18F-FSPG PET in Imaging Patients With Liver Cancer Before Undergoing Surgery or Transplant
NCT ID: NCT02379377
Last Updated: 2025-09-26
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE1
110 participants
INTERVENTIONAL
2022-02-15
2027-05-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
PET Imaging of Ovarian Carcinoma With 18F-FSPG
NCT02872519
Positron Emission Tomography Using Carbon-11 Acetate and Fludeoxyglucose F 18 in Detecting Hepatocellular Carcinoma (Liver Cancer) in Patients With Known or Suspected Liver Cancer
NCT00081094
FDGal PET/CT to Detect Hepatocellular Carcinoma
NCT02899325
A Trial Utilizing 18F-FS PG PET to Guide Therapy in Hepatocellular Carcinoma
NCT07116486
Fludeoxyglucose F 18-PET Imaging for Early Detection of Residual Disease in Patients Undergoing Radiofrequency Ablation of Liver Metastases From Colorectal Cancer
NCT00499395
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Diagnostic (18F-FSPG PET)
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.
Fluorine F 18 L-glutamate Derivative 18F-FSPG
Undergo 18F-FSPG PET scan
Positron Emission Tomography
Undergo 18F-FSPG, 11C-acetate, or 18F-FDG PET
Laboratory Biomarker Analysis
Correlative studies
Diagnostic (11C-Acetate PET or 18F-FDG PET)
Patients may undergo either carbon-11 (11C)-Acetate PET or 18F-FDG PET scans within 4 weeks of surgery or OLT.
Fluorine F 18 L-glutamate Derivative 18F-FSPG
Undergo 18F-FSPG PET scan
Carbon C 11 Acetate
Undergo 11C-acetate PET scan
Positron Emission Tomography
Undergo 18F-FSPG, 11C-acetate, or 18F-FDG PET
Laboratory Biomarker Analysis
Correlative studies
Fluorine F 18 2-deoxy-2-(18F)fluoro-D-glucose
Undergo 18F-FDG PET scan
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Fluorine F 18 L-glutamate Derivative 18F-FSPG
Undergo 18F-FSPG PET scan
Carbon C 11 Acetate
Undergo 11C-acetate PET scan
Positron Emission Tomography
Undergo 18F-FSPG, 11C-acetate, or 18F-FDG PET
Laboratory Biomarker Analysis
Correlative studies
Fluorine F 18 2-deoxy-2-(18F)fluoro-D-glucose
Undergo 18F-FDG PET scan
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
National Cancer Institute (NCI)
NIH
M.D. Anderson Cancer Center
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Simone S Krebs, MD
Role: PRINCIPAL_INVESTIGATOR
M.D. Anderson Cancer Center
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
MD Anderson Cancer Center
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Related Links
Access external resources that provide additional context or updates about the study.
MD Anderson Cancer Center
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
NCI-2015-00184
Identifier Type: REGISTRY
Identifier Source: secondary_id
2020-1084
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.