68 Ga PSMA PET/MRI for Hepatocellular Carcinoma

Hepatocellular Carcinoma Clinical Trial

Official title:

Pilot Study of Integrated Time-of-Flight (TOF) 68 GA-PSMA - Gadoxetate PET/MR for Evaluation of Hepatocellular Carcinoma

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03982407
• Other study ID #: 18-011263
• Secondary ID: NCI-2019-08426MC
• Status: Completed
• Phase: Early Phase 1
• Start date: June 27, 2019
• Est. completion date: April 6, 2022

Study information

• Verified date: July 2022
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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

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:

1. To demonstrate the feasibility of 68Ga-PSMA-PET/MRI for imaging patients with HCC

2. To estimate the sensitivity of SUVmax on PSMA PET for identification of LI-RADS® 5 (definitely HCC) observations or biopsy proven HCC(s).

3. 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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 5
• Est. completion date: April 6, 2022
• Est. primary completion date: May 5, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Carcinoma
• Carcinoma, Hepatocellular
• Hepatocellular Carcinoma

Intervention

Drug:
• 68Ga-PSMA-11 PET/MRI
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.

Locations

Country	Name	City	State
United States	Mayo Clinic in Rochester	Rochester	Minnesota

Sponsors (1)

Lead Sponsor	Collaborator
Ajit H. Goenka, MD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	18 months

External Links

•   Mayo Clinic Clinical Trials