RecruitingEarly Phase 1NCT06383520

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

Sponsor

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

Enrollment

100 participants

Start Date

Sep 30, 2023

Study Type

INTERVENTIONAL

Conditions

Malignant Neoplasm of Liver

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.

Eligibility

Min Age: 18 YearsMax Age: 65 Years

Plain Language Summary

Simplified for easier understanding

This study is testing a new type of PET scan imaging that targets a protein called GPC3, which is found on liver cancer cells, to see if it can better detect and monitor hepatocellular carcinoma (liver cancer). **You may be eligible if...** - You are 18 or older - You have been newly diagnosed with suspected or confirmed liver cancer - OR you are a healthy volunteer - OR you have a history of liver cancer and it has come back - You are willing to follow the study schedule **You may NOT be eligible if...** - You are pregnant or breastfeeding - You have uncontrolled blood sugar (glucose above 11.0 mmol/L before the scan) - You are allergic to the imaging agent - You cannot lie flat or have severe claustrophobia - You have serious active illness or severe electrolyte problems Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DRUG68Ga-aGPC3-scFv/Fab

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.

Locations(1)

China, Hubei Province

Wuhan, Hubei, China

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NCT06383520