Early [18F]-FDG PET Dynamic Analysis in Brain Metastases After Radiotherapy. (DYNFDGTEP)
Interest of Early Dynamic Analysis of [18F]-FDG PET Images in the Differential Diagnosis Between Recurrence and Radionecrosis in Brain Metastases.
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.
調査の概要
研究の種類
入学 (推定)
連絡先と場所
研究連絡先
- 名前：Antoine GIRARD
- 電話番号：33+3 22 45 03 81
- メール：Girard.Antoine@chu-amiens.fr
研究場所
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Amiens、フランス
- 募集
- CHRU Amiens
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副調査官：
- Alexandre COUTTE, MD
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副調査官：
- Mathieu BOONE, MD
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コンタクト：
- Antoine GIRARD, MD
- 電話番号：33+3 22 45 03 81
- メール：Girard.Antoine@chu-amiens.fr
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副調査官：
- Ismaël NEJJAR, MD
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副調査官：
- Marc-Etienne MEYER, Pr
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副調査官：
- Chalabia FERGANI, MD
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副調査官：
- Florent Hives, MD
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参加基準
適格基準
就学可能な年齢
- 大人
- 高齢者
健康ボランティアの受け入れ
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
研究計画
研究はどのように設計されていますか？
デザインの詳細
この研究は何を測定していますか？
主要な結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
ratio between lesion maximum activity and controlateral healthy tissue activity
時間枠：day1
|
Value of the measurement of the ratio of the maximum activity within the lesion to the average activity within the region of interest of the contralateral healthy tissue.
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day1
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二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
association between kinetic uptake parameters and diagnosis
時間枠：12 months
|
association between kinetic uptake parameters from compartmental models and the differential diagnosis of radionecrosis and recurrence of brain metastases treated by radiotherapy
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12 months
|
協力者と研究者
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (推定)
研究の完了 (推定)
試験登録日
最初に提出
QC基準を満たした最初の提出物
最初の投稿 (実際)
学習記録の更新
投稿された最後の更新 (実際)
QC基準を満たした最後の更新が送信されました
最終確認日
詳しくは
この情報は、Web サイト clinicaltrials.gov から変更なしで直接取得したものです。研究の詳細を変更、削除、または更新するリクエストがある場合は、register@clinicaltrials.gov。 までご連絡ください。 clinicaltrials.gov に変更が加えられるとすぐに、ウェブサイトでも自動的に更新されます。