Trial Title:
Multi-parametric MRI in Patients Suspected for Muscle Invasive Bladder Cancer: a New Local Staging Paradigm
NCT ID:
NCT05779631
Condition:
Bladder Cancer
Conditions: Official terms:
Urinary Bladder Neoplasms
Conditions: Keywords:
mpMRI + same-day biopsy
TURBT
Study type:
Interventional
Study phase:
N/A
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Intervention model description:
TURBT versus mpMRI plus a same-day cystoscopic bladder biopsy
Primary purpose:
Diagnostic
Masking:
None (Open Label)
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
mpMRI plus a same-day cystoscopic bladder biopsy
Description:
mpMRI plus a same-day cystoscopic bladder biopsy
Arm group label:
mpMRI plus a same-day cystoscopic bladder biopsy
Intervention type:
Procedure
Intervention name:
TURBT
Description:
Transurethral resection of the bladder tumor
Arm group label:
TURBT
Summary:
A two-arm multicenter randomised controlled trial, comparing progression free survival,
time to definitive treatment and cost-effectiveness of the standard of care (TURBT) and
mpMRI followed by same-day cystoscopic bladder biopsy for diagnosis of patients with
suspicion of muscle-invasive bladder cancer.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
- Patients (18+ years of age) with clinically suspected MIBC, without lymph node or
distant metastases, written informed consent
Exclusion Criteria:
- Unable or unwilling to undergo mpMRI
- Unfit for TURBT
- Unfit for definitive treatment with curative intent
- A history of cancer, including bladder cancer, except non-melanoma skin cancer or
prostate cancer on active surveillance
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Ziekenhuisgroep Twente
Address:
City:
Almelo
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Amsterdam UMC, location AMC
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Amsterdam UMC, location VUmc
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Antoni van Leeuwenhoek - Netherlands Cancer Institute
Address:
City:
Amsterdam
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Rijnstate ziekenhuis
Address:
City:
Arnhem
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Maasziekenhuis Pantein
Address:
City:
Boxmeer
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Jeroen Bosch ziekenhuis
Address:
City:
Den Bosch
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Ziekenhuis Gelderse Vallei
Address:
City:
Ede
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
St. Antonius ziekenhuis
Address:
City:
Nieuwegein
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Canisius Wilhelmina Ziekenhuis
Address:
City:
Nijmegen
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Radboud university medical center
Address:
City:
Nijmegen
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
Erasmus Medical Center
Address:
City:
Rotterdam
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
Bernhoven ziekenhuis
Address:
City:
Uden
Country:
Netherlands
Status:
Recruiting
Facility:
Name:
University Medical Center Utrecht
Address:
City:
Utrecht
Country:
Netherlands
Status:
Not yet recruiting
Facility:
Name:
VieCuri medisch centrum
Address:
City:
Venlo
Country:
Netherlands
Status:
Not yet recruiting
Start date:
December 6, 2023
Completion date:
December 2028
Lead sponsor:
Agency:
Radboud University Medical Center
Agency class:
Other
Source:
Radboud University Medical Center
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05779631
