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

M.D. Anderson Cancer Center

Status and phase: Enrolling; Phase 1

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

Treatments: Other: Laboratory Biomarker Analysis; Biological: Fluorine F 18 2-deoxy-2-(18F)fluoro-D-glucose; Biological: Carbon C 11 Acetate; Procedure: Positron Emission Tomography; Biological: Fluorine F 18 L-glutamate Derivative 18F-FSPG

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02379377

U24CA220325 (U.S. NIH Grant/Contract)

2020-1084

NCI-2015-00184 (Registry Identifier)

Details and patient eligibility

About

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.

Full 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 for liver resection surgery and orthotopic liver transplant (OLT).

II. To compare 18F-FSPG PET/CT with standard-of-care (SOC) diagnostic MRI imaging in patients with suspected HCC scheduled for liver resection surgery or OLT.

III. To compare the uptake of 18F-FSPG PET/CT with 11C-acetate PET/CT AND 18F-FDG PET/CT in suspected HCC and background liver in patients scheduled for liver resection surgery or OLT.

IV. To evaluate uptake of 18F-FSPG PET/CT in benign liver lesions compared to background.

V. To evaluate uptake of 18F-FSPG PET/CT in malignant non-HCC liver tumors.

OUTLINE:

Patients undergo 18F-FSPG PET and either carbon-11 (11C)-acetate PET or 18F-FDG PET scans within 4 weeks of surgery or OLT.

Enrollment: 110 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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110 participants in 2 patient groups

Diagnostic (18F-FSPG PET)

Experimental group

Description:

Patients undergo an 18F-FSPG PET scan within 4 weeks of surgery or OLT. Patients may also receive a second 18F-FSPG PET scan following standard-of-care treatment.

Treatment:

Procedure: Positron Emission Tomography

Biological: Fluorine F 18 L-glutamate Derivative 18F-FSPG

Other: Laboratory Biomarker Analysis

Diagnostic (11C-Acetate PET or 18F-FDG PET)

Experimental group

Description:

Patients may undergo either carbon-11 (11C)-Acetate PET or 18F-FDG PET scans within 4 weeks of surgery or OLT.

Treatment:

Procedure: Positron Emission Tomography

Biological: Fluorine F 18 L-glutamate Derivative 18F-FSPG

Biological: Carbon C 11 Acetate

Biological: Fluorine F 18 2-deoxy-2-(18F)fluoro-D-glucose

Other: Laboratory Biomarker Analysis