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

Completed · Not applicable

Conditions studied: Bladder Cancer

In brief

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.

Key facts

Study ID

NCT01655745

Run by

UNC Lineberger Comprehensive Cancer Center

People needed

22

Starts

2012-07-24

Expected to finish

2019-02-01

Last updated by the study team

2019-10-31

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• ≥ 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

You may not qualify if…

• 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

Where it is running

• Lineberger Comprehensive Cancer Center — Chapel Hill, North Carolina, United States

Full record on ClinicalTrials.gov

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