Trials / Completed
CompletedNCT05176223
68Ga PSMA PET Imaging for the Treatment of Advanced Liver Cancer
Optimizing Outcomes of Patients With Advanced HCC Undergoing Immunotherapy Through Novel 68Ga PSMA PET Imaging
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 29 (actual)
- Sponsor
- Mayo Clinic · Academic / Other
- Sex
- All
- Age
- 18 Years
- Healthy volunteers
- Not accepted
Summary
This phase II trial tests whether 68-Gallium prostate specific membrane antigen (68Ga-PSMA) positron emission tomography (PET) imaging can improve the diagnosis and management of liver cancer that has spread to other parts of the body (advanced). PSMA is a protein that appears in large amounts on the surface of liver cancer cells. The radioactive chemical compound (68Ga-PSMA) has been designed to circulate through the body and attach itself to the PSMA protein on liver cancer cells. A PET scan is then used to detect the location of the tumor cells. 68Ga-PSMA PET may improve upon the diagnosis and management of liver cancer.
Detailed description
PRIMARY OBJECTIVES: I. To test the performance of novel biomarkers derived from PSMA PET/computed tomography (CT) to measure response compared to Response Evaluation Criteria in Solid Tumors (RECIST) criteria, in advanced hepatocellular carcinoma (HCC) patients treated with immunotherapy. II. To identify precision imaging biomarkers that can predict response of HCC to novel immunotherapy. OUTLINE: Patients undergo 68GA PSMA PET/CT scans at baseline, and after 3, 6, 9, and 12 cycles of standard of care immunotherapy in the absence of disease progression or unacceptable toxicity. After completion of study treatment, patients are followed-up every 6 months for 3 years.
Conditions
- Advanced Hepatocellular Carcinoma
- Stage III Hepatocellular Carcinoma AJCC v8
- Stage IV Hepatocellular Carcinoma AJCC v8
- Unresectable Hepatocellular Carcinoma
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Computed Tomography | Undergo 68Ga PSMA PET/CT |
| DRUG | Gallium Ga 68 Gozetotide | Undergo 68Ga PSMA PET/CT |
| PROCEDURE | Positron Emission Tomography | Undergo 68Ga PSMA PET/CT |
Timeline
- Start date
- 2022-01-30
- Primary completion
- 2025-12-31
- Completion
- 2025-12-31
- First posted
- 2022-01-04
- Last updated
- 2026-02-05
Locations
1 site across 1 country: United States
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT05176223. Inclusion in this directory is not an endorsement.