Malignant Neoplasm
Conditions
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.
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.
Interventions
DRUG68Ga-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.
DEVICEPET/MR
Each subject undergoes PET/MR imaging within 40-60 minutes after injection.
DEVICEPET/CT
Each subject undergoes PET/CT imaging within 40-60 minutes after injection.
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Sensitivity and specificity of 68Ga-PSMA PET/MR for diagnosis and staging in hepatocellular carcinoma. | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Correlation of 68Ga-PSMA uptake in HCC patients with PSMA expression levels in tissues. | 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. |
Countries
China
Contacts
Primary ContactXiaoli Lan, PhD
Outcome results
None listed