The IMAGE1 S* Non-Muscle-Invasive bladder cancer study: A multicenter international randomized controlled study to compare the outcome using the IMAGE1 S* System versus White Light Imaging (WLI) during TURB of Non-Muscle-Invasive Bladder Cancer (NMIBC).

Phase 3

Completed

• Conditions: bladder cancer; 10004994; 10038365

• Registration Number: NL-OMON47283
• Lead Sponsor: Academisch Medisch Centrum

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Last Update Posted: 23 April 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 100

Inclusion Criteria

Patients scheduled for treatment of a primary or recurrent NMIBC
Patients aged 18 years or older
Has or has had no tumors in the upper urinary tract
Has had no previous irradiation of the pelvis

Exclusion Criteria

Gross haematuria at the time of TURB (i.e. heavy bladder bleeding resulting in marked amounts of blood in the urine which may interfere with cystoscopy)
Pregnancy or breast-feeding (all women of child-bearing potential must document a negative serum or urine pregnancy test at screening and are suggested to use the contraceptive pill or an intrauterine device (IUD) during the treatments and for at least one months thereafter)
Has had instillation therapy in the six months prior to the screening visit

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
<p>Comparison of the proportions of Arm A and Arm B subjects that have a<br /><br>histologically confirmed recurrence found at either three months, one year and<br /><br>three years after TURB. </p><br>

Secondary Outcome Measures

Name	Time	Method
<p>Peri-operative morbidity (30 days) assessed by the Clavien-Dindo score<br /><br>Proportion of re-TUR (defined as within 3 months of initial TURB: this can be a<br /><br>planned TURBT because of resection of high risk tumor, or because of recurrent<br /><br>tumor confirmed at cystoscopy at three months)<br /><br>Baseline characteristics of the patients, such as age or BMI<br /><br>Comorbidities, such as Diabetes Mellitus or cardiovascular disease<br /><br>Risk factors, such as smoking and use of anticoagulation<br /><br>When appropriate: information on previous (adjuvant) treatment, such as type<br /><br>and date of most recent treatment and re-TURs</p><br>