68Ga-NYM207 PET/CT Imaging in Hepatocellular Carcinoma

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Диагностический тест 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,

Первичные конечные точки

• Safety and tolerability after ⁶⁸Ga-NYM207 administration (Phase A) [Срок оценки: From study completion to 1 month after completion]
• Binary reading of focal lesions identified on 68Ga-NYM207 PET/CT (Phase B) [Срок оценки: From study completion to 1 month after completion]

Вторичные конечные точки (4)

• Dosimetry of 68Ga-NYM207 [Срок оценки: From study completion to 1 month after completion]
• SUVmax of focal lesions identified on 68Ga-NYM207 PET/CT [Срок оценки: From study completion to 1 month after completion]
• Tumor-to-background of focal lesions identified on 68Ga-NYM207 PET/CT [Срок оценки: From study completion to 1 month after completion]
• Intensity of GPC3 staining of lesions with pathological results [Срок оценки: From study completion to 1 month after completion]

Критерии участия

Критерии включения

• ≥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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Не применимо

Модель

Одна группа

Маскирование

Открытое

Основная цель

Диагностика

Центры проведения

Китай · 1 центр

• Peking Union Medical College Hospital — Пекин

Идентификаторы

NCT: NCT07590336 · K10590

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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