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

NCT05006326 | Unknown

• 1 other identifier: XLan-0606-01
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Malignant Neoplasm

Outcome Measures

Primary Outcomes (1)

• Sensitivity and specificity of 68Ga-PSMA PET/MR for diagnosis and staging in hepatocellular carcinoma.

  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 Outcomes (1)

• Correlation of 68Ga-PSMA uptake in HCC patients with PSMA expression levels in tissues.

  1 year

Study Arms (1)

68Ga-PSMA PET/MR

EXPERIMENTAL

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).

Drug: 68Ga-PSMA; Device: PET/MR; Device: PET/CT

Interventions

68Ga-PSMA DRUG

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.

Also known as: gallium-68 (68Ga)-prostate specific membrane antigen (PSMA)

68Ga-PSMA PET/MR

PET/MR DEVICE

Each subject undergoes PET/MR imaging within 40-60 minutes after injection.

Also known as: Positron Emission Tomography/Magnetic Resonance

68Ga-PSMA PET/MR

PET/CT DEVICE

Each subject undergoes PET/CT imaging within 40-60 minutes after injection.

Also known as: Positron Emission Tomography/Computed Tomography

68Ga-PSMA PET/MR

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Union Hospital, Tongji Medical College, Huazhong University of Science and Technology: lead

Study Sites (1)

China, Hubei Province

Wuhan, Hubei, 430022, China

RECRUITING

Related Publications (1)

• Qin C, Song X, Sun S, Song Y, Ruan W, Gai Y, Yang M, Wan C, Lan X. [68Ga]Ga-PSMA-617 PET/MRI for imaging patients suspected of hepatocellular carcinoma. Eur J Nucl Med Mol Imaging. 2025 Mar;52(4):1278-1290. doi: 10.1007/s00259-024-06973-7. Epub 2024 Nov 21.

  PMID: 39570398 DERIVED

MeSH Terms

Conditions

Neoplasms

Interventions

gallium 68 PSMA-11; Gallium-68; Positron-Emission Tomography; Magnetic Resonance Spectroscopy; Positron Emission Tomography Computed Tomography

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope; Spectrum Analysis; Chemistry Techniques, Analytical; Investigative Techniques; Tomography, X-Ray Computed; Multimodal Imaging; Radiographic Image Enhancement; Radiography; Tomography, X-Ray

Study Officials

• Xiaoli Lan, PhD

  Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

  STUDY DIRECTOR

Central Study Contacts

Xiaoli Lan, PhD

CONTACT

0086-027-83692633; lxl730724@hotmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of the Department of nuclear medicine

Study Record Dates

• First Submitted: August 7, 2021
• First Posted: August 16, 2021
• Study Start: August 16, 2021
• Primary Completion: December 31, 2023
• Study Completion: December 31, 2023
• Last Updated: February 14, 2023

Record last verified: 2022-02

Locations

CN (1)