NCT06383520|RecruitingEarly Phase 1
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Sponsor study identifier
interventional
100
1 country
1
Study Start
September 30, 2023
Actual (reported)Primary Completion
August 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Study Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
September 30, 2023
Actual (reported)April 22, 2024
Actual (reported)April 25, 2024
Actual (reported)August 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Visual and standardized uptake values assessment of lesions and biodistribution
At least two experienced nuclear medicine physicians will conduct a visual analysis using consensus reading. The standardized uptake value (SUV) of tumor and organs will be measured after a semiquantitative analysis is conducted for each case. The SUV ranges from 0 to infinity, and a higher score means a higher uptake of targeting GPC3 nuclear probe by the tumor, which implies a greater threat of the tumor being malignant or higher stage.
1 year
Radioactivity in the blood and urine samples
1 year
Concentration of tumor markers (e.g., APF) in participants' blood
1 year
Pathological sections of tumour tissue
1 year
Determine if targeting GPC3 PET is safe and effective method for imaging of hepatocellular carcinoma
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.
Registry-reported names are shown in full. Names without a link have not yet been matched to a Syfrah profile.
China, Hubei Province
Wuhan, Hubei, 430022, China
Lin Z, Hu W, Li M, Pan Z, Feng Y, Zhang X, Yang B, Gai Y, Jiang D, Zhu J, Cai X, Lan X. Glypican-3-targeted immunoPET imaging of hepatocellular carcinoma: a translational study. Eur J Nucl Med Mol Imaging. 2026 May;53(6):3891-3903. doi: 10.1007/s00259-025-07739-5. Epub 2026 Feb 14.
Xiaoli Lan, PhD
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
First Submitted
April 22, 2024
First Posted
April 25, 2024
Study Start
September 30, 2023
Actual (reported)Primary Completion
August 31, 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Contact the study team to confirm eligibility.
Study Completion
December 2025
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Last Updated
May 14, 2025
Record last verified: 2024-12
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Source: ClinicalTrials.gov.
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