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Идёт набор NCT07632092

Early [18F]-FDG PET Dynamic Analysis in Brain Metastases After Radiotherapy.

Наблюдательное Short Time Examination Brain Metastases Radiation Necrosis

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: CT scan.
Кому может быть актуально
Состояния в реестре: Short Time Examination, Brain Metastases, Radiation Necrosis. 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
Франция
Следующий шаг
Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
Официальное название

Interest of Early Dynamic Analysis of [18F]-FDG PET Images in the Differential Diagnosis Between Recurrence and Radionecrosis in Brain Metastases.

Обзор

Various treatment options are available for brain metastases, depending on factors such as lesion site or number lesions. Radiotherapy is a commonly used treatment. Following stereotactic radiotherapy for brain metastases, a potential complication, namely brain radionecrosis, can occur subsequently. It is essential to differentiate between this radionecrosis and lesion recurrence in order to determine the appropriate treatment approach. Contrast-enhanced magnetic resonance imaging (MRI) is the most widely used technique for monitoring brain metastases. Therefore, patients undergo routine MRI at 3 months and during subsequent follow-ups, but if the lesion evolve and if distinguishing between recurrence and radionecrosis is challenging, an \[18F\]-FDG PET scan is then prescribed by oncologists or radiotherapists during follow-up consultations. As part of the standard patient management protocol, a 10-minute image acquisition begins after a 45-60 minutes wait following the radiotracer injection. A second image acquisition is then conducted 3-4 hours later. For both acquisitions, a low-dose X-ray scanner is synchronously coupled to allow attenuation correction of the PET images. Patient for whom a \[18F\]-FDG PET cerebral examination has been prescribed as part of the usual management of brain metastases will be eligible to the protocol. If the patient agrees to participate, an early imaging session is initiated immediately upon radiotracer injection, lasting 15 minutes in addition to the standard acquisition protocol.

Вмешательства

  • Другое CT scan
    The patient is installed in the PET camera as soon as he is injected, so that early fixation of the \[18F\]-FDG radiotracer can be recorded for 15 minutes. As part of this acquisition, a CT scan dedicated for attenuation correction is also performed. Both this scan and the late scan will be carried out at ultra--low dose so that the total dose received by the patient does not exceed what he would have received without this research. The patient's total examination time remains unchanged

Первичные конечные точки

  • ratio between lesion maximum activity and controlateral healthy tissue activity [Срок оценки: day1]
Вторичные конечные точки (1)
  • association between kinetic uptake parameters and diagnosis [Срок оценки: 12 months]

Критерии участия

Критерии включения

  • Patient referred for cerebral \[18F\]-FDG PET examination prescribed as part of his usual medical care for brain metastasis.
  • Age ≥ 18 years old
  • Affiliation to a social security program
  • Ability of the subject to understand and express his consent

Критерии исключения

  • Age under 18 years old
  • Person under guardianship or curatorship
  • Pregnant or breastfeeding woman
  • Primary brain tumors
  • Brain metastases from renal, thyroid or other cancers known to have low avidity for \[18F\]-FDG

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

Здоровые добровольцы: Нет

Дизайн исследования

Модель наблюдения
Только случаи

Центры проведения

Франция · 1 центр
  • CHRU Amiens — Amiens

Идентификаторы

NCT: NCT07632092 · PI2026_843_0020

Первоисточники (государственные реестры)

Открыть это исследование на ClinicalTrials.gov ↗