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68 Ga PSMA PET/MRI for Hepatocellular Carcinoma

Primary Purpose

Hepatocellular Carcinoma

Status
Completed
Phase
Early Phase 1
Locations
United States
Study Type
Interventional
Intervention
68Ga-PSMA-11 PET/MRI
Sponsored by
Ajit H. Goenka, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

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 at risk for HCC with either an imaging diagnosis of HCC by ceCT or ceMRI (LI-RADS 5) confirmed by a board-certified abdominal radiologist or biopsy-proven HCC confirmed by a hepatobiliary pathologist
  • No prior treatment for HCC
  • Subjects who are expected to undergo surgical resection of the hepatic lesion(s) and/or liver transplant
  • Male or female with age greater than 18 years, with the capacity to give informed consent and willingness to provide a written consent.

Exclusion Criteria:

  • Subjects requiring emergent surgery for a ruptured/bleeding HCC
  • Bilirubin > 3.0 mg/dL, which is a contraindication for Gadoxetate, the MRI contrast agent
  • 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/MRI scanner.
  • Subjects with contraindication to MRI including: Subjects who have a heart pacemaker, subjects who have a metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain, subjects who have implanted devices with magnets, subjects who have other implanted electronic devices, subjects who have deep brain stimulator, subjects who have vagal nerve stimulator, subjects with cochlear (ear) or auditory implants
  • Subjects with history of allergic response to radiocontrast media
  • Subjects with known history of claustrophobia.

Sites / Locations

  • Mayo Clinic in Rochester

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Ga68 PSMA PET-MR

Arm Description

68Ga labeled PSMA -11 (or PSMA-HBED_CC) PET/MRI scan

Outcomes

Primary Outcome Measures

Evaluation of PSMA PET-MR for identification of intra and extrahepatic hepatocellular carcinoma in patients
Sensitivity of PSMA PET-MRI for detection of LI-RADS 5 (definitely HCC) lesions on a per-lesion basis with histopathology as the gold standard. We will perform a Radiologic-pathologic correlation comparing HCC PSMA SUVmax with tumor PSMA immunostaining positivity.

Secondary Outcome Measures

Full Information

First Posted
June 5, 2019
Last Updated
July 18, 2022
Sponsor
Ajit H. Goenka, MD
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1. Study Identification

Unique Protocol Identification Number
NCT03982407
Brief Title
68 Ga PSMA PET/MRI for Hepatocellular Carcinoma
Official Title
Pilot Study of Integrated Time-of-Flight (TOF) 68 GA-PSMA - Gadoxetate PET/MR for Evaluation of Hepatocellular Carcinoma
Study Type
Interventional

2. Study Status

Record Verification Date
July 2022
Overall Recruitment Status
Completed
Study Start Date
June 27, 2019 (Actual)
Primary Completion Date
May 5, 2021 (Actual)
Study Completion Date
April 6, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Ajit H. Goenka, MD

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 is a pilot study to investigate the evaluate to use of a drug/radiopharmaceutical called Gallium-68 PSMA-11 (68Ga-PSMA-11) for use in PET/MRI evaluation of hepatocellular carcinoma
Detailed Description
This is a prospective pilot proof-of-concept single-center study. Primary Objective Using surgical histopathology as the reference standard, the investigators intend to achieve the following objectives in adult subjects with Hepatocellular Carcinoma (HCC) undergoing surgical resection or transplant: To demonstrate the feasibility of 68Ga-PSMA-PET/MRI for imaging patients with HCC To estimate the sensitivity of SUVmax on PSMA PET for identification of LI-RADS® 5 (definitely HCC) observations or biopsy proven HCC(s). To perform a Radiology-Pathology correlation of PSMA uptake at PET with HCC tumor PSMA immunostaining, tumor pathology features, and signal and enhancement characteristics at MRI

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
5 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Ga68 PSMA PET-MR
Arm Type
Experimental
Arm Description
68Ga labeled PSMA -11 (or PSMA-HBED_CC) PET/MRI scan
Intervention Type
Drug
Intervention Name(s)
68Ga-PSMA-11 PET/MRI
Intervention Description
The PET/MRI exam-related patient visit will last approximately 2 to 2.5 hours, including 30-minute nursing assessment, 45-60 minutes for PSMA uptake and 60 minutes for PET/MRI scan. They will be contacted within the next 72 hours to complete a brief phone survey.
Primary Outcome Measure Information:
Title
Evaluation of PSMA PET-MR for identification of intra and extrahepatic hepatocellular carcinoma in patients
Description
Sensitivity of PSMA PET-MRI for detection of LI-RADS 5 (definitely HCC) lesions on a per-lesion basis with histopathology as the gold standard. We will perform a Radiologic-pathologic correlation comparing HCC PSMA SUVmax with tumor PSMA immunostaining positivity.
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Patients at risk for HCC with either an imaging diagnosis of HCC by ceCT or ceMRI (LI-RADS 5) confirmed by a board-certified abdominal radiologist or biopsy-proven HCC confirmed by a hepatobiliary pathologist No prior treatment for HCC Subjects who are expected to undergo surgical resection of the hepatic lesion(s) and/or liver transplant Male or female with age greater than 18 years, with the capacity to give informed consent and willingness to provide a written consent. Exclusion Criteria: Subjects requiring emergent surgery for a ruptured/bleeding HCC Bilirubin > 3.0 mg/dL, which is a contraindication for Gadoxetate, the MRI contrast agent 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/MRI scanner. Subjects with contraindication to MRI including: Subjects who have a heart pacemaker, subjects who have a metallic foreign body (metal sliver) in their eye, or who have an aneurysm clip in their brain, subjects who have implanted devices with magnets, subjects who have other implanted electronic devices, subjects who have deep brain stimulator, subjects who have vagal nerve stimulator, subjects with cochlear (ear) or auditory implants Subjects with history of allergic response to radiocontrast media Subjects with known history of claustrophobia.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ajit H Goenka, MD
Organizational Affiliation
Mayo Clinic
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

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
https://www.mayo.edu/research/clinical-trials
Description
Mayo Clinic Clinical Trials

Learn more about this trial

68 Ga PSMA PET/MRI for Hepatocellular Carcinoma

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