Clinical trial NCT05111314: Comparison of Hepatic Intraarterial Versus Systemic Intravenous 68Ga-PSMA PET/CT for Detection of Hepatocellular Carcinoma
Official title: Intraindividual Comparison of Hepatic Intraarterial Versus Systemic Intravenous 68Ga-PSMAPET/CT in Patients With HCC: Pilot Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: EARLY_PHASE1
Conditions: Hepatocellular Carcinoma
Lead sponsor: Mayo Clinic
Sponsor class: OTHER
First posted: 2021-11-08
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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.

Eligibility criteria: 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

Primary outcomes:
measure: Intraindividual intralesional difference in maximum standardized uptake value (SUVmax)
timeFrame: Up to 2 years
Secondary outcomes:
measure: Intraindividual intralesional differences in tumor to background (TBR) of SUVmax
timeFrame: Up to 2 years
measure: 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.
timeFrame: Up to 2 years
measure: Incidence of adverse events
timeFrame: Up to 2 years
Other outcomes:
Locations:
city: Rochester
country: United States
facility: Mayo Clinic in Rochester
state: Minnesota
Study officials:
affiliation: Mayo Clinic in Rochester
name: Scott M Thompson
role: PRINCIPAL_INVESTIGATOR
References: