Intraindividual Comparison of Hepatic Intraarterial Versus Systemic Intravenous 68Ga-PSMAPET/CT in Patients With HCC: Pilot Study
Trial Snapshot
- Phase
- Early Phase 1
- Status
- Withdrawn
- Sponsor
- Mayo Clinic
- Locations
- 2
- Primary Endpoint
- Intraindividual intralesional difference in maximum standardized uptake value (SUVmax)
Study Overview
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.
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Diagnostic
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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
Outcomes
Primary Outcomes
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.
Secondary Outcomes
- Incidence of adverse events(Up to 2 years)
- 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)
Investigators
Scott M. Thompson
Principal Investigator
Mayo Clinic