NCT05176223

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
29

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jan 2022

Typical duration for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 22, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

January 4, 2022

Completed
26 days until next milestone

Study Start

First participant enrolled

January 30, 2022

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2025

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2025

Completed
Last Updated

February 5, 2026

Status Verified

February 1, 2026

Enrollment Period

3.9 years

First QC Date

November 22, 2021

Last Update Submit

February 3, 2026

Conditions

Advanced Hepatocellular CarcinomaStage III Hepatocellular Carcinoma AJCC v8Stage IV Hepatocellular Carcinoma AJCC v8Unresectable Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (3)

  • 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

Study Arms (1)

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.

Procedure: Computed TomographyDrug: Gallium Ga 68 GozetotideProcedure: Positron Emission Tomography

Interventions

Gallium Ga 68 GozetotideDRUG

Undergo 68Ga PSMA PET/CT

Also known as: (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
Treatment (68GA PSMA PET/CT)
Computed TomographyPROCEDURE

Undergo 68Ga PSMA PET/CT

Also known as: CAT, CAT Scan, Computed Axial Tomography, Computerized Axial Tomography, Computerized Tomography, CT, CT Scan, tomography
Treatment (68GA PSMA PET/CT)
Positron Emission TomographyPROCEDURE

Undergo 68Ga PSMA PET/CT

Also known as: Medical Imaging, Positron Emission Tomography, PET, PET Scan, Positron Emission Tomography Scan, Positron-Emission Tomography, proton magnetic resonance spectroscopic imaging, PT
Treatment (68GA PSMA PET/CT)

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

gallium 68 PSMA-1168Ga-DKFZ-PSMA-11Magnetic Resonance Spectroscopy

Condition Hierarchy (Ancestors)

AdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeNeoplasmsLiver NeoplasmsDigestive System NeoplasmsNeoplasms by SiteDigestive System DiseasesLiver Diseases

Intervention Hierarchy (Ancestors)

Spectrum AnalysisChemistry Techniques, AnalyticalInvestigative Techniques

Study Officials

  • Nguyen H. Tran, MD

    Mayo Clinic in Rochester

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 22, 2021

First Posted

January 4, 2022

Study Start

January 30, 2022

Primary Completion

December 31, 2025

Study Completion

December 31, 2025

Last Updated

February 5, 2026

Record last verified: 2026-02

Locations

US(1)