Clinical trial NCT02379377: 18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant
Official title: PET Imaging of Hepatocellular Carcinoma With 18F-FSPG
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE1
Conditions: Adult Hepatocellular Carcinoma
Resectable Hepatocellular Carcinoma
Cholangiocarcinoma
Benign Liver Tumor
Metastases to Liver
Lead sponsor: M.D. Anderson Cancer Center
Sponsor class: OTHER
Collaborators: name: National Cancer Institute (NCI)
First posted: 2015-03-04
Enrollment: 110
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Cohorts A and B are Parallel. Cohorts C and D are Single Group. Cohorts E and F Single Group
Primary purpose: DIAGNOSTIC

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. Diagnostic procedures, such as 18F-FSPG PET, may help find and diagnose liver cancer and find out how far the disease has spread.

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 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.

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.

Primary outcomes:
measure: 18F-FSPG PET standardized uptake value (SUV)
timeFrame: Within 4 weeks of standard-of-care imaging, within 4 weeks of liver resection surgery, within 12 months of orthotopic liver transplant and prior to therapy
measure: 11C-acetate standardized uptake value (SUV)
timeFrame: Within 4 weeks of standard-of-care imaging, within 4 weeks of liver resection surgery, within 12 months of orthotopic liver transplant and prior to therapy
measure: 18F-FDG standardized uptake value (SUV)
timeFrame: Within 4 weeks of standard-of-care imaging, within 4 weeks of liver resection surgery, within 12 months of orthotopic liver transplant and prior to therapy
measure: Pharmacokinetics of 18F-FSPG, 11C-acetate, and 18F-FDG
timeFrame: Within 4 weeks of standard-of-care imaging, within 4 weeks of liver resection surgery, within 12 months of orthotopic liver transplant and prior to therapy
measure: Number of lesions
timeFrame: Within 4 weeks of liver resection surgery, within 12 months of orthotopic liver transplant and prior to therapy
measure: Sensitivity of 18F-FSPG PET imaging
timeFrame: Within 4 weeks of standard-of-care imaging, within 4 weeks of liver resection surgery, within 12 months of orthotopic liver transplant and prior to therapy
measure: Specificity of 18F-FSPG PET imaging
timeFrame: Within 4 weeks of standard-of-care imaging, within 4 weeks of liver resection surgery, within 12 months of orthotopic liver transplant and prior to therapy
measure: Diagnostic pathology
timeFrame: After surgery; Through study completion, up to 4 years
measure: Tumor grade
timeFrame: After surgery; Through study completion, up to 4 years
measure: Immunohistochemistry
timeFrame: After surgery; Through study completion, up to 4 years
Secondary outcomes:
measure: Metabolic profile
timeFrame: After surgery; Through study completion, up to 4 years
measure: Milan classification
timeFrame: Baseline prior to imaging and surgery
Other outcomes:
Locations:
city: Houston
country: United States
facility: MD Anderson Cancer Center
state: Texas
Study officials:
affiliation: M.D. Anderson Cancer Center
name: Simone S Krebs, MD
role: PRINCIPAL_INVESTIGATOR
References: