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New treatment option for Malignant Neoplasm of Liver
Official title Study on the Clinical Application Value of PET Imaging Targeting GPC3 in Hepatocellular Carcinoma
ClinicalTrials.gov ID: NCT06383520
What this study is testing
What is 68Ga-aGPC3-scFv/Fab?
68Ga-aGPC3-scFv/Fab is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for malignant neoplasm of liver.
Also referred to as gallium-68(68Ga)-aGPC3-scFv/Fab.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 65. Healthy volunteers may be eligible.
You may be able to join if
- 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...
- 4: Healthy volunteer
- 5: Patients with a history of hepatocellular carcinoma, remission and recurrence after treatment
You likely can't join if
- 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.)
See the full eligibility 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...
- 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
- 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
The study team makes the final eligibility decision.
Where it's taking place
- Wuhan, Hubei, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 65 years. Healthy volunteers may be eligible. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Wuhan, Hubei, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.