Clinical Application of 68Ga-PSMA PET/MR for Diagnosis and Staging in Hepatocellular Carcinoma

February 13, 2023 updated by: Xiaoli Lan, Wuhan Union Hospital, China

A Prospective Study of Clinical Application of 68Ga-PSMA PET/MR for Diagnosis and Staging in Hepatocellular Carcinoma

In this prospective study, 68Ga-PSMA integrated PET/MR imaging was applied for the diagnosis and staging of hepatocellular carcinoma (HCC). The detection and diagnostic performance of 68Ga-PSMA PET/MR for HCC was evaluated in comparison with the gold standard of puncture biopsy or postoperative pathology. The aim is to make up for the deficiency in FDG PET imaging in the diagnosis and staging of HCC.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Hepatocellular carcinoma (HCC) is one of the most dangerous malignancies in human health, with the sixth highest incidence of malignant tumors. However, early diagnosis of HCC is difficult. The currently used glucose metabolism imaging agent, 18F-FDG, also accumulates in large amounts in normal liver tissue, which affects the diagnosis of HCC lesions.

Prostate specific membrane antigen (PSMA), a type II transmembrane glycoprotein encoded by the FOLH1 gene, is highly expressed in prostate epithelial cells and has been widely used in the study of prostate cancer. Further studies have found that it is involved in tumor angiogenesis in a variety of solid tumors of non-prostate tissue origin. It is also overexpressed in neovascular endothelial cells of hepatocellular carcinoma, which is significantly associated with tumor grading, staging and prognosis. Moreover, PSMA also has great potential as a target for anti-vascular therapy.

The integrated PET/MR is currently the most advanced imaging device, combining the advantages of PET and MR, with the high sensitivity of PET and the high soft tissue contrast of MR. It has significant advantages over PET/CT in head and neck, abdominopelvic lesions. And MR imaging has no additional radiation and a higher biosafety profile.

In view of the potential of 68Ga-PSMA for HCC imaging, this prospective study proposes to apply 68Ga-PSMA integrated PET/MR imaging for diagnosis and staging of HCC. The detection and diagnostic performance of 68Ga-PSMA PET/MR for HCC was evaluated in comparison with the gold standard of biopsy or postoperative pathology. The aim is to make up for the deficiency in FDG PET imaging in the diagnosis and staging of HCC.

Study Type

Interventional

Enrollment (Anticipated)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Hubei
      • Wuhan, Hubei, China, 430022
        • Recruiting
        • China, Hubei Province

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Each subject must meet all the inclusion criteria to be eligible for the study.

  • Subjects or their legal representatives are able to sign an informed consent form
  • Subjects are committed to comply with the study procedures and cooperate with the implementation of the full study
  • Subjects are 18 years of age or older, regardless of gender
  • Subjects with high suspicion of HCC, or diagnosed HCC without tumour-related treatment (supporting evidence including serum AFP, MRI, CT and other imaging data and histopathology), and in good general condition
  • Subjects intend to obtain pathological results by biopsy or surgical resection

Exclusion Criteria:

All patients meeting any of the exclusion criteria will be excluded from the study.

  • Patients or their legal representatives are unable or unwilling to sign the informed consent form
  • Patients are unable to cooperate in the conduct of the full study
  • Patients with acute systemic illness and electrolyte disturbances
  • Patients with other previous malignancies or a combination of other malignancies
  • Patients who are pregnant or lactating women

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 68Ga-PSMA PET/MR
The investigators selected patients with a high clinical suspicion of HCC, or patients with confirmed HCC without tumour-related treatment who were to be biopsied or surgically resected to obtain pathological results. Patients signed an informed consent form and underwent 68Ga-PSMA PET/MR imaging (or PET/CT imaging if the patient had a contraindication to MR imaging).
Device: PET/MR
Each subject undergoes PET/MR imaging within 40-60 minutes after injection.
Other Names:
  • Positron Emission Tomography/Magnetic Resonance
Device: PET/CT
Each subject undergoes PET/CT imaging within 40-60 minutes after injection.
Other Names:
  • Positron Emission Tomography/Computed Tomography
Drug: 68Ga-PSMA
Intravenous access is established in advance, intravenous bolus injection, 68Ga-PSMA dose is about 1.85-3.7 MBq/kg body weight (0.05-0.1 mCi/kg). Patients were encouraged to drink water after injection and asked to empty their bladder before PET scan.
Other Names:
  • gallium-68 (68Ga)-prostate specific membrane antigen (PSMA)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Sensitivity and specificity of 68Ga-PSMA PET/MR for diagnosis and staging in hepatocellular carcinoma.
Time Frame: 1 year
For patients without any treatment, the initial diagnosis and staging results of 68Ga-PSMA PET/MR (PET/CT) will be compared with pathological, clinical and follow-up results.
1 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Correlation of 68Ga-PSMA uptake in HCC patients with PSMA expression levels in tissues.
Time Frame: 1 year
PSMA-related immunohistochemical staining and quantification of PSMA expression was performed on biopsy/surgical tissue sections from patients. The investigators analysed the correlation between HCC 68Ga-PSMA uptake and PSMA expression levels in tissues.
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Wuhan Union Hospital, China

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

August 16, 2021

Primary Completion (ANTICIPATED)

December 31, 2023

Study Completion (ANTICIPATED)

December 31, 2023

Study Registration Dates

First Submitted

August 7, 2021

First Submitted That Met QC Criteria

August 7, 2021

First Posted (ACTUAL)

August 16, 2021

Study Record Updates

Last Update Posted (ESTIMATE)

February 14, 2023

Last Update Submitted That Met QC Criteria

February 13, 2023

Last Verified

February 1, 2022

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • XLan-0606-01

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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