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Набор по приглашению NCT07101900

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

Фаза II С лечением Clear Cell Renal Cell Carcinoma

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: Clear Cell Renal Cell Carcinoma. 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

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

Обзор

This is a prospective, single-center, single-arm, diagnostic phase 2 study in patients who have renal masses scheduled for surgical resection. The goal is to determine the sensitivity and specificity of 68Ga-NYM096 PET/CT in the detection of clear cell renal cell carcinoma using histopathological diagnosis as ground truth, in patients with operable renal masses.

Подробное описание

This is a prospective, single-center, single-arm, diagnostic phase 2 study in patients with renal masses scheduled for surgical resection. Each patient will receive one dose of 68Ga-NYM096 by intravenous route. Dedicated whole-body PET/CT imaging will be performed. Additionally, prior to resection of the tumor, contrast-enhanced CT imaging of the abdomen, and if clinically warranted, or as part of the local standard of care, of the chest, will be performed. Both imaging modalities will be performed prior to resection of the kidney(s). PET/CT studies will be interpreted by two readers and diagnostic CT will be interpreted by one reader, all of whom will provide independent and blinded interpretations. Imaging interpretations and histopathologic evaluation data will be used to estimate the sensitivity, specificity, and predictive value (primary and secondary objectives) of each modality. The exploration into the detection of metastases by 68Ga-NYM096 PET/CT in comparison to diagnostic CT will also be performed.

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

100 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

  • Histological classification of operated renal lesions [Срок оценки: From study completion to 1 month after completion]
  • Binary reading of renal lesions identified on 68Ga-NYM096 PET/CT [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-NYM096 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]
  • 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]
  • 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]
  • Location of metastatic lesions on diagnostic CT [Срок оценки: From study completion to 1 month after completion]
  • Size of metastatic lesions on diagnostic CT [Срок оценки: From study completion to 1 month after completion]

Критерии участия

Критерии включения

  • Age: ≥18 years;
  • Gender: No restriction;
  • Renal mass (solitary or multiple) with a maximum diameter ≥1 cm, confirmed by conventional imaging (ultrasound, non-contrast CT, contrast-enhanced CT, or MRI);
  • Scheduled for renal mass resection (partial or total nephrectomy, via open, laparoscopic, or robot-assisted techniques) within 1 month;
  • Life Expectancy:
  • At least 3 months, as assessed by a clinician;
  • ECOG Performance Status: 0-2;
  • Informed Consent: Provision of written informed consent;
  • Compliance: Willing and able to adhere to study procedures.

Критерии исключения

  • Surgical Contraindications:
  • High anesthesia risk (ASA class ≥IV);
  • Severe cardiopulmonary dysfunction (NYHA class III-IV or FEV1 <50%);
  • Active bleeding or coagulation disorders (INR >1.5, platelets <80×10⁹/L).
  • Pregnancy/Lactation:
  • Pregnant (positive blood/urine HCG) or breastfeeding women;
  • childbearing potential without effective contraception.
  • Other Contraindications:
  • Claustrophobia;
  • Weight >150 kg ;
  • Alcohol allergy.
  • 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: NCT07101900 · K8607

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗