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| ID | Type | Description | Link |
|---|---|---|---|
| NCI-2021-12377 | Registry Identifier | CTRP (Clinical Trial Reporting Program) |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Treatment (68GA PSMA PET/CT) | Experimental | 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. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Computed Tomography | Procedure | Undergo 68Ga PSMA PET/CT |
|
| Measure | Description | Time Frame |
|---|---|---|
| Time to treatment response | Defined as the time from study registration to complete response/partial response per Response Evaluation Criteria in Solid Tumors (RECIST) 1.1 and per PSMA positron emission tomography (PET)/computed tomography (CT). | Up to 12 cycles of treatment or 36 weeks |
| Progression free survival (PFS) at 6 months | Defined as the length of time during and after treatment that a patient lives with cancer without the disease worsening, per RECIST and PSMA PET/CT | At 6 months |
| Time to progression | Defined as the time from study registration to disease progression per RECIST 1.1 and PSMA PET/CT. | Up to 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nguyen H. Tran, MD | Mayo Clinic in Rochester | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Mayo Clinic in Rochester | Rochester | Minnesota | 55905 | United States |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Jan 27, 2026 |
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| Gallium Ga 68 Gozetotide | Drug | Undergo 68Ga PSMA PET/CT |
|
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| Positron Emission Tomography | Procedure | Undergo 68Ga PSMA PET/CT |
|
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| Feb 3, 2026 |
| Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 27, 2024 | Feb 3, 2026 | ICF_001.pdf |
| ID | Term |
|---|---|
| D006528 | Carcinoma, Hepatocellular |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008113 | Liver Neoplasms |
| D004067 | Digestive System Neoplasms |
| D009371 | Neoplasms by Site |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |
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| ID | Term |
|---|---|
| C000718244 | gallium 68 PSMA-11 |
| C000622699 | 68Ga-DKFZ-PSMA-11 |
| D009682 | Magnetic Resonance Spectroscopy |
| ID | Term |
|---|---|
| D013057 | Spectrum Analysis |
| D002623 | Chemistry Techniques, Analytical |
| D008919 | Investigative Techniques |
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