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Идёт набор NCT06949215

68Ga-NYM096 PET/ CT for the Detection of ccRCC in Presurgical Patients With Complex Cystic Renal Leision

Фаза II С лечением ccRCC Complex Renal Cyst

Ориентир для пациента и семьи

Простыми словами

Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.

Что изучают
В протоколе указаны: 68Ga-NYM096 PET/CT.
Кому может быть актуально
Состояния в реестре: ccRCC, Complex Renal Cyst. Базовые параметры: от 18 лет · Все.
Что важно проверить
Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
Где проводится
Китай
Следующий шаг
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Официальное название

68Ga-NYM096 PET/ CT for the Detection of Clear Cell Renal Cell Carcinoma in Presurgical Patients With Complex Cystic Renal Leision

Обзор

This is a prospective, single-center, single-arm, diagnostic phase 2 study aimed at evaluating the sensitivity and specificity of 68Ga-NYM096 PET/CT in detecting clear cell renal cell carcinoma (ccRCC) in patients with complex renal cysts who are scheduled for surgical resection. The study will use histopathological diagnosis as the reference standard to assess the diagnostic accuracy of 68Ga-NYM096 PET/CT in identifying ccRCC within operable complex renal cystic lesion. The findings will provide critical insights into the performance of 68Ga-NYM096 PET/CT as a non-invasive imaging tool for the preoperative detection of ccRCC in this patient population.

Подробное описание

This is a prospective, single-center, single-arm, diagnostic phase 2 study designed to evaluate the efficacy of 68Ga-NYM096 PET/CT in detecting clear cell renal carcinoma (ccRCC) in patients with complex renal cysts who are scheduled for surgical resection. Each patient will receive a single intravenous dose of 68Ga-NYM096, followed by dedicated whole-body PET/CT imaging. Prior to tumor resection, contrast-enhanced CT imaging of the abdomen will be conducted, and if clinically indicated or as part of the local standard of care, imaging of the chest will also be performed. Both imaging modalities (68Ga-NYM096 PET/CT and diagnostic CT) will be completed before kidney resection.

The PET/CT images will be independently interpreted by two blinded readers, while the diagnostic CT images will be evaluated by one blinded reader. The interpretations from both imaging modalities will be compared with histopathologic findings to estimate sensitivity, specificity, and predictive values (primary and secondary objectives). Additionally, the study will explore the performance of 68Ga-NYM096 PET/CT in detecting metastases compared to diagnostic CT. This study aims to provide insights into the diagnostic accuracy of 68Ga-NYM096 PET/CT for identifying ccRCC in patients with complex renal cysts.

The pathologist will identify representative tumor tissue for the determination of histology, grading, and CAIX expression.

39 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-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

  • Binary reading of renal lesions identified on 68Ga-NYM096 PET/CT [Срок оценки: From study completion to 1 month after completion]
  • Histological classification of operated renal lesions [Срок оценки: From study completion to 1 month after completion]
Вторичные конечные точки (12)
  • SUVmax of renal lesions identified on 68Ga-NYM096 PET/CT [Срок оценки: From study completion to 1 month after completion]
  • Intensity of CAIX staining of operated renal lesions [Срок оценки: From study completion to 1 month after completion]
  • SUVmax of liver uptake on 68Ga-NY104 PET/CT [Срок оценки: From study completion to 1 month after completion]
  • Tumor grade of operated renal lesions [Срок оценки: From study completion to 1 month after completion]
  • Extent of CAIX staining of operated renal lesions [Срок оценки: From study completion to 1 month after completion]
  • Binary reading of renal lesions identified on diagnostic CT [Срок оценки: From study completion to 1 month after completion]
  • Size of renal lesions identified on diagnostic CT [Срок оценки: From study completion to 1 month after completion]
  • Bosniak category of lesion on diagnostic CT [Срок оценки: From study completion to 1 month after completion]
  • Number of metastatic lesions identified on 68Ga-NYM096 PET/CT [Срок оценки: From study completion to 1 month after completion]
  • Location of metastatic lesions identified on 68Ga-NYM096 PET/CT [Срок оценки: From study completion to 1 month after completion]
  • Size of metastatic lesions identified on 68Ga-NYM096 PET/CT [Срок оценки: From study completion to 1 month after completion]
  • Number of metastatic lesions identified on diagnostic CT [Срок оценки: From study completion to 1 month after completion]

Критерии участия

Критерии включения

  • Age ≥ 18 y
  • Presence of complex renal cyst (Bosniak category II or higher)
  • Scheduled for surgical resection of renal mass (partial or total nephrectomy, open, laparoscopic, or robot-assisted technique)
  • 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 surgery.
  • 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
Диагностика

Центры проведения

Китай · 1 центр
  • Peking Union Medical College — Пекин

Идентификаторы

NCT: NCT06949215 · NYCRCCL

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗