Trials / Completed
CompletedNCT01655745
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
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 22 (actual)
- Sponsor
- UNC Lineberger Comprehensive Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
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.
Detailed description
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. All patients will undergo baseline FDG-PET-MRI and routine (standard of care) contrast enhanced abdominal/pelvic multi-detector computed tomography (MDCT). The imaging results will ultimately be compared to final pathology as the gold standard. If the accuracy of FDG-PET-MRI is improved as compared to standard MDCT, the investigators plan to conduct a larger follow-up study to confirm the results of this pilot study. In addition, this pilot study will set the stage for the evaluation of novel PET tracers in the imaging of bladder cancer.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | FDG PET/MR | All patients will undergo a gadolinium enhanced MRI with simultaneous acquisition of FDG-PET prior to planned radical cystectomy and pelvic lymph node dissection |
Timeline
- Start date
- 2012-07-24
- Primary completion
- 2016-12-01
- Completion
- 2019-02-01
- First posted
- 2012-08-02
- Last updated
- 2019-10-31
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT01655745. Inclusion in this directory is not an endorsement.