Nashville, Tennessee 37232


Purpose:

This clinical trial studies fluorine F 18 L-glutamate derivative BAY94-9392 (18F-FSPG) positron emission tomography (PET) in imaging patients with liver cancer before undergoing surgery or transplant. Diagnostic procedures, such as 18F-FSPG PET, may help find and diagnose liver cancer and find out how far the disease has spread.


Study summary:

PRIMARY OBJECTIVES: I. To evaluate the relationship between 18F-FSPG PET/computed tomography (CT) and pathology in patients with suspected hepatocellular carcinoma (HCC) scheduled for liver resection surgery and orthotopic liver transplant (OLT). II. To compare 18F-FSPG PET/CT with standard-of-care (SOC) diagnostic CT imaging in patients with suspected HCC scheduled for liver resection surgery or OLT. III. To compare the uptake of 18F-FSPG PET/CT with 11C-acetate PET/CT in suspected HCC and background liver in patients scheduled for liver resection surgery or OLT. IV. To evaluate uptake of 18F-FSPG PET/CT in non-HCC liver tumors: benign and malignant compared to background. OUTLINE: Patients undergo 18F-FSPG PET and carbon-11 (11C)-acetate PET scans within 4-8 weeks of surgery or OLT.


Criteria:

Inclusion Criteria: - Diagnosis of HCC with clinically documented cirrhosis and one or more of the following: - Liver mass (>= 1 cm) with arterial phase contrast enhancement and early washout on subsequent phases by CT; or - Suggestive imaging findings plus alpha-feto protein (AFP) > 200 mg/dL; or - Tumor confirmed by arteriography -or- - Diagnosis of a non-HCC liver mass with one or more of the following: - Liver mass (≥ 1 cm) that has suggestive imaging findings of a benign liver mass (adenoma, hemangioma, focal nodular hyperplasia). - Liver mass (≥ 1 cm) that is biopsy proven metastatic disease (metastatic colorectal cancer, metastatic pancreatic cancer). - Liver mass (≥ 1 cm) that is a non-HCC primary malignancy (cholangiocarcinoma). -and- - Each patient must provide written informed consent and have completed conventional imaging and staging and CT (multiphase) or MRI before initiation of the investigational PET studies Exclusion Criteria: - Patients with a known prior malignancy who have received systemic chemotherapy within five years, except basal cell carcinoma of the skin, carcinoma in situ of the cervix, prior HCC, and patients with liver mass(es) proven to be metastatic disease are excluded. - Pregnant and breastfeeding patients - Patients with poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL) - Patients with a known infiltrative variant of HCC


NCT ID:

NCT02379377


Primary Contact:

Principal Investigator
Sunil Geevarghese, MD
Vanderbilt-Ingram Cancer Center

VICC Clinical Trials Information Program
Phone: 800-811-8480


Backup Contact:

Allison Cohen, PhD
Phone: 615.323.8392


Location Contact:

Nashville, Tennessee 37232
United States

Allison Cohen, PhD
Phone: 615-323-8392
Email: allison.s.cohen@vanderbilt.edu

Site Status: Recruiting


Data Source: ClinicalTrials.gov

Date Processed: March 16, 2018

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