Clinical trial NCT01655745: Positron Emission Tomography (PET) Study for Staging of Muscle Invasive Bladder Cancer
Official title: LCCC 1209: Pilot Study of [18F] Fluorodeoxyglucose Positron Emission Tomography-Magnetic Resonance Imaging (FDG-PET-MRI) for Staging of Muscle-Invasive Bladder Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Bladder Cancer
Keywords: [18F]
FDG Positron Emission Tomography-Magnetic Resonance Imaging
FDG-PET-MRI
Muscle-Invasive Bladder Cancer
Pilot Study
LCCC 1209
UNC Lineberger
MDCT
Lead sponsor: UNC Lineberger Comprehensive Cancer Center
Sponsor class: OTHER
First posted: 2012-08-02
Enrollment: 22
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

Eligibility criteria: 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

Primary outcomes:
measure: Sensitivity and specificity of the FDG-PET-MRI for staging of muscle-invasive bladder cancer
timeFrame: 3 years
Secondary outcomes:
measure: Association of FDG-PET-MRI with RFS, DSS and OS in patients with muscle-invasive bladder cancer
timeFrame: 3 years
Other outcomes:
Locations:
city: Chapel Hill
country: United States
facility: Lineberger Comprehensive Cancer Center
state: North Carolina
Study officials:
affiliation: University of North Carolina
name: Matthew I. Milowsky, MD
role: PRINCIPAL_INVESTIGATOR
References: