Study on the Clinical Application Value of PET Imaging Targeting GPC3 in Hepatocellular Carcinoma

Trial Title: Study on the Clinical Application Value of PET Imaging Targeting GPC3 in Hepatocellular Carcinoma

NCT ID: NCT06383520

Condition: Malignant Neoplasm of Liver

Conditions: Official terms:
Carcinoma, Hepatocellular
Neoplasms
Liver Neoplasms

Study type: Interventional

Study phase: Early Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Drug
Intervention name: 68Ga-aGPC3-scFv/Fab
Description: For pharmacokinetics, healthy volunteer underwent PET imaging targeting GPC3. Blood samples were collected at 25 min, 55 min, and 115 min after imaging agent injection, and urine specimens were collected at 28 min, 58 min, and 118 min after injection to measure radioactivity in blood and urine. PET/MR scans were performed at 30-50 min, 60-80 min, and 120-140 min after injection to understand absorption, distribution, and metabolism. For Cancer patients, subjects should have targeting GPC3 and 18F-FDG PET scans two days apart. Blood tests, liver and kidney function, tumor markers (AFP, etc.), and other biochemical markers must be performed one week prior to and after imaging. Tumor biopsies or surgical specimens should be evaluated histopathologically and immunostained for biomarkers associated with angiogenesis.
Arm group label: PET imaging targeting GPC3 in hepatocellular carcinoma

Other name: gallium-68(68Ga)-aGPC3-scFv/Fab

Summary: This is a diagnostic study. Patients were recruited from patients with clinically suspected or confirmed hepatocellular carcinoma and healthy volunteers were recruited for PET/or PET/CT imaging targeting a GPC3-specific probe (in the case of 68Ga-NOTA-aGPC3-scFv) , to observe the reaction of volunteers and patients after injection of drugs, to evaluate the pharmacokinetics in vivo and the efficacy of diagnosis and staging, and to perform PET CT imaging in patients with contraindications. General Information, clinical data, blood routine, liver and renal function, and other imaging data were collected. The final diagnosis was based on the histopathology of biopsy or surgical specimens.

Detailed description: Liver cancer is one of the most common malignant tumors in the world, and hepatocellular carcinoma (HCC) is the most prominent histopathological type. Surgical resection and liver transplantation are the main radical methods for early HCC patients. However, due to its insidious onset, more than 90% of HCC patients are already in local advanced stage or accompanied by distant metastasis when diagnosed, so there is no surgical opportunity and the prognosis is very poor. It is important to explore new methods and strategies for early and accurate diagnosis of HCC to improve the prognosis of patients. Traditional imaging methods such as multi-temporal computed tomography (CT) and magnetic resonance imaging (MRI) have been widely used in the diagnosis, staging and treatment decision making of HCC, but qualitative diagnosis cannot be achieved. Nuclear medicine diagnostic tool [18F]-Fluorodeoxyglucose positron emission tomography/computed tomography ([18F]-FDG PET/CT) imaging technology has been widely used in the diagnosis of a variety of malignant tumors, but due to its low diagnostic accuracy for HCC, especially highly differentiated HCC, its value in the early diagnosis of HCC is limited. GPC3, a member of the heparan sulfate glycoprotein family, is composed of a core protein, two heparan sulfate chains located at the C-terminal and phosphatidyl inositol anchors attached to the cell membrane. Data analysis showed that GPC3 was significantly overexpressed in tumor cells of HCC patients, but hardly expressed in normal liver tissue or in benign liver diseases, making it the most specific tumor marker for HCC. High expression of GPC3 is associated with poor prognosis in HCC. patients,.suggesting that GPC3 may be an important molecular target for accurate diagnosis and treatment of HCC. This project proposes to PET imaging targeting GPC3 in the diagnosis and staging of HCC and to compare the diagnostic efficacy with the pathology gold standard. And this study was conducted to compensate for the lack of value of 18F-FDG PET imaging for the diagnosis and staging of malignant tumors by comparing PET imaging targeting GPC3 with the commonly used 18F-FDG PET imaging.

Criteria for eligibility:
Criteria:
Inclusion Criteria: - 1: Voluntarily participate and the person or their legal representative can sign an informed consent form - 2: Adult patients (18 years of age or older), regardless of gender - 3: Patients with newly diagnosed hepatocellular carcinoma with high clinical suspicion or confirmation (supporting evidence including imaging data and histopathologic examination, etc.) who agree to undergo histopathologic examination (if not performed prior to imaging) or/and 18F-FDG PET imaging - 4: Healthy volunteer - 5: Patients with a history of hepatocellular carcinoma, remission and recurrence after treatment - 6: Willing and able to follow schedule visits, treatment plans and laboratory tests Exclusion Criteria: - 1: Pregnant or lactating patients - 2: The patient or their legal representative is unable or unwilling to sign the informed consent form - 3: Acute systemic diseases and electrolyte disorders - 4: Patients who are known to be allergic to GPC3 imaging agents or synthetic excipients - 5: Fasting blood glucose levels exceeding 11.0 mmol/L before injection of 18F-FDG - 6: Individuals who are unable to complete PET/MR or PET/CT examinations (including inability to lie flat, claustrophobia, radiation phobia, etc.) - 7: Researchers believe that compliance is poor or there are other unfavorable factors for participating in this experiment

Gender: All

Minimum age: 18 Years

Maximum age: 65 Years

Healthy volunteers: Accepts Healthy Volunteers

Locations:

Facility:
Name: China, Hubei Province

Address:
City: Wuhan
Zip: 430022
Country: China

Status: Recruiting

Contact:
Last name: Xiaoli Lan, PhD

Phone: +86-027-83692633
Email: lxl730724@hotmail.com

Start date: September 30, 2023

Completion date: December 2025

Lead sponsor:
Agency: Wuhan Union Hospital, China
Agency class: Other

Source: Wuhan Union Hospital, China

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06383520