18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant

Phase 1Active Not RecruitingNCT02379377

M.D. Anderson Cancer Center110 enrolled

Overview

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.

PRIMARY OBJECTIVES: I. To evaluate the relationship between 18F-FSPG PET/computed tomography (CT), pathology, and cancer metabolism 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 MRI 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 AND 18F-FDG 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 benign liver lesions compared to background. V. To evaluate uptake of 18F-FSPG PET/CT in malignant non-HCC liver tumors. OUTLINE: Patients undergo 18F-FSPG PET and either carbon-11 (11C)-acetate PET or 18F-FDG PET scans within 4 weeks of surgery or OLT.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

110

Conditions

Adult Hepatocellular Carcinoma

Interventions

Fluorine F 18 L-glutamate Derivative 18F-FSPGBIOLOGICAL

Undergo 18F-FSPG PET scan

Carbon C 11 AcetateBIOLOGICAL

Undergo 11C-acetate PET scan

Positron Emission TomographyPROCEDURE

Undergo 18F-FSPG, 11C-acetate, or 18F-FDG PET

Laboratory Biomarker AnalysisOTHER

Correlative studies

Fluorine F 18 2-deoxy-2-(18F)fluoro-D-glucoseBIOLOGICAL

Undergo 18F-FDG PET scan

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Diagnosis of HCC with one or more of the following: 1. Liver mass with non-rim arterial phase hyperenhancement (APHE) and one of the following: 1) 10-19 mm with ≥2 additional major features according to LI-RADS criteria ("washout", enhancing "capsule", and/or threshold growth), 2) 10-19 mm with "washout" and visibility at antecedent ultrasound (US) but with no "capsule" or threshold growth, 3) 10-19 mm with ≥50% size increase in ≤6 months but with no "washout" or "capsule" or 4) ≥20 mm with ≥1 additional major feature according to LI-RADS criteria ("washout", enhancing "capsule", or threshold growth). 2. Lesions that meet LI-RADS 4 criteria or 3. Lesions that meet LI-RADS 5 criteria or 4. Suggestive imaging findings plus AFP \> 200 mg/dL or 5. Tumor confirmed by arteriography or 6. Pathologic confirmation of tumor or 2. Diagnosis of a benign abdominal or pelvic tumor with the following characteristics: 1. Liver mass (≥ 1 cm) that has suggestive imaging findings of a benign liver mass (adenoma, hemangioma, focal nodular hyperplasia). 2. Prior SOC MRI or CT of the benign lesion within 8 weeks of enrollment or 3. Diagnosis of a malignant non-HCC liver tumor with one or more of the following characteristics: 1. Liver mass (≥ 1 cm) that is biopsy proven, MRI-confirmed, or CT-confirmed metastatic disease (metastatic colorectal cancer, metastatic pancreatic cancer). 2. Liver mass (≥ 1 cm) that is a non-HCC primary malignancy (cholangiocarcinoma). 3. Prior SOC MRI or CT of the malignant non-HCC liver tumor within 8 weeks of enrollment or 4. Diagnosis of oligometastatic solid tumors in the following disease sites: colorectal, sarcoma, lung, head and neck, ovarian, renal, melanoma, pancreatic, prostate, cervix, breast, uterine and cholangiocarcinoma undergoing local consolidative therapy. and 5. Each patient must have completed conventional imaging and staging and MRI or CT before initiation of the investigational PET studies. and 6. Participants with HCC must be a candidate for liver resection, orthotopic liver transplant (OLT), or Y90 radioembolization. Exclusion Criteria: 1. Participants under the age of 18 will be excluded from this study. 2. Participants who have HCC or cholangiocarcinoma but are not candidates for liver resection surgery or OLT, or Y90 radioembolization. 3. Pregnant and breastfeeding patients. Adequate birth control measures (oral, implanted, or barrier methods) must be used by all female participants of childbearing potential until all research PET scans are completed. Female participants of childbearing potential must have a negative serum or urine pregnancy test within 24 hours of the proposed investigational PET/CT scan(s) prior to injection of the investigational radiopharmaceutical. 4. Participants with poorly controlled diabetes mellitus (fasting blood glucose level \> 200 mg/dL). 5. Participants with a known Infiltrative variant of HCC.

Outcomes

Primary Outcomes

18F-FSPG PET standardized uptake value (SUV)

The Standardized Uptake Value (SUV) for 18F-FSPG PET images will be determined in the hepatocellular carcinoma (HCC) tumor lesions, non-HCC liver tumors (benign), and background liver (normal tissue). These metrics include SUVmax, SUVpeak, or SUVmean and are common PET imaging measures.