18F-FSPG PET in Imaging Patients with Liver Cancer before Undergoing Surgery, Transplant or Y90 Radioembolization
This phase I 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, transplant or Y90 radioembolization. Diagnostic procedures, such as 18F-FSPG PET, may help find and diagnose liver cancer and find out how far the disease has spread.
Inclusion Criteria
- Diagnosis of HCC with one or more of the following: * Liver mass with non-rim arterial phase hyperenhancement (APHE) and one of the following: ** 10-19 mm with >= 2 additional major features according to Liver Imaging Reporting and Data System (LI-RADS) criteria (“washout”, enhancing “capsule”, and/or threshold growth) ** 10-19 mm with “washout” and visibility at antecedent ultrasound (US) but with no “capsule” or threshold growth ** 10-19 mm with >= 50% size increase in =< 6 months but with no “washout” or “capsule” or ** >= 20 mm with >= 1 additional major feature according to LI-RADS criteria (“washout”, enhancing “capsule”, or threshold growth) * Lesions that meet Liver Imaging Reporting and Data System (LI-RADS) 4 criteria or * Lesions that meet LI-RADS 5 criteria or * Suggestive imaging findings plus AFP > 200 mg/dL; or * Tumor confirmed by arteriography * Pathologic confirmation of tumor or
 - Diagnosis of a benign abdominal or pelvic tumor with the following characteristics: * Liver mass (>= 1 cm) that has suggestive imaging findings of a benign liver mass (adenoma, hemangioma, focal nodular hyperplasia) * Prior standard of care (SOC) MRI or CT of the benign lesion within 8 weeks of enrollment or
 - Diagnosis of a malignant non-HCC liver tumor with one or more of the following characteristics: * Liver mass (>= 1 cm) that is biopsy proven, MRI-confirmed, or CT-confirmed metastatic disease (metastatic colorectal cancer, metastatic pancreatic cancer) * Liver mass (>= 1 cm) that is a non-HCC primary malignancy (cholangiocarcinoma) * Prior SOC MRI or CT of the malignant non-HCC liver tumor within 8 weeks of enrollment and
 - Each patient must have completed conventional imaging and staging and MRI or CT before initiation of the investigational PET studies and
 - Patients with HCC must be a candidate for liver resection, orthotopic liver transplant (OLT), or Y90 radioembolization
 
Exclusion Criteria
- Patients under the age of 18 will be excluded from this study
 - Patients who have HCC but are not candidates for liver resection surgery or OL, or Y90 radioembolization
 - Pregnant and breastfeeding patients
 - 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 subjects 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
 - Patients with poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL)
 - Patients with a known infiltrative variant of HCC
 
Additional locations may be listed on ClinicalTrials.gov for NCT02379377.
Locations matching your search criteria
United States
Tennessee
Nashville
Texas
Houston
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 magnetic resonance imaging (MRI) imaging or computed tomography (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 and fludeoxyglucose F-18 (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.
VI. To evaluate the relationship between 18F-FSPG uptake and clinical response in patients with hepatocellular carcinoma (HCC) scheduled for Y90 radioembolization.
OUTLINE: Patients are assigned to 1 of 4 cohorts based on disease type.
COHORTS A AND B: Patients with HCC undergoing surgery (Cohort A) or undergoing orthotopic liver transplant (Cohort B) are randomized to 1 of 2 arms.
ARM I: Patients undergo 11C-acetate PET/CT scan over approximately 40 minutes. Patients then receive 18F-FSPG intravenously (IV) and undergo a PET/CT scan over approximately 40 minutes. Both scans will be conducted on the same day, if feasible, but should not exceed 7 days between each scan.
ARM II: Patients receive 18-F FDG and undergo a PET/CT scan over approximately 40 minutes. The next day, patients receive 18F-FSPG IV, then undergo a PET/CT scan over approximately 40 minutes.
COHORT C AND D: Patients with a prior diagnosis of at least one benign lesion of the liver (Cohort C) or with a diagnosis of malignant non-HCC liver tumors (Cohort D) receive 18F-FSPG IV and undergo a PET/CT scan over approximately 40 minutes.
COHORT E: Patients with HCC receive Y90 radioembolization and receive 18F-FSPG IV and undergo a PET/CT scan over approximately 40 minutes.
Trial PhasePhase I
Trial Typediagnostic
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorSimone Krebs
- Primary ID2020-1084
 - Secondary IDsNCI-2015-00184, VICC GI 14124
 - ClinicalTrials.gov IDNCT02379377