Brief Title
18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant
Official Title
PET Imaging of Hepatocellular Carcinoma With 18F-FSPG
Brief Summary
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.
Detailed Description
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 Phase
Phase 1
Study Type
Interventional
Primary Outcome
18F-FSPG PET standardized uptake value (SUV)
Secondary Outcome
Metabolic profile
Condition
Adult Hepatocellular Carcinoma
Intervention
Fluorine F 18 L-glutamate Derivative 18F-FSPG
Study Arms / Comparison Groups
Diagnostic (18F-FSPG PET)
Description: Patients undergo an 18F-FSPG PET scan within 4 weeks of surgery or OLT. Patients may also receive a second 18F-FSPG PET scan following standard-of-care treatment.
Publications
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.
Recruitment Information
Recruitment Status
Biological
Estimated Enrollment
80
Start Date
February 15, 2022
Completion Date
May 31, 2025
Primary Completion Date
May 31, 2024
Eligibility Criteria
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. Suggestive imaging findings plus AFP > 200 mg/dL; or 3. Tumor confirmed by arteriography. or 2. Diagnosis of a benign liver 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 of the benign liver lesion within 4 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 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 of the malignant non-HCC liver tumor within 4 weeks of enrollment and 3. Each patient must have completed conventional imaging and staging and MRI before initiation of the investigational PET studies. and 4. Patients with HCC or cholangiocarcinoma must be a candidate for liver resection or orthotopic liver transplant (OLT) Exclusion Criteria: 1. Patients under the age of 18 will be excluded from this study. 2. Patients who have HCC or cholangiocarcinoma but are not candidates for liver resection surgery or OLT 3. Patients with a known prior malignancy who have received systemic chemotherapy within five years. 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 not excluded. 4. Pregnant and breastfeeding patients. 5. Patients with poorly controlled diabetes mellitus (fasting blood glucose level > 200 mg/dL). 6. Patients with a known Infiltrative variant of HCC.
Gender
All
Ages
18 Years - N/A
Accepts Healthy Volunteers
No
Contacts
Lesley Flynt, MD, 713-745-8760, [email protected]
Location Countries
United States
Location Countries
United States
Administrative Informations
NCT ID
NCT02379377
Organization ID
2020-1084
Secondary IDs
NCI-2015-00184
Responsible Party
Sponsor
Study Sponsor
M.D. Anderson Cancer Center
Collaborators
National Cancer Institute (NCI)
Study Sponsor
Lesley Flynt, MD, Principal Investigator, M.D. Anderson Cancer Center
Verification Date
September 2022