LCCC 1209: Pilot Study of [18F] Fluorodeoxyglucose Positron Emission Tomography-Magnetic Resonance Imaging (FDG-PET-MRI) for Staging of Muscle-Invasive Bladder Cancer
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.
Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Sensitivity and specificity of the FDG-PET-MRI for staging of muscle-invasive bladder cancer
The sensitivity and specificity of the FDG-PET-MRI for staging of muscle-invasive bladder will be evaluated by using the pathology from the radical cystectomy and lymph node dissection specimen or biopsy as the reference standard. The sensitivity and specificity of FDG-PET-MRI will be compared to conventional CT performed in all patients in this pilot study and FDG-PET-CT.
Matthew I. Milowsky, MD
University of North Carolina
United States: Institutional Review Board
|Lineberger Comprehensive Cancer Center||Chapel Hill, North Carolina 27599-7305|