This phase I trial studies whether 18F-FSPG positron emission tomography (PET) can be used to predict response or resistance to yttrium-90 (Y90) treatment in hepatocellular carcinoma (HCC) patients. PET is an established imaging technique that utilizes small amounts of radioactivity attached to very minimal amounts of tracer, in the case of this research, 18F-FSPG. 18F-FSPG is specifically taken up by the tumor cells via the system xC-transporter (xCT). Upon uptake, xCT activity can be assessed and tumor cells can be detected and imaged by PET. Since elevated xCT activity is a sign of resistance to radiation therapy and 18F-FSPG PET identifies xCT activity, 18F-FSPG PET may be an effective way to predict response or resistance to Y90 treatment in HCC patients.
Additional locations may be listed on ClinicalTrials.gov for NCT07116486.
Locations matching your search criteria
United States
Texas
Houston
M D Anderson Cancer CenterStatus: Approved
Contact: Simone Krebs
Phone: 713-563-6726
PRIMARY OBJECTIVES:
I. To establish whether pre-treatment fluorine F 18 florilglutamic acid (18F-FSPG) can be utilized as an imaging marker to predict response/resistance to Y90 treatment.
II. To determine whether there is a correlation between change in 18F-FSPG uptake in HCC lesions and change in levels of circulating tumor deoxyribonucleic acid (ctDNA) in the blood prior to and post-Y90 radioembolization and response to treatment as assessed by standard of care (SOC) imaging at 3-, 6-, 9-, and 12-months following the procedure.
SECONDARY OBJECTIVES:
I. To determine if 18F-FSPG PET can visualize residual disease.
II. To determine if ctDNA can detect residual disease.
III. To determine the concordance of tumor detection by 18F-FSPG PET/computed tomography (CT) imaging and SOC imaging.
IV. To establish whether 18F-FSPG uptake and levels of ctDNA can be utilized as imaging and blood-based markers, respectively, to inform the response to therapy or lack thereof earlier than SOC imaging.
V. To evaluate the relationship between 18F-FSPG PET, ctDNA, and SOC imaging to time to progression (TTP) or progression-free survival (PFS).
VI. To evaluate voxel-wise relationships between 18F-FSPG intra-tumoral accumulation and SOC imaging.
VII. To evaluate the treatment response using the Modified Response Evaluation Criteria in Solid Tumors (mRECIST) and Liver Imaging and Reporting Data System (LI-RADS) criteria.
EXPLORATORY OBJECTIVES:
I. To evaluate the ability of 18F-FSPG PET imaging to predict response to Y90 therapy.
II. Compare the voxel-wise distribution of 18F-FSPG and Y90 microspheres.
OUTLINE:
Patients receive 18F-FSPG intravenously (IV) over 2-5 minutes and undergo dynamic PET over 58 minutes followed by a whole-body PET over 18 minutes at baseline (within 4 weeks of SOC imaging but no more than 2 weeks prior to Y90 treatment) and at 3- and 6-months post-Y90 treatment in the absence of unacceptable toxicity. Patients also undergo CT throughout the study and blood sample collection on study.
After completion of study intervention, patients are followed up at 30 days.
Lead OrganizationM D Anderson Cancer Center
Principal InvestigatorSimone Krebs