68Ga-NYM207 PET/CT: Participants will be administered a single, intravenous bolus of 68Ga-NYM207. The recommended administered activity of 68Ga-NYM207 is 1.8-2.2 MBq per kilogram bodyweight, subject to variation that may be required owing to variable elution efficiencies obtained during the lifetime of the 68Ge/68Ga generator. For biodistribution and imaging characteristics evaluation, PET scans will be performed at 15min, 30min, 60min, and 120min after 68Ga-NYM207 administration. For diagnostic performance study, the CT and PET imaging session will begin approximately 45 to 75 minutes after 68Ga-NYM207 administration.
Study summary
This is a prospective, single-center, single-arm, phase I/II study designed to evaluate (1) the safety, tolerability, and imaging characteristics of 68Ga-NYM207 (Phase A), and (2) the diagnostic performance of 68Ga-NYM207 in detecting hepatocellular carcinoma (HCC) (Phase B). This study will provide critical insights into the performance of 68Ga-NYM207 PET/CT as a non-invasive imaging tool for the detection of HCC.
Eligibility
Sex
ALL
Min age
18 Years
Max age
—
Healthy volunteers
No
Inclusion Criteria:
1. ≥18 years of age and of either gender;
2. Written informed consent provided for participation in the trial;
3. At least one of the following indications should be applied:
1. scheduled for surgical resection or biopsy of the liver mass within one month;
2. with a history of HCC, recurrence or metastasis during follow-up (based on histopathologic examination or typical appearance of imaging data including conventional imaging or 18F-FDG PET/CT scan);
4. Willing and able to follow schedule visits, treatment plans and laboratory tests.
Exclusion Criteria:
1. Pregnancy or lactation;
2. Severe claustrophobia;
3. On treatment with anti-tumor drugs targeting GPC3;
4. Any condition deemed by the investigator to interfere with study results or increase participant risk.
Primary outcome measure(s)
Safety and tolerability after ⁶⁸Ga-NYM207 administration (Phase A) — From study completion to 1 month after completion Number of adverse events associated with administration of ⁶⁸Ga-NYM207 will be recorded.
Binary reading of focal lesions identified on 68Ga-NYM207 PET/CT (Phase B) — From study completion to 1 month after completion Any focal accumulation in the lesion suspected of metastasis or recurrence that cannot be explained by physiologic uptake of68Ga-NYM207 will be interpreted as PET positive.
Trial sites (1)
Facility
City
Region
Status
Peking Union Medical College Hospital
Beijing
China
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This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
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