Comparison of Hepatic Intraarterial Versus Systemic Intravenous 68Ga-PSMA PET/CT for Detection of Hepatocellular Carcinoma

November 3, 2023 updated by: Scott M. Thompson, Mayo Clinic

Intraindividual Comparison of Hepatic Intraarterial Versus Systemic Intravenous 68Ga-PSMAPET/CT in Patients With HCC: Pilot Study

This phase 0/1 study evaluates intraarterial administration of gallium Ga 68 gozetotide (68Ga-PSMA) for the detection of prostate-specific membrane antigen (PSMA) positive liver cancer by positron emission tomography (PET)/computed tomography (CT). 68Ga-PSMA is an imaging agent used with PET/CT scans to locate PSMA positive lesions. This study evaluates intraarterial administration of this agent, compared to intravenous administration.

Study Overview

Status

Withdrawn

Conditions

Intervention / Treatment

Detailed Description

PRIMARY OBJECTIVE:

I. To determine the tumor radiotracer uptake (first pass effect or regional advantage) of direct hepatic intraarterial (I.A.) versus systemic intravenous (I.V.) 68Ga-PSMA in patients with PSMA+ hepatocellular carcinoma (HCC) by PET/CT.

OUTLINE:

Patients undergoing clinically indicated hepatic artery embolization will receive 68Ga-PSMA intraarterially (IA) over 5 minutes. After 60-90 minutes, patients undergo PET/CT scan over 1 hour.

Study Type

Interventional

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Minnesota
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic in Rochester

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Patients with either an imaging diagnosis of HCC by CT or magnetic resonance imaging (MRI) (Liver Imaging and Reporting Data System 5 [LI-RADS 5]) confirmed by a board-certified abdominal radiologist, or with biopsy-proven HCC
  • Already enrolled in ongoing Transform the Practice or Department of Defense 68Ga-PSMA studies
  • PSMA avid HCC detected by 68Ga-PSMA PET/CT after intravenous administration of 68Ga-PSMA confirmed by a board certified nuclear radiologist
  • Undergoing planned hepatic artery embolization (HAE) per standard clinical care
  • Male or female with age greater than 18 years, with the capacity and willingness to provide a written informed consent

Exclusion Criteria:

  • Subjects requiring emergent surgery for a ruptured/bleeding HCC
  • Pregnant and/or breast-feeding subjects. A negative pregnancy test within 48 hours of the PET scan
  • Subjects with higher than the weight/size limitations of PET/CT scanner

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Diagnostic (embolization, 68Ga-PSMA, PET/CT)
Patients undergoing clinically indicated hepatic artery embolization will receive 68Ga-PSMA intraarterially (IA) over 5 minutes. After 60-90 minutes, patients undergo PET/CT scan over 1 hour.
Radiation: Gallium Ga 68 Gozetotide
Given IA
Other Names:
  • (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
Procedure: Hepatic Artery Embolization
Undergo hepatic artery embolization
Procedure: Positron Emission Tomography and Computed Tomography Scan
Undergo PET/CT scan
Other Names:
  • PET-CT Scan
  • PET/CT SCAN
  • Positron Emission Tomography/Computed Tomography

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Intraindividual intralesional difference in maximum standardized uptake value (SUVmax)
Time Frame: Up to 2 years
Intraindividual intralesional difference in maximum standardized uptake value (SUVmax) will be evaluated as fold change and absolute difference for a given lesion between intra-arterially (I.A.) and intravenous (I.V.) prostate-specific membrane antigen (PSMA) positron emission tomography (PET). Qualitative evaluation assesses the intensity of PSMA uptake in hepatic lesions, graded as follows: grade 1: uptake < normal liver; grade 2: uptake = normal liver; grade 3: uptake > normal liver; grade 4: uptake > spleen or kidneys. Semi-quantitative analysis is undertaken by calculating intraindividual difference in SUVmax for each lesion between I.A. and I.V. PSMA PET followed by a two-sided one sample t-test. Maximum and mean standardized uptake value (SUVmax, SUVmean, SUVmin) of the lesion(s), and SUVmax of the background liver are noted.
Up to 2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Incidence of adverse events
Time Frame: Up to 2 years
Up to 2 years
Intraindividual intralesional differences in tumor to background (TBR) of SUVmax
Time Frame: Up to 2 years
For each lesion, tumor-to-liver background ratio (TBR) of SUVmax will be calculated and the intraindividual intralesional difference in TBR of SUVmax will be compared on a lesion basis between I.A. and I.V. PSMA PET.
Up to 2 years
Difference in PSMA uptake measured by SUVmax (fold change, absolute difference) in the kidneys, spleen and salivary glands between I.A. and I.V. PSMA PET.
Time Frame: Up to 2 years
SUVmax will be measured for the kidneys, spleen and salivary glands and the difference in PSMA uptake measured by SUVmax (fold change, absolute difference) in the kidneys, spleen and salivary glands will be compared between I.A. and I.V. PSMA PET
Up to 2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Mayo Clinic

Investigators

  • Principal Investigator: Scott M Thompson, Mayo Clinic in Rochester

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 11, 2022

Primary Completion (Actual)

August 14, 2023

Study Completion (Actual)

August 14, 2023

Study Registration Dates

First Submitted

October 27, 2021

First Submitted That Met QC Criteria

October 27, 2021

First Posted (Actual)

November 8, 2021

Study Record Updates

Last Update Posted (Actual)

November 7, 2023

Last Update Submitted That Met QC Criteria

November 3, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 21-004930
  • NCI-2021-11290 (Registry Identifier: CTRP (Clinical Trial Reporting Program))

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

Yes

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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