RecruitingPhase 1NCT02379377

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

PET Imaging of Hepatocellular Carcinoma With 18F-FSPG

Sponsor

M.D. Anderson Cancer Center

Enrollment

110 participants

Start Date

Feb 15, 2022

Study Type

INTERVENTIONAL

Conditions

Cholangiocarcinoma Benign Liver Tumor Adult Hepatocellular Carcinoma Resectable Hepatocellular Carcinoma Metastases to Liver

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.

Eligibility

Min Age: 18 Years

Inclusion Criteria19

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
Lesions that meet LI-RADS 5 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.
and
Each patient must have completed conventional imaging and staging and MRI or CT before initiation of the investigational PET studies.
and
Participants with HCC must be a candidate for liver resection, orthotopic liver transplant (OLT), or Y90 radioembolization.

Exclusion Criteria5

Participants under the age of 18 will be excluded from this study.
Participants who have HCC or cholangiocarcinoma but are not candidates for liver resection surgery or OLT, or Y90 radioembolization.
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.
Participants with poorly controlled diabetes mellitus (fasting blood glucose level \> 200 mg/dL).
Participants with a known Infiltrative variant of HCC.