68Ga-NYM207 PET/CT Imaging in Hepatocellular Carcinoma

NCT07590336 | Not Yet Recruiting Phase 1

• 1 other identifier: K10590
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Hepatocellular Carcinoma (HCC)

Keywords

68Ga-NYM207; GPC3

Outcome Measures

Primary Outcomes (2)

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

  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)

  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 Outcomes (4)

• Dosimetry of 68Ga-NYM207

  From study completion to 1 month after completion

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

  From study completion to 1 month after completion

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

  From study completion to 1 month after completion

• Intensity of GPC3 staining of lesions with pathological results

  From study completion to 1 month after completion

Study Arms (1)

68Ga-NYM207 PET/CT

EXPERIMENTAL

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

Interventions

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.

68Ga-NYM207 PET/CT

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• ≥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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Peking Union Medical College Hospital: lead

Study Sites (1)

Peking Union Medical College Hospital

Beijing, 100730, China

Location

MeSH Terms

Conditions

Carcinoma, Hepatocellular

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Liver Neoplasms; Digestive System Neoplasms; Neoplasms by Site; Digestive System Diseases; Liver Diseases

Central Study Contacts

Li Huo

CONTACT

+86 18612672038; huoli@pumch.cn

Wenjia Zhu

CONTACT

+86 18614080164; zhuwenjia_pumc@163.com

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 15, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): June 1, 2027
• Last Updated: May 15, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Within 2 years after the publication of the main results

Locations

CN (1)