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

NCT05111314 | Withdrawn Early Phase 1 DMC FDA Drug

• 2 other identifiers: 21-004930NCI-2021-11290
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• Intraindividual intralesional difference in maximum standardized uptake value (SUVmax)

  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 Outcomes (3)

• Intraindividual intralesional differences in tumor to background (TBR) of SUVmax

  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.

  Up to 2 years

• Incidence of adverse events

  Up to 2 years

Study Arms (1)

Diagnostic (embolization, 68Ga-PSMA, PET/CT)

EXPERIMENTAL

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; Procedure: Hepatic Artery Embolization; Procedure: Positron Emission Tomography and Computed Tomography Scan

Interventions

Gallium Ga 68 Gozetotide RADIATION

Given IA

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

Diagnostic (embolization, 68Ga-PSMA, PET/CT)

Hepatic Artery Embolization PROCEDURE

Undergo hepatic artery embolization

Diagnostic (embolization, 68Ga-PSMA, PET/CT)

Positron Emission Tomography and Computed Tomography Scan PROCEDURE

Undergo PET/CT scan

Also known as: PET-CT Scan, PET/CT SCAN, Positron Emission Tomography/Computed Tomography

Diagnostic (embolization, 68Ga-PSMA, PET/CT)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Mayo Clinic: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Interventions

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

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Intervention Hierarchy (Ancestors)

Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques

Study Officials

• Scott M Thompson

  Mayo Clinic in Rochester

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: October 27, 2021
• First Posted: November 8, 2021
• Study Start: February 11, 2022
• Primary Completion: August 14, 2023
• Study Completion: August 14, 2023
• Last Updated: November 7, 2023

Record last verified: 2023-11

Locations

US (1)