Clinical trial · Interventional
Bladder Fiducial Markers and Multiparametric-MRI (Mp-MRI) to Optimize Bladder Chemo-radiotherapy
NCT04442724CI-TRIAL-00093654FMBRTrecruitingN/AClinicalTrials.gov clinicaltrialsProvenance
- 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)
The purpose of this study is to examine the usefulness of implanting small 24-K gold fiducial markers around a bladder tumor site, so that a Radiation Oncologist can identify the original tumor location at the time of radiation treatment. Other goals of the study include assessing whether a new MRI imaging technology can help with detection of bladder cancer earlier and more accurately when evidence of bladder cancer is not visible by scope.
Conditions
Conditions (5)
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 |
| Neoplasms | Neoplasm | ONTOLOGY_EXACT | 0.90 |
| Urinary Bladder Diseases | — | UNRESOLVED | — |
| Urinary Bladder Neoplasm | Bladder Neoplasm | ALIAS | 0.90 |
| Urologic Neoplasms | Urinary Tract Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Fiducial marker placement | Procedure | — | UNRESOLVED |
| Multiparametric MRI (mpMRI) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Single Arm - Bladder Chemo-Radiotherapy
- description
- Fiducial marker placement \& cystogram during resection surgery, followed by radiation planning CT scan, mpMRI, chemo-radiation treatment; mpMRI and/or surveillance cystoscopy at 3, 6, and 9 months post-treatment.
- interventionNames
- Procedure: Fiducial marker placement
- Diagnostic Test: Multiparametric MRI (mpMRI)
Primary outcomes (1)
- measure
- Bladder volume differential
- timeFrame
- Baseline, after marker placement (anticipated to occur between study days 0-1)
- description
- Change in bladder volumes targeted for high dose radiation (HDR) between the first (Baseline) dose volume histogram (DVH) without the fiducial markers present, compared to the second DVH made after placement of the fiducial markers
Secondary outcomes (3)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Pathologically (histologically or cytologically) proven diagnosis of primary urothelial carcinoma of the bladder. Subjects with mixed histology are required to have a dominant traditional cell carcinoma (TCC) pattern. * Clinical stage T2-T4a, Nx, M0 considered appropriate for, and electing to receive, chemoradiation of the bladder * Planned TURBT as part of the normal course treatment, to take place prior to the initiation of chemo irradiation * Adequate renal function: Serum creatinine \< 2 mg/dL OR calculated creatinine clearance (CrCl) \> 30ml/min * Ability to understand and willingness to sign a written informed consent * Women of child-bearing potential and men must agree to use adequate contraception prior to study entry, during study participation, and for 90 days after study treatment discontinuation * Should a woman become pregnant or suspect she is pregnant while she or her partner is participating in this study, she should inform her treating physician immediately Exclusion Criteria: * Subjects with primary TCC of the ureter, urethra, or renal pelvis, without TCC of the bladder, are not allowed * Known distant metastatic disease (e.g. pulmonary or hepatic metastases) * Subjects with malignant lymphadenopathy in the abdomen or pelvis considered appropriate for radical cystectomy and lymphadenectomy with the goal of complete resection of all malignant disease are allowed * Patients with bladder abnormalities that preclude safe placement of fiducial markers (i.e. abundant large diverticuli or cellules, active or recurrent urinary infection) * Planned (or prior history of) definitive bladder irradiation * Intravesical chemo- or biologic therapy within 6 weeks of first treatment * Any planned neoadjuvant systemic immunotherapy. Note that prior bacille Calmette-Guerin vaccine (BCG) is not an exclusion * Clinically significant active infection or uncontrolled medical condition that would preclude participation in study * Pregnant or nursing women are excluded * Previous malignancy other than TCC that, in the opinion of the treating investigator, is likely to interfere with protocol treatment * Individuals with severe renal failure and cannot receive MRI contrast
References
Publications (0)
Data not yet available
No reference posted for this study.