Skip to main content
OpenTrials
Not Yet Recruiting

NCT Number: NCT07590336

68Ga-NYM207 PET/CT Imaging in Hepatocellular Carcinoma

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.

Not Yet Recruiting

Trial opening soon.

Get Notified

Key information

Conditions

Hepatocellular Carcinoma (HCC) Adenocarcinoma Carcinoma Carcinoma, Hepatocellular Digestive System Diseases Digestive System Neoplasms Liver Diseases Liver Neoplasms Neoplasms Neoplasms by Histologic Type Neoplasms by Site Neoplasms, Glandular and Epithelial

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Peking Union Medical College Hospital

Beijing, 100730, China

About this study

Each patient will receive a single intravenous dose of 68Ga-NYM096, followed by dedicated whole-body PET/CT imaging. Safety, tolerability and imaging characteristics of ⁶⁸Ga-NYM207 will be evaluated. Imaging interpretations and reference standards will be used to estimate the sensitivity and specificity of 68Ga-NYM207 PET/CT.

Patients will be recruited in Peking Union Medical College Hospital. This study will be conducted according to local regulations and laws, the ethical principles that have their origin in the Declaration of Helsinki, and the principles of Good Clinical Practice.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • ≥18 years of age and of either gender;
  • Written informed consent provided for participation in the trial;
  • At least one of the following indications should be applied:
  • scheduled for surgical resection or biopsy of the liver mass within one month;
  • 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);
  • Willing and able to follow schedule visits, treatment plans and laboratory tests.

Exclusion criteria

  • Pregnancy or lactation;
  • Severe claustrophobia;
  • On treatment with anti-tumor drugs targeting GPC3;
  • Any condition deemed by the investigator to interfere with study results or increase participant risk.

Treatment and study plan

68Ga-NYM207 PET/CT

Diagnostic Test

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.

Primary outcomes

  1. Safety and tolerability after ⁶⁸Ga-NYM207 administration (Phase A)

    Time frame: From study completion to 1 month after completion

    Number of adverse events associated with administration of ⁶⁸Ga-NYM207 will be recorded.

  2. Binary reading of focal lesions identified on 68Ga-NYM207 PET/CT (Phase B)

    Time frame: 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.

Secondary outcomes

  1. Dosimetry of 68Ga-NYM207

    Time frame: From study completion to 1 month after completion

    OLINDA/EXM will be used to determine the absorbed dose and effective dose per patient.

  2. SUVmax of focal lesions identified on 68Ga-NYM207 PET/CT

    Time frame: From study completion to 1 month after completion

    Tracer uptake is quantified using maximal standard uptake value (SUVmax) by drawing a 3-dimensional region of interest (ROI) over the lesion using a threshold of 40% SUVmax.

  3. Tumor-to-background of focal lesions identified on 68Ga-NYM207 PET/CT

    Time frame: From study completion to 1 month after completion

    Surrounding tissue is the preferred background tissue. Should not available, the blood pool should be designated as background tissue.

  4. Intensity of GPC3 staining of lesions with pathological results

    Time frame: From study completion to 1 month after completion

    The intensity of CAIX staining of operated renal lesions will be based on a 4-point scale from 0-3 according to the method of Bui et al, 2003

Study contacts

Contact information is provided by the study sponsor or research team.

Li Huo

CONTACT

[email protected]

+86 18612672038

Wenjia Zhu

CONTACT

[email protected]

+86 18614080164

Sponsors and collaborators

Lead sponsor

Peking Union Medical College Hospital

Other

Registry information

Official study title

Study on the Clinical Application of GPC3-targeting 68Ga-NYM207 PET/CT in Hepatocellular Carcinoma

Acronym: NYHCC

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
May 15, 2026
Registry last updated
May 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.