68Ga-NYM207 PET/CT imaging to detect liver cancer

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This is a prospective, single-center, single-arm, phase I/II study evaluating safety, tolerability, and imaging features of 68Ga-NYM207. Phase A will assess safety and imaging characteristics, while Phase B will measure diagnostic performance for detecting HCC. Participants receive one IV dose of 68Ga-NYM207 followed by whole-body PET/CT, with imaging results compared to reference standards to estimate sensitivity and specificity. The trial is conducted at Peking Union Medical College Hospital in accordance with ethical and regulatory requirements. Eligible participants include adults with suspected liver tumors or a history of HCC requiring biopsy or resection, while major exclusions include pregnancy, claustrophobia, and anti-tumor GPC3 therapies.

Why it matters

Who can join: the full rules

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 suspected of HCC within one month;
   2. with a history of HCC, recurrence or metastasis during follow-up (based on laboratory 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.

Where it's running

• Peking Union Medical College Hospital
  Beijing, China Recruiting

Study contacts

• Study coordinator: Li Huo
• Email: huoli@pumch.cn
• Phone: +86 18612672038

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.