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

Chinese Academy of Medical Sciences & Peking Union Medical College

Status and phase: Not yet enrolling; Phase 2; Phase 1

Conditions: Hepatocellular Carcinoma (HCC)

Treatments: Diagnostic Test: 68Ga-NYM207 PET/CT

Study type: Interventional

Funder types: Other

Identifiers

NCT07590336

K10590

Details and patient eligibility

About

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.

Full 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.

Enrollment: 100 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

100 participants in 1 patient group

68Ga-NYM207 PET/CT

Experimental group

Description:

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.

Treatment:

Diagnostic Test: 68Ga-NYM207 PET/CT