Clinical trial · Interventional
Positron Emission Tomography (PET) Study for Staging of Muscle Invasive Bladder Cancer
LCCC 1209: Pilot Study of [18F] Fluorodeoxyglucose Positron Emission Tomography-Magnetic Resonance Imaging (FDG-PET-MRI) for Staging of Muscle-Invasive 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)
This prospective pilot study will enroll 30 patients with cT2/T3-N0-M0 urothelial carcinoma of the bladder for whom radical cystectomy with pelvic lymph node dissection is planned. This pilot study is designed to provide preliminary information on the accuracy of \[18F\] Fluorodeoxyglucose Positron Emission Tomography MRI (FDG-PET-MRI) in the staging of muscle-invasive bladder cancer.
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 |
|---|---|---|---|
| FDG PET/MR | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- FDG PET/MR, No Chemotherapy Arm
- description
- Patients that are NOT receiving chemotherapy but are only completing surgical intervention.
- interventionNames
- Procedure: FDG PET/MR
- type
- EXPERIMENTAL
- label
- FDG PET/MR, Chemotherapy Arm
- description
- Patients that are receiving chemotherapy prior to completing surgical intervention. These patients will receive a FDG PET/MR prior to chemotherapy and after completion of chemotherapy (at the time of pre-op, before surgical intervention).
- interventionNames
- Procedure: FDG PET/MR
Primary outcomes (1)
- measure
- Sensitivity and specificity of the FDG-PET-MRI for staging of muscle-invasive bladder cancer
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * ≥ 18 years of age (no upper age limit) * Informed consent obtained and signed * cT2/T3-N0-M0 urothelial carcinoma of the bladder * Planned radical cystectomy with pelvic lymph node dissection * No known local regional or distant metastatic disease * Women of childbearing potential must have a negative serum or urine pregnancy test performed within 7 days prior to FDG-PET-MRI Exclusion Criteria: * History of severe reaction to contrast-enhanced CT scan * Poorly controlled diabetes mellitus * Inability to tolerate PET and/or MRI * Presence of pacemaker or intracranial aneurysm clip * Serum creatinine \>1.8 mg/dL OR GFR \< 30mL/min * Pregnant or lactating female * Inability to lie flat for \>1 hour * Body Mass Index (BMI) \>35 * History of a prior malignancy within past 5 years are excluded unless they have been disease free for 3 or more years or unless they have a completely resected non-melanoma skin cancer. * Substance abuse, medical, psychological, or social conditions that may interfere with the patient's participation in the study
References
Publications (0)
Data not yet available