resection of bladder tumour with a painless imaging procedure called magnetic resonance imaging in patients with muscle invasive bladder cancer

Not Applicable

• Conditions: Bladder cancer; Cancer; Malignant neoplasm of bladder

• Registration Number: ISRCTN35296862
• Lead Sponsor: niversity of Birmingham

Brief Summary

2021 Interim results article in https://doi.org/10.1016/j.eururo.2021.02.021 (added 18/10/2021)

Detailed Description

Not available

Study Timeline

• Study Start: 2016-11-14
• Last Update Posted: 29 July 2024
• Study Completion: 2024-11-30

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 143

Inclusion Criteria

1. Provision of written informed consent
2. =18 years of age
3. Patients attending haematuria clinic for the investigation of symptoms suspicious of bladder cancer (initial consent process)
4. Patients given a diagnosis of suspected bladder cancer and requiring a TURBT based on visual cystoscopic examination of the bladder (confirmatory consent process, post cystoscopy)
Note: as the study does not involve additional drug therapy or ionising radiation, there are no restrictions on women of childbearing potential

Exclusion Criteria

1. Patients unable or unwilling to undergo MRI. Criteria include but is not exclusive of the presence of foreign bodies or pacemakers, claustrophobia, adverse reactions to MRI contrast media and eGFR of less than 40 ml/min/1.73m2
2. Patients who are pregnant or breastfeeding
3. Previous diagnosis of bladder cancer
4. Previous entry into the present trial
5. Patients not suitable/fit for radical treatment
Note: The study does not include upper age related exclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
1. Feasibility stage: the proportion of possible MIBC patients randomised to pathway 2 who correctly follow the pathway protocol, measured after 150 patients have been entered into the study and completed pathway 2<br>2. Intermediate stage: the time to definitive treatment (TTDT) for all possible MIBC patients<br>3. Final clinical stage: clinical progression-free survival (CPFS), assessed after 2 years follow-up - updated 26/07/2022: NOT DONE (recruitment closed after the Feasibility/Intermediate stages)