NCT07116486

A Trial Utilizing 18F-FS PG PET to Guide Therapy in Hepatocellular Carcinoma

Phase 1, Single-site, Single-arm, Clinical Imaging, and Blood-based Biomarker Trial Utilizing 18F-FSPG PET to Guide Therapy in Hepatocellular Carcinoma

• Status: Recruiting
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 60 (estimated)
• Sponsor: M.D. Anderson Cancer Center · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

To evaluate the relationship between 18F-FSPG uptake in HCC lesions, ctDNA in blood and clinical response to Y90 radioembolization therapy in patients with hepatocellular carcinoma (HCC) by SOC imaging.

Detailed description

Primary Objectives: 1. To establish whether pre-treatment 18F-FSPG can be utilized as an imaging marker to predict response/resistance to Y90 treatment, 2. To determine whether there is a correlation between change in 18F-FSPG uptake in HCC lesions and change in levels of ctDNA in the blood prior to and post-Y90 radioembolization and response to treatment as assessed by SOC imaging at 3-, 6-, 9-, and 12-months following the procedure. Secondary Objectives: 1. To determine if 18F-FSPG PET can visualize residual disease, 2. To determine if ctDNA can detect residual disease, 3. To determine the concordance of tumor detection by 18F-FSPG PET/CT imaging and SOC imaging. 4. To establish whether 18F-FSPG uptake and levels of ctDNA can be utilized as imaging and bloodbased markers, respectively, to inform the response to therapy or lack thereof earlier than SOC imaging. 5. To evaluate the relationship between 18F-FSPG PET, ctDNA, and SOC imaging to TTP or PFS. 6. To evaluate voxel-wise relationships between 18F-FSPG intra-tumoral accumulation and SOC imaging. 7. To evaluate the treatment response using the mRECIST and LI-RADS criteria.

Conditions

• Hepatocellular Carcinoma

Interventions

Type	Name	Description
DIAGNOSTIC_TEST	Radiopharmaceutical 18F-FSPG	Given by injection

Timeline

• Start date: 2025-12-02
• Primary completion: 2030-06-30
• Completion: 2032-06-30
• First posted: 2025-08-11
• Last updated: 2026-02-19

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study