68Ga PSMA PET Imaging for the Treatment of Advanced Liver Cancer
NCT ID: NCT05176223
Last Updated: 2025-08-29
Study Results
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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ACTIVE_NOT_RECRUITING
PHASE2
30 participants
INTERVENTIONAL
2022-01-30
2027-11-30
Brief Summary
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Detailed Description
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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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Study Design
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NA
SINGLE_GROUP
TREATMENT
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.
Computed Tomography
Undergo 68Ga PSMA PET/CT
Gallium Ga 68 Gozetotide
Undergo 68Ga PSMA PET/CT
Positron Emission Tomography
Undergo 68Ga PSMA PET/CT
Interventions
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Computed Tomography
Undergo 68Ga PSMA PET/CT
Gallium Ga 68 Gozetotide
Undergo 68Ga PSMA PET/CT
Positron Emission Tomography
Undergo 68Ga PSMA PET/CT
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* Patients with higher than the weight/size limitations of PET/CT scanner
18 Years
ALL
No
Sponsors
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Mayo Clinic
OTHER
Responsible Party
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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
Countries
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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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