Status:
RECRUITING
18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant
Lead Sponsor:
M.D. Anderson Cancer Center
Collaborating Sponsors:
National Cancer Institute (NCI)
Conditions:
Adult Hepatocellular Carcinoma
Resectable Hepatocellular Carcinoma
Eligibility:
All Genders
18+ years
Phase:
PHASE1
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....
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...
Eligibility Criteria
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: 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 Criteria:
- 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.
Key Trial Info
Start Date :
February 15 2022
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
May 31 2027
Estimated Enrollment :
110 Patients enrolled
Trial Details
Trial ID
NCT02379377
Start Date
February 15 2022
End Date
May 31 2027
Last Update
March 9 2026
Active Locations (1)
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1
MD Anderson Cancer Center
Houston, Texas, United States, 77090