68Ga-NYM096 PET/CT in Various Kinds of Cancer

Официальное название

68Ga-NYM096 PET/CT: Tracer Uptake in Various Kinds of Cancer

Обзор

This is a prospective, single-center study aimed at evaluating the uptake characteristics of 68Ga-NYM096 PET/CT in various kinds of tumors including primary and metastatic lesions. Based on image analysis, this study will assess the uptake of various kinds of tumors using 68Ga-NYM096 PET/CT. The findings will provide critical insights into the tumor uptake on 68Ga-NYM096 PET/CT to identify the most promising indications for future application.

Подробное описание

This is a prospective, single-center study designed to evaluate the uptake characteristics of 68Ga-NYM096 PET/CT in various kinds of tumors including primary and metastatic lesions. Each patient will receive a single intravenous dose of 68Ga-NYM096, followed by dedicated whole-body PET/CT imaging. 68Ga-NYM096 PET/CT scans were requested by referring physicians according to individual clinical indications that were considered insufficiently covered by 18F-FDG PET/CT or other imaging modalities.

Quantitative analyses will be applied to assess the uptake of 68Ga-NYM096 in primary and metastatic lesions in different tumor types, including lesion number, SUVmax (40% isocontour), tumor-to-background ratio (TBR).

120 patients with histopathologically proven primary tumors or metastases or radiologically unequivocal metastatic lesions of histologically proven primary tumors 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

• Другое 68Ga-NYM096 PET/CT
  Participants will be administered a single, intravenous bolus of 68Ga-NYM096 The recommended administered activity of 68Ga-NYM096 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 68Ga / 68Ga generator. The CT and PET imaging session will begin approximately 45 to 75 minutes after 68Ga-NYM096 administration.

Первичные конечные точки

• Uptake characteristics (quantitative analysis) of tumor lesions including primary and metastatic lesions identified on 68Ga-NYM096 PET/CT [Срок оценки: From study completion to 1 month after completion]

Критерии участия

Критерии включения

• Age ≥ 18 y
• Histopathologically confirmed cancer (histopathologically proven primary tumors or metastases or radiologically unequivocal metastatic lesions of histologically proven primary tumors)
• Expected survival of at least 3 months
• ECOG ≤ 2
• Written informed consent provided for participation in the trial
• In the opinion of investigator, willing and able to comply with required study procedures.

Критерии исключения

• On VEGF TKI treatment less than 1 week before 68Ga-NYM096 PET/CT. TKI is known to affect girentuximab binding in patients with ccRCC and is expected to have the same effect on 68Ga-NYM096. If patients were on VEGF TKI treatment, such as sunitinib, sorafenib, cabozantinib, pazopanib, or lenvatinib, a washout of one week before 68Ga-NYM096 PET/CT is required.
• Intercurrent medical condition that renders the patient ineligible for the procedures.
• Pregnancy or breastfeeding.
• Severe claustrophobia.

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

Другое

Центры проведения

Китай · 1 центр

• Peking Union Medical College Hospital, Beijing, Beijing 100730 — Пекин

Идентификаторы

NCT: NCT07144748 · K8490

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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