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

Mayo Clinic

Status and phase: Withdrawn; Early Phase 1

Conditions: Hepatocellular Carcinoma

Treatments: Procedure: Positron Emission Tomography and Computed Tomography Scan; Procedure: Hepatic Artery Embolization; Radiation: Gallium Ga 68 Gozetotide

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT05111314

NCI-2021-11290 (Registry Identifier)

21-004930 (Other Identifier)

Details and patient eligibility

About

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.

Full 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.

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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0 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Procedure: Hepatic Artery Embolization

Radiation: Gallium Ga 68 Gozetotide

Procedure: Positron Emission Tomography and Computed Tomography Scan