Trials / Recruiting
RecruitingNCT02379377
18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant
PET Imaging of Hepatocellular Carcinoma With 18F-FSPG
- Status
- Recruiting
- Phase
- Phase 1
- Study type
- Interventional
- Enrollment
- 110 (estimated)
- Sponsor
- M.D. Anderson Cancer Center · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
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.
Conditions
- Adult Hepatocellular Carcinoma
- Resectable Hepatocellular Carcinoma
- Cholangiocarcinoma
- Benign Liver Tumor
- Metastases to Liver
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | Fluorine F 18 L-glutamate Derivative 18F-FSPG | Undergo 18F-FSPG PET scan |
| BIOLOGICAL | Carbon C 11 Acetate | Undergo 11C-acetate PET scan |
| PROCEDURE | Positron Emission Tomography | Undergo 18F-FSPG, 11C-acetate, or 18F-FDG PET |
| OTHER | Laboratory Biomarker Analysis | Correlative studies |
| BIOLOGICAL | Fluorine F 18 2-deoxy-2-(18F)fluoro-D-glucose | Undergo 18F-FDG PET scan |
Timeline
- Start date
- 2022-02-15
- Primary completion
- 2027-05-31
- Completion
- 2027-05-31
- First posted
- 2015-03-04
- Last updated
- 2026-03-09
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT02379377. Inclusion in this directory is not an endorsement.