Clinical Application of 68Ga-PSMA PET/MR for Diagnosis and Staging in Hepatocellular Carcinoma
NCT ID: NCT05006326
Last Updated: 2023-02-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
30 participants
INTERVENTIONAL
2021-08-16
2023-12-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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NA
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
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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).
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.
PET/MR
Each subject undergoes PET/MR imaging within 40-60 minutes after injection.
PET/CT
Each subject undergoes PET/CT imaging within 40-60 minutes after injection.
Interventions
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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.
PET/MR
Each subject undergoes PET/MR imaging within 40-60 minutes after injection.
PET/CT
Each subject undergoes PET/CT imaging within 40-60 minutes after injection.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
* 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
18 Years
80 Years
ALL
No
Sponsors
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Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
OTHER
Responsible Party
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Xiaoli Lan
Director of the Department of nuclear medicine
Principal Investigators
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Xiaoli Lan, PhD
Role: STUDY_DIRECTOR
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Locations
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China, Hubei Province
Wuhan, Hubei, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
Other Identifiers
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XLan-0606-01
Identifier Type: -
Identifier Source: org_study_id
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