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NCT06383520RecruitingEarly phase 1

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

Source: ClinicalTrials.gov · Last updated 14 May 2025 · Not updated for over 12 months - ask the site whether it is still open

Brief summary (registry, in English)

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.

Status (registry)
Recruiting
Phase (registry)
Early phase 1
Study type
Interventional
Enrollment
100 (estimated)
First submitted
22 Apr 2024
Start date
30 Sept 2023
Primary completion date
31 Aug 2025
Lead sponsor
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
NCT number
NCT06383520

What you commit to

  • Study type: Interventional · Early phase 1
  • Planned participants: 100
  • From 30 Sept 2023 to the primary completion date, 31 Aug 2025
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • 6: Individuals who are unable to complete PET/MR or PET/CT examinations (including inability to lie flat, claustrophobia, radiation phobia, etc.)

Other illness

  • 3: Acute systemic diseases and electrolyte disorders
  • 4: Patients who are known to be allergic to GPC3 imaging agents or synthetic excipients

Lab values

  • 5: Fasting blood glucose levels exceeding 11.0 mmol/L before injection of 18F-FDG

Other

  • 1: Pregnant or lactating patients
  • 2: The patient or their legal representative is unable or unwilling to sign the informed consent form
  • 7: Researchers believe that compliance is poor or there are other unfavorable factors for participating in this experiment

Who the study is looking for

  • 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

Age in the registry: 18 years to 65 years · Sex: All · Accepts healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
China, Hubei Province
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WuhanChinaRecruiting

Related publications

This page is information, not medical advice. Discuss any trial with your doctor.