PET Imaging of Hepatocellular Carcinoma With 18F-FSPG
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.
• Diagnosis of HCC with one or more of the following:
‣ 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).
⁃ Lesions that meet LI-RADS 4 criteria or
⁃ Suggestive imaging findings plus AFP \> 200 mg/dL or
⁃ Tumor confirmed by arteriography or
⁃ 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 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 or
• 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.
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• Each patient must have completed conventional imaging and staging and MRI or CT before initiation of the investigational PET studies.
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• Participants with HCC must be a candidate for liver resection, orthotopic liver transplant (OLT), or Y90 radioembolization.