68 Ga PSMA PET/MRI for Hepatocellular Carcinoma

NCT03982407 | Completed Early Phase 1 DMC FDA Drug

• 3 other identifiers: 18-011263NCI-2019-08426MC1944
• Study Type: interventional
• Target: 5
• Locations: 1 country
• Sites: 1

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

Conditions

Hepatocellular Carcinoma

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Ga68 PSMA PET-MR

EXPERIMENTAL

68Ga labeled PSMA -11 (or PSMA-HBED\_CC) PET/MRI scan

Drug: 68Ga-PSMA-11 PET/MRI

Interventions

68Ga-PSMA-11 PET/MRI DRUG

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.

Ga68 PSMA PET-MR

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Ajit H. Goenka, MD: lead

Study Sites (1)

Mayo Clinic in Rochester

Rochester, Minnesota, 55905, United States

Location

Related Links

• Mayo Clinic Clinical Trials

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Study Officials

• Ajit H Goenka, MD

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 5, 2019
• First Posted: June 11, 2019
• Study Start: June 27, 2019
• Primary Completion: May 5, 2021
• Study Completion: April 6, 2022
• Last Updated: July 20, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)