68Ga PSMA PET Imaging for the Treatment of Advanced Liver Cancer

NCT ID: NCT05176223

Last Updated: 2025-08-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Clinical Phase

PHASE2

Total Enrollment

30 participants

Study Classification

INTERVENTIONAL

Study Start Date

2022-01-30

Study Completion Date

2027-11-30

Brief Summary

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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.

Detailed Description

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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

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Advanced Hepatocellular Carcinoma Stage III Hepatocellular Carcinoma AJCC v8 Stage IV Hepatocellular Carcinoma AJCC v8 Unresectable Hepatocellular Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Treatment (68GA PSMA PET/CT)

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.

Group Type EXPERIMENTAL

Computed Tomography

Intervention Type PROCEDURE

Undergo 68Ga PSMA PET/CT

Gallium Ga 68 Gozetotide

Intervention Type DRUG

Undergo 68Ga PSMA PET/CT

Positron Emission Tomography

Intervention Type PROCEDURE

Undergo 68Ga PSMA PET/CT

Interventions

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Computed Tomography

Undergo 68Ga PSMA PET/CT

Intervention Type PROCEDURE

Gallium Ga 68 Gozetotide

Undergo 68Ga PSMA PET/CT

Intervention Type DRUG

Positron Emission Tomography

Undergo 68Ga PSMA PET/CT

Intervention Type PROCEDURE

Other Intervention Names

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CAT CAT Scan Computed Axial Tomography Computerized Axial Tomography Computerized Tomography CT CT Scan tomography (68)Ga labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC (68)Ga-labeled Glu-urea-Lys(Ahx)-HBED-CC (68)Ga-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC (68)Gallium-PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC (68Ga)Glu-urea-Lys(Ahx)-HBED-CC 68Ga-DKFZ-PSMA-11 68Ga-HBED-CC-PSMA 68Ga-labeled Glu-NH-CO-NH-Lys(Ahx)-HBED-CC 68Ga-PSMA 68Ga-PSMA-11 68Ga-PSMA-HBED-CC [68Ga] Prostate-specific Membrane Antigen 11 [68Ga]GaPSMA-11 Ga PSMA Ga-68 labeled DKFZ-PSMA-11 Ga-68 labeled PSMA-11 GA-68 PSMA-11 Gallium Ga 68 PSMA-11 Gallium Ga 68-labeled PSMA-11 GALLIUM GA-68 GOZETOTIDE Gallium-68 PSMA Gallium-68 PSMA Ligand Glu-urea-Lys(Ahx)-HBED-CC GaPSMA PSMA-HBED-CC GA-68 Medical Imaging, Positron Emission Tomography PET PET Scan Positron Emission Tomography Scan Positron-Emission Tomography proton magnetic resonance spectroscopic imaging PT

Eligibility Criteria

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Inclusion Criteria

* Patient with pathologically confirmed HCC not amenable to curative resection, transplantation or ablative therapies
* Have radiographically measurable disease by RECIST
* Eligible for atezolizumab/bevacizumab front line therapy
* Male or female with age greater than 18 years, with the capacity and willingness to provide written informed consent

Exclusion Criteria

* Pregnant and/or breast-feeding patients. A negative pregnancy test within 48 hours of the PET scan
* Patients with higher than the weight/size limitations of PET/CT scanner
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Mayo Clinic

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Nguyen H. Tran, MD

Role: PRINCIPAL_INVESTIGATOR

Mayo Clinic in Rochester

Locations

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Mayo Clinic in Rochester

Rochester, Minnesota, United States

Site Status

Countries

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United States

Other Identifiers

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NCI-2021-12377

Identifier Type: REGISTRY

Identifier Source: secondary_id

21-007799

Identifier Type: -

Identifier Source: org_study_id

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