Clinical trial · Interventional
MRI in Clinical Staging and Estimation of Treatment Response in Bladder Cancer
Magnetic Resonance Imaging of Bladder Cancer
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Bladder cancer (BC) as the most common malignancy arising from the urinary tract continues to be a major health problem. This prospective non-randomized study will enroll 150 patients undergoing magnetic resonance imaging (MRI) at different stages of their diagnostic and therapeutical process. The enrolled patients with suspected BC (BC) based on cystoscopy will have their initial MRI examination before transurethral resection of bladder tumor (TUR-BT) and biomarker collection. After pathology review of the histological specimens, patients will be treated according to standard clinical practice. The second MRI examination will be performed before therapeutic intervention, if TUR-BT alone is not sufficient enough. Neoadjuvant chemotherapy will be applied in high risk patients having muscle invasison, while intermediate risk patient - T1 high grade or carcinoma in situ patients - will be treated using Bacillus Calmette-Guerin (BCG) instilliations. After the completion of the neoadjuvant chemotherapy or BCG treatment, the patients will undergo the third MRI examination. Low risk patients will be followed by annual with MRI examination.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Bladder Cancer | Malignant Bladder Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| MR imaging | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- MRI and biomarkers in bladder cancer
- description
- Utilization of MR-imaging and biomarkers to stage bladder cancer and in estimation of chemosensitivity
- interventionNames
- Device: MR imaging
Primary outcomes (1)
- measure
- Accuracy of the multiparametric MRI (anatomical MRI, DCE-MRI, DWI) in the staging of bladder cancer
- timeFrame
- 24 months
- description
- The accuracy of multiparametric MRI (anatomical MRI, DCE-MRI, DWI) in the staging of bladder cancer will be evaluated using transurethral resection of bladder tumor and cystectomy specimens
Secondary outcomes (1)
- measure
- Prediction of response to neo-adjuvant chemotherapy and/or BCG treatment evaluated by multiparametric MRI (anatomical MRI, DCE-MRI, DWI)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
Inclusion Criteria: * Age: 18 to 85 years old * Suspected BC based on cystoscopical evaluation. * Mental status: Patients must be able to understand the meaning of the study * Informed consent: The patient must sign the appropriate Ethical Committee (EC) approved informed consent documents in the presence of the designated staff Exclusion Criteria: * History of serious cardiovascular, liver or kidney disease * Uncontrolled serious infection * Contraindications for MRI (cardiac pacemaker, intracranial clips etc) * Patient refusing radical cystectomy or chemotherapy or BCG * Intravesical Bacillus Calmette-Guerin instillations within 6 months before the first MRI examination
References
Publications (1)
- DERIVEDNikulainen I, Salminen AP, Jambor I, Merisaari H, Tammilehto V, Taimen P, Seikkula H, Bostrom PJ. Visual MRI T-category versus VI-RADS evaluation from multiparametric MRI in the detection of muscle-invasion in patients with suspected bladder cancer: single centre registered clinical trial (MIB-trial). Scand J Urol. 2021 Oct;55(5):354-360. doi: 10.1080/21681805.2021.1971290. Epub 2021 Aug 27. PMID 34448679