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

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Primary Purpose

Status

Recruiting

Phase

Early Phase 1

Locations

United States

Study Type

Interventional

Intervention

Gallium Ga 68 Gozetotide

Hepatic Artery Embolization

Positron Emission Tomography and Computed Tomography Scan

About this trial

This is an interventional diagnostic trial for Hepatocellular Carcinoma

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

Mayo Clinic in RochesterRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

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

Arm 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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

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.

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.

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

Incidence of adverse events

Full Information

NCT ID

NCT05111314

First Posted

October 27, 2021

Last Updated

January 11, 2023

Sponsor

Mayo Clinic

1. Study Identification

Unique Protocol Identification Number

NCT05111314

Brief Title

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

2. Study Status

Record Verification Date

January 2023

Overall Recruitment Status

Recruiting

Study Start Date

February 11, 2022 (Actual)

Primary Completion Date

November 1, 2023 (Anticipated)

Study Completion Date

November 1, 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Mayo Clinic

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

No

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Hepatocellular Carcinoma

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Early Phase 1

Interventional Study Model

Single Group Assignment

Masking

None (Open Label)

Allocation

N/A

Enrollment

10 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

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

Arm Type

Experimental

Arm 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.

Intervention Type

Radiation

Intervention Name(s)

Gallium Ga 68 Gozetotide

Other Intervention Name(s)

(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

Intervention Description

Given IA

Intervention Type

Procedure

Intervention Name(s)

Hepatic Artery Embolization

Intervention Description

Undergo hepatic artery embolization

Intervention Type

Procedure

Intervention Name(s)

Positron Emission Tomography and Computed Tomography Scan

Other Intervention Name(s)

PET-CT Scan, PET/CT SCAN, Positron Emission Tomography/Computed Tomography

Intervention Description

Undergo PET/CT scan

Primary Outcome Measure Information:

Title

Intraindividual intralesional difference in maximum standardized uptake value (SUVmax)

Description

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.

Time Frame

Up to 2 years

Secondary Outcome Measure Information:

Title

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

Description

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.

Time Frame

Up to 2 years

Title

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.

Description

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

Time Frame

Up to 2 years

Title

Incidence of adverse events

Time Frame

Up to 2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

No

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

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Scott M Thompson

Organizational Affiliation

Mayo Clinic in Rochester

Official's Role

Principal Investigator

Facility Information:

Facility Name

Mayo Clinic in Rochester

City

Rochester

State/Province

Minnesota

ZIP/Postal Code

55905

Country

United States

Individual Site Status

Recruiting

Facility Contact:

First Name & Middle Initial & Last Name & Degree

Clincial Trials Referral Office

Phone

855-776-0015

Email

mayocliniccancerstudies@mayo.edu

First Name & Middle Initial & Last Name & Degree

Scott M. Thompson, M.D., Ph.D.

Hepatocellular Carcinoma

About this trial

Eligibility Criteria

Sites / Locations

Arms of the Study

Arm 1

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

1. Study Identification

2. Study Status

3. Sponsor/Collaborators

4. Oversight

5. Study Description

6. Conditions and Keywords

7. Study Design

8. Arms, Groups, and Interventions

10. Eligibility

12. IPD Sharing Statement

Learn more about this trial