Positron Emission Tomography (PET) Study for Staging of Muscle Invasive Bladder Cancer

UNC Lineberger Comprehensive Cancer Center

Status: Completed

Conditions: Bladder Cancer

Treatments: Procedure: FDG PET/MR

Study type: Interventional

Funder types: Other

Identifiers

NCT01655745

LCCC 1209

Details and patient eligibility

About

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.

Full 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.

Enrollment: 22 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: Non-Randomized

Interventional model: Single Group Assignment

Masking: None (Open label)

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22 participants in 2 patient groups

FDG PET/MR, No Chemotherapy Arm

Experimental group

Description:

Patients that are NOT receiving chemotherapy but are only completing surgical intervention.

Treatment:

Procedure: FDG PET/MR

FDG PET/MR, Chemotherapy Arm

Experimental group

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).

Treatment:

Procedure: FDG PET/MR