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Идёт набор NCT04559217

68Ga-DOTATATE Neuroblastoma Imaging Pilot

Фаза II С лечением Neuroblastoma

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: Radiopharmaceutical 68Ga-DOTATATE.
Кому может быть актуально
Состояния в реестре: Neuroblastoma. Базовые параметры: до 21 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
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →

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Официальное название

Pilot Study of 68Ga-DOTATATE PET/CT and 123I-MIBG Scintigraphy Imaging of Neuroblastoma

Обзор

Neuroblastoma is the most frequent extracranial childhood tumor, with an annual incidence of approximately 10.2 per million children. Staging of the disease can be done by different imaging strategies (CT, MRI, scintigraphy and PET/CT). Discrepancies may be observed among these different strategies resulting in different treatment strategies. The goal of this study is to assess the feasibility and safety of 68Ga-DOTATATE and to compare it to 123I-MIBG when investigating neuroblastoma.

Подробное описание

Background: Neuroblastoma is the most frequent extracranial childhood tumor, with an annual incidence of approximately 10.2 per million children. Initial staging of the disease and monitoring of the treatment response can be performed with different imaging modalities that include contrast-enhanced computed tomography (ceCT), ultrasound, magnetic resonance imaging (MRI), bone scintigraphy and 123I-MIBG scintigraphy.

Another potential target for neuroblastoma imaging is the somatostatin receptor (SSTR) that is present in many neuroendocrine tumours (NET). The superior PET imaging technology used with new radiotracers (such as 68Ga-DOTATATE) enables imaging at advantageous resolutions well below what is possible by current clinical SPECT systems that are used for 123I-MIBG.

Design: Prospective single-arm non-randomized clinical trial (phase II) - pilot

Objective: 1) Assess the feasibility and safety of 68Ga-DOTATATE PET/CT imaging in patients with neuroblastoma or suspected of having neuroblastoma. 2) Compare lesion-by-lesion the uptake of 68Ga-DOTATATE and 123I-MIBG in the same participant.

Study population: Children and adults with biopsy-proven or suspected neuroblastoma

Procedure and Follow-up: Few days after 123I-MIBG scan, participants will undergo a 68Ga-DOTA-cTATE PET/CT scan (duration 2 hours). Clinical data will be collected from this imaging and from the participant's medical record (demographic, treatment, medication, pathology, lab test results) for a 2-year follow-up period.

Вмешательства

  • Биопрепарат Radiopharmaceutical 68Ga-DOTATATE
    Injection of 68Ga-DOTATATE followed by PET/CT acquisition

Первичные конечные точки

  • Accrual rate [Срок оценки: For the duration of the study, lasting 6 years]
  • Rate of adverse events [Срок оценки: Up to 24 hours following injection of 68Ga-DOTATATE]
Вторичные конечные точки (2)
  • Positive lesions for 68Ga-DOTATATE [Срок оценки: One hour post-injection of 68Ga-DOTATATE]
  • Discordance of positive lesions for 68Ga-DOTATATE and positive lesions of 123I-MIBG [Срок оценки: Within one week (period between 123I-MIBG scan and 68Ga-DOTATATE scan)]

Критерии участия

Критерии включения

  • Newly suspected or biopsy-proven neuroblastoma or recurrence of neuroblastoma
  • Planned 123I-MIBG imaging
  • Able and willing to provide signed informed consent in French or English (for the adult candidates or the parent/legal tutor of the pediatric candidates)
  • Aged between 1 day and 21 years old (inclusively).

Критерии исключения

  • History of another cancer in the past 5 years other than non-melanomatous skin cancer.
  • Currently under a randomized control trial with unknown allocation;
  • Currently under treatment;
  • Medical/surgical intervention on the tumour between 123I-MIBG and 68Ga-DOTATATE PET/CT scan.
  • Medically unstable or unable to undergo scan.
  • Pregnancy (breastfeeding is not an exclusion criterion but needs to be stopped for at least 12 hours after 68Ga-DOTATATE injection).
  • Prior allergic reaction to somatostatin analogues

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

Канада · 3 центра
  • McGill University Health Center - Children's hospital — Montreal
  • CHU Ste-Justine — Montreal
  • CIUSSS de l'Estrie-CHUS Hospital — Sherbrooke

Идентификаторы

NCT: NCT04559217 · 2021-3828

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗