18FDG-PET Imaging to Detect Changes in Airways Inflammation in Cystic Fibrosis Patients
A Pilot Study of 18FDG-PET Imaging to Detect Changes in Airways Inflammation in Cystic Fibrosis Patients After Treatment for a Pulmonary Exacerbation
調査の概要
詳細な説明
Neutrophils play a key role in the pathogenesis of CF lung disease. We know that neutrophilic inflammation is related to a decline in pulmonary function. Therefore, early anti-inflammatory intervention is an opportunity to slow this irreversible pulmonary destruction. However, the development of sensitive, non-invasive diagnostic tools of airways inflammation is essential to the study and implementation of anti-inflammatory therapies. Our current armentarium of measures of airways inflammation is limited. BAL is invasive and not clinically acceptable as a tool for the serial measurement of inflammation. Sputum samples are highly variable and not reliable.
18FDG-PET is a promising tool because it is non invasive, has been shown to quantify the amount and location of neutrophilic inflammation and has the potential to be used to track inflammation over time. Therefore, the goal of this research study is to evaluate the ability of 18FDG -PET imaging to detect changes in airways inflammation in CF patients in response to conventional treatment for a pulmonary exacerbation
研究の種類
入学 (実際)
段階
- フェーズ 3
連絡先と場所
研究場所
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Ontario
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Toronto、Ontario、カナダ
- The Hospital for Sick Children
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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:
- Diagnosis of CF as defined by two or more clinical features of CF and a documented sweat chloride > 60mEq/L by quantitative pilocarpine iontophoresis test or a genotype showing two well characterized disease causing mutations
- Informed consent and verbal assent (as appropriate) provided by the subject's parent or legal guardian and the subject
- Ages 6-18 and able to perform reproducible spirometry
- Admission to the Hospital for Sick Children for a pulmonary exacerbation
Exclusion Criteria:
- Inability to perform reproducible spirometry
- Diagnosis of Cystic Fibrosis Related Diabetes (CFRD)
- Medical instability that would preclude the ability to perform PET imaging
- FEV1% predicted < 40%
- The use of supplementary oxygen
- Pregnancy or breastfeeding
- Severe claustrophobia
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:なし
- 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 |
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実験的:1
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The administered intravenous dose of 18-FDG is 0.14mCi/kg up to a maximum of 10mCi before each PET imaging scan is performed.
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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 |
時間枠 |
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Change in airways inflammation detected by 18FDG -PET from baseline
時間枠:Measured at end of treatment (day 14)
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Measured at end of treatment (day 14)
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二次結果の測定
結果測定 |
時間枠 |
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Correlation of pre and post 18FDG-PET data with lung function (FEV1, FEF 25-75 and FVC), sputum neutrophil count and sputum free elastase
時間枠:Measured at end of treatment (day 14)
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Measured at end of treatment (day 14)
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協力者と研究者
捜査官
- 主任研究者:Felix Ratjen, MD、The Hospital for Sick Children
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 (見積もり)
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。
18-FDGの臨床試験
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University of California, Los AngelesCenters for Medicare and Medicaid Services完了
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University of SaskatchewanSaskatoon Health Region; Sylvia Fedoruk Canadian Centre for Nuclear Innovation完了陽電子放出断層撮影とコーンビームCT
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University Health Network, TorontoSunnybrook Health Sciences Centre募集
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Mayo ClinicNational Institute on Aging (NIA)招待による登録
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National Cancer Institute (NCI)完了IV期乳がん | 再発乳癌 | エストロゲン受容体陽性乳がん | プロゲステロン受容体陰性乳がん | プロゲステロン受容体陽性乳がんアメリカ