Imaging liver cancer using a specialized PET scan before surgery or transplant

PET Imaging of Hepatocellular Carcinoma With 18F-FSPG

This study is testing a special PET scan to see if it can better diagnose liver cancer in patients who are about to have surgery or a transplant.

Quick facts

• Phase: PHASE1
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years and up
• Sex: All
• Sponsor: M.D. Anderson Cancer Center (other)
• Locations: 1 site (Houston, Texas)
• Trial ID: NCT02379377 on ClinicalTrials.gov

What this trial studies

This clinical trial evaluates the effectiveness of 18F-FSPG PET imaging in diagnosing liver cancer in patients scheduled for surgery or liver transplant. The study aims to compare 18F-FSPG PET/CT with standard MRI imaging and other PET imaging techniques to assess cancer metabolism and disease spread. Patients will undergo PET scans within four weeks prior to their surgical procedures, allowing for a comprehensive analysis of their liver tumors. The trial focuses on various liver conditions, including hepatocellular carcinoma and benign liver tumors.

Who should consider this trial

Good fit: Ideal candidates include adults diagnosed with hepatocellular carcinoma or other liver tumors who are scheduled for surgery or transplant.

Not a fit: Patients with liver cancer who are not candidates for surgery or transplant may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could improve the accuracy of liver cancer diagnosis and treatment planning, leading to better patient outcomes.

How similar studies have performed: Other studies have shown promise in using advanced PET imaging techniques for cancer diagnosis, suggesting potential success for this approach.

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. Lesions that meet LI-RADS 4 criteria or
   3. Lesions that meet LI-RADS 5 criteria or
   4. Suggestive imaging findings plus AFP \> 200 mg/dL or
   5. Tumor confirmed by arteriography or
   6. Pathologic confirmation of tumor or
2. Diagnosis of a benign abdominal or pelvic 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 or CT of the benign lesion within 8 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, MRI-confirmed, or CT-confirmed 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 or CT of the malignant non-HCC liver tumor within 8 weeks of enrollment or
4. 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
5. Each patient must have completed conventional imaging and staging and MRI or CT before initiation of the investigational PET studies.

   and
6. Participants with HCC must be a candidate for liver resection, orthotopic liver transplant (OLT), or Y90 radioembolization.

Exclusion Criteria:

1. Participants under the age of 18 will be excluded from this study.
2. Participants who have HCC or cholangiocarcinoma but are not candidates for liver resection surgery or OLT, or Y90 radioembolization.
3. 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.
4. Participants with poorly controlled diabetes mellitus (fasting blood glucose level \> 200 mg/dL).
5. Participants with a known Infiltrative variant of HCC.

Where this trial is running

Houston, Texas

• MD Anderson Cancer Center — Houston, Texas, United States (RECRUITING)

Study contacts

• Principal investigator: Simone S Krebs, MD — M.D. Anderson Cancer Center
• Study coordinator: Simone S Krebs, MD

Conditions: Adult Hepatocellular Carcinoma, Resectable Hepatocellular Carcinoma, Cholangiocarcinoma, Benign Liver Tumor, Metastases to Liver