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Not yet recruiting NCT07590336

68Ga-NYM207 PET/CT Imaging in Hepatocellular Carcinoma

Phase I / Phase II Interventional Hepatocellular Carcinoma (HCC)

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: 68Ga-NYM207 PET/CT.
Who it may be relevant to
Registry conditions: Hepatocellular Carcinoma (HCC). Basic parameters: from 18 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
China
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

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

Overview

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.

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.

Interventions

  • 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,

Primary outcome measures

  • Safety and tolerability after ⁶⁸Ga-NYM207 administration (Phase A) [Time frame: 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]
Secondary outcome measures (4)
  • Dosimetry of 68Ga-NYM207 [Time frame: 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]
  • Tumor-to-background of focal lesions identified on 68Ga-NYM207 PET/CT [Time frame: 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]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
N/A
Model
Single group
Masking
Open label
Primary purpose
Diagnostic

Study locations

China · 1 center
  • Peking Union Medical College Hospital — Beijing

Identifiers

NCT: NCT07590336 · K10590

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗