68Ga-NYM207 PET/CT Imaging in Hepatocellular Carcinoma (NYHCC)

May 14, 2026 updated by: Peking Union Medical College Hospital

Study on the Clinical Application of GPC3-targeting 68Ga-NYM207 PET/CT 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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

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.

Study Type

Interventional

Enrollment (Estimated)

100

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
      • Beijing, China, 100730
        • Peking Union Medical College Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68Ga-NYM207 PET/CT
68Ga-NYM207 PET/CT Each patient will receive one dose of 68Ga-NYM207 by intravenous route. Dedicated whole-body PET/CT imaging will be performed.
Diagnostic test: 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From study completion to 1 month after completion
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.
From study completion to 1 month after completion

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
From study completion to 1 month after completion
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.
From study completion to 1 month after completion
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.
From study completion to 1 month after completion
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
From study completion to 1 month after completion

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Peking Union Medical College Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

June 1, 2026

Primary Completion (Estimated)

June 1, 2027

Study Completion (Estimated)

June 1, 2027

Study Registration Dates

First Submitted

May 6, 2026

First Submitted That Met QC Criteria

May 14, 2026

First Posted (Actual)

May 15, 2026

Study Record Updates

Last Update Posted (Actual)

May 15, 2026

Last Update Submitted That Met QC Criteria

May 14, 2026

Last Verified

April 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • K10590

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Available upon request

IPD Sharing Time Frame

Within 2 years after the publication of the main results

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Hepatocellular Carcinoma (HCC)

Clinical Trials on 68Ga-NYM207 PET/CT

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Cameroon

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe