Advanced Hepatocellular CarcinomaPhase 2NCT05176223
68Ga PSMA PET Imaging for the Treatment of Advanced Liver Cancer
A Phase 2 study testing Computed Tomography, Gallium Ga 68 Gozetotide and Positron Emission Tomography in people with Advanced Hepatocellular Carcinoma and Stage III Hepatocellular Carcinoma AJCC v8, run by Mayo Clinic at 1 site in United States.
Trial 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). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8
- What is being tested?
- Computed Tomography, Gallium Ga 68 Gozetotide and Positron Emission Tomography
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 26 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jan 2022to 31 Dec 2025
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
United States1 site
Mayo Clinic in Rochester
Rochester, Minnesota, 55905
About this study
Official title: Optimizing Outcomes of Patients With Advanced HCC Undergoing Immunotherapy Through Novel 68Ga PSMA PET Imaging
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.
Read the detailed description
PRIMARY OBJECTIVES:
- 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
- Being tested
- Computed Tomography, Gallium Ga 68 Gozetotide, Positron Emission Tomography
- Medical subject headings
- Carcinoma, Hepatocellular
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Computed TomographyProcedure or surgery
Also called CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography
Undergo 68Ga PSMA PET/CT
Gallium Ga 68 GozetotideDrug
Also called (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
Undergo 68Ga PSMA PET/CT
Positron Emission TomographyProcedure or surgery
Also called Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan
Undergo 68Ga PSMA PET/CT
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Procedure: Computed Tomography; Drug: Gallium Ga 68 Gozetotide; Procedure: Positron Emission Tomography |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 36 weeks
Proportion of 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
Measured: 6 months
Time to Progression
Defined as the time from study registration to disease progression per RECIST 1.1 and PSMA PET/CT.
Measured: 32 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jan 2022
- Study start30 Jan 2022
- Primary completion31 Dec 2025
- Study completion31 Dec 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Advanced Hepatocellular CarcinomaStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 26 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Nguyen H. Tran, MD, Principal investigator, Mayo Clinic in Rochester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05176223
- Sponsor's protocol ID
- 21-007799
- Other IDs
- NCI-2021-12377
- Status last verified
- Sep 2026
- First submitted
- 22 Nov 2021
- Last updated
- 29 Sep 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Outcomes of Patients With Advanced HCC Undergoing Immunotherapy Through Novel 68Ga PSMA PET Imaging
- ClinicalTrials.gov ID
- NCT05176223
- Acronym / sponsor ID
- 21-007799
- Conditions
- Advanced Hepatocellular Carcinoma, Stage III Hepatocellular Carcinoma AJCC v8, Stage IV Hepatocellular Carcinoma AJCC v8, Unresectable Hepatocellular Carcinoma
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 26 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Study start
- 30 Jan 2022 (actual)
- Primary completion
- 31 Dec 2025 (actual)
- Study completion
- 31 Dec 2025 (actual)
- First posted
- 4 Jan 2022 (actual)
- Results
- Posted 29 Sep 2026
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- 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.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Treatment (68GA PSMA PET/CT) | Experimental | Procedure: Computed Tomography, Drug: Gallium Ga 68 Gozetotide, Procedure: Positron Emission TomographyPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (2 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Computed TomographyAlso: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial TomographyUndergo 68Ga PSMA PET/CT | Procedure or surgery | Treatment (68GA PSMA PET/CT) |
| Gallium Ga 68 GozetotideAlso: (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-CCUndergo 68Ga PSMA PET/CT | Drug | Treatment (68GA PSMA PET/CT) |
| Positron Emission TomographyAlso: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography ScanUndergo 68Ga PSMA PET/CT | Procedure or surgery | Treatment (68GA PSMA PET/CT) |
Primary outcome
Time to Treatment Response
Time frame: 36 weeks
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).
Proportion of Progression Free Survival (PFS) at 6 Months
Time frame: 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
Time to Progression
Time frame: 32 months
Defined as the time from study registration to disease progression per RECIST 1.1 and PSMA PET/CT.
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Nguyen H. Tran, MD principal investigator
Mayo Clinic in Rochester
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Computed Tomography, Gallium Ga 68 Gozetotide and Positron Emission Tomography in people with Advanced Hepatocellular Carcinoma and Stage III Hepatocellular Carcinoma AJCC v8, run by Mayo Clinic at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 29 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 29 Sep 2026). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to Treatment Response (time frame: 36 weeks). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Sep 2026.