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:

  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.

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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Page 1 of 1 (1 locations)

1

MD Anderson Cancer Center

Houston, Texas, United States, 77090

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