Evaluation of a Pneumotachograph (SPI) for the Production of PET and CT Acquisitions Synchronized With Breath for the Assessment of Extension of Lung Cancer (SPI COHERENCE)
This is a pilot study, single-center, prospective, open-label, to assess the acceptability and performance of the experimental medical device (SPI) used during an imaging examination (PET / CT 4D imaging in synchronized mode centered on the thorax). Each patient will be its own control, since the imaging examination will be synchronized simultaneously with the two systems: tested Medical Device (SPI) and reference Medical Device(RPM).
調査の概要
状態
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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-
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Toulouse、フランス、31052
- Institut Claudius REGAUD
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参加基準
適格基準
就学可能な年齢
健康ボランティアの受け入れ
受講資格のある性別
説明
Inclusion Criteria:
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Patient for whom there is an indication of PET/CT 18FDG imaging for thoracic oncology ; this indication is consistent with the Standard Options Recommendations or was validated during Multidisciplinary Consultation Meeting :
- Either an extension assessment of non-small cell lung cancer;
- Either the characterization of single pulmonary nodule; Or - the definition of the target volume in radiotherapy.
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Patient who meets the following criteria to be eligible for an PET/CT imaging:
- Patient able to maintain a supine position for 60 minutes
- Patient with no bronchopulmonary infection and with no upper aero digestive tract acute infection in progress (increased risk of false positives)
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Age ≥ 18 years
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WHO ≤ 1
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Well-informed written consent signed by the patient and collected before any specific procedure in the study
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Patient member in a national insurance scheme
Exclusion Criteria:
- Patient with a bronchial carcinoid or bronchoalveolar cancer
- Patient with acute bronchopneumopathy
- Not stabilized diabetic patient
- Patient with an absolute indication against spirometry: ongoing pneumothorax or within the previous month, pleural biopsy or puncture within the previous month, hemoptysis, severe asthma, tuberculosis
- Any usual relative indication against spirometry: ongoing bronchial infections, acute asthma, decompensation of chronic respiratory failure, respiratory pain
- Any usual formal indication against imaging examination PET/CT (important claustrophobia)
- Patient unable to follow study procedures
- Pregnant women or nursing mothers can not participate in the study
- Men and women of childbearing age must use effective contraception at study entry and throughout the study
- Any other medical conditions making the inclusion of the patient in the study inappropriate in the opinion of the investigator
- Patient under legal guardianship
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
- 主な目的：診断
- 割り当て：非ランダム化
- 介入モデル：単一グループの割り当て
- マスキング：なし（オープンラベル）
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
|
実験的：SPI Medical device
SPI medical device used during PET/CT 4D imaging in a synchronized mode centered on the thorax. |
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アクティブコンパレータ：reference medical device : RPM
Reference medical device (RPM) used simultaneously during PET/CT 4D imaging in a synchronized mode centered on the thorax. |
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 |
|---|---|---|
|
Feasibility of the PET/CT synchronized exam with SPI device ("success" or "failure" )
時間枠：2 years
|
feasibility is evaluated in a composite end point (success will be obtained in case of concomitant success of the 4 sub-criteria assessment):
|
2 years
|
二次結果の測定
結果測定 |
メジャーの説明 |
時間枠 |
|---|---|---|
|
Measure of dCycleRpm (dCycleRpmi = Number of synchronization signals emitted by RPM / total number of breath cycle * 100)
時間枠：2 years
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2 years
|
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Measure of BTVrpm (= biologic tumoral volume)
時間枠：2 years
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2 years
|
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Accuracy of detection of maximum inspiratory amplitudes with RPM medical device: evaluated by measuring dtRpm
時間枠：2 years
|
dtRpm = standard deviation of the time lag between synchronization signals and maximum inspiratory amplitude for each cycle |
2 years
|
協力者と研究者
スポンサー
捜査官
- 主任研究者：Frederic COURBON, PhD、Institut Claudius Regaud
出版物と役立つリンク
研究記録日
主要日程の研究
研究開始
一次修了 (実際)
研究の完了 (実際)
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 (推定)
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。