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Набор скоро начнётся NCT07621146

A Comparison of [68Ga]DOTATATE and [18F]AmBF3TATE for the Staging and Assessment of Neuroendocrine Malignancies

— Наблюдательное Neuroendocrine Tumors, NET Pheochromocytoma/Paraganglioma SSTR-expressing Tumors Medullary Thyroid 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-DOTATATE PET/CT, 18F-AmBF3-TATE PET/CT.
Кому может быть актуально
Состояния в реестре: Neuroendocrine Tumors, NET, Pheochromocytoma/Paraganglioma, SSTR-expressing Tumors, Medullary Thyroid 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
Канада
Следующий шаг
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Официальное название

A Prospective and Head-to-head Comparison of [68Ga] Ga-DOTATATE and [18F]AmBF3TATE for the Staging and Assessment of Neuroendocrine Malignancies: NET-COMPARE Study

Обзор

Neuroendocrine tumours (NETs) are generally slow growing, but some can be aggressive and resistant to treatment. Compared to healthy cells, the surface of these tumor cells has a greater number of molecules called somatostatin receptors (SSTR) which requires specific PET scan tracers to sufficiently capture on images. The current standard of care tracer at BC Cancer for SSTRs on NETs is 68Ga-DOTATATE. This project seeks to identify if 18F-AmBF3-TATE (a tracer that has established safety from phase 1 trial results), is comparable in disease detection, no. of lesions identified, image quality, safety and overall accuracy, to 68Ga-DOTATATE.

Вмешательства

  • Диагностический тест 68Ga-DOTATATE PET/CT
    Each study participant will have an intravenous catheter inserted. The participant will receive a bolus intravenous dose of the standard of care tracer 68Ga-DOTATATE from an approved study supplier site. The participant will rest in a comfortable chair for 60 minutes. After this uptake phase, the participant will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract. Participants are positioned supin
  • Диагностический тест 18F-AmBF3-TATE PET/CT
    Each study participant will have an intravenous catheter inserted. The participant will receive a bolus intravenous dose of the investigational tracer 18F-AmBF3-TATE from an approved study supplier site. The participant will rest in a comfortable chair for 60 minutes. After this uptake phase, the participant will then be taken to a designated washroom and asked to void prior to being scanned in order to clear excreted radiotracer activity from the urinary tract. Participants are positioned supin

Первичные конечные точки

  • Number of lesions detected by [18F]AmBF3TATE compared to [68Ga]DOTATATE [Срок оценки: Periprocedural]
Вторичные конечные точки (5)
  • Number of patients in whom one or more target lesions are detected by the core readers. [Срок оценки: within 2 weeks of the scan]
  • Standard Uptake Values (SUV) for lesions detected [Срок оценки: within 2 weeks of the scan]
  • CNR (contrast to noise ratio), TBR (tumor tissue to background tissue ratio), Tumor/blood; Tumor/Liver; Tumor/ kidney; tumor/lung, Likert scale for reader quality assessment [Срок оценки: within 2 weeks of the scan]
  • Diagnostic confidence on a three-point scale (high, moderate and low), Fleiss' Kappa to measure inter-rater agreement [Срок оценки: within 2 weeks of the scan]
  • Frequency of adverse events (AE) and serious adverse events (SAE). [Срок оценки: Immediately post-scan]

Критерии участия

Критерии включения

  • Age ≥18 years
  • Patients referred for and meeting institutional criteria for a \[68Ga\]DOTATATE PET/CT for the investigation of a known or suspected neuroendocrine malignancy (BC Cancer criteria APPENDIX A).

Критерии исключения

  • Pregnant and breast-feeding patients.
  • Patients unwilling or unable to undergo a second PET/CT.
  • Patients exceeding the safe weight limit of the scanner (204.5 kg) or who cannot fit through the PET/CT bore (70cm diameter).

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Когортное

Центры проведения

Канада · 1 центр
  • BC Cancer Vancouver — Vancouver

Идентификаторы

NCT: NCT07621146 · H26-00640

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗