PET/MR Imaging In Patients With Cardiac Sarcoidosis
Molecular Imaging in Cardiovascular Disease Using Hybrid Positron Emission Tomography/Magnetic Resonance Imaging (PET/MR): Cardiac Sarcoidosis
PET scanning (positron emission tomography) is a well-established technique used to identify areas of interest within the body. It involves injecting a radioactive tracer which highlights abnormal areas. It has recently been combined with CT (computed tomography) and MRI (magnetic resonance imaging) scanning to more accurately identify abnormalities within the heart. Cardiac sarcoidosis, a condition which causes scarring and inflammation within the heart muscle, is of particular interest.
The study makes use of hybrid PET/MR scanning using a designated scanner which enables PET scanning combined with MRI scanning. This will allow imaging of abnormal areas within the heart in this condition alongside treatment regimens in a way which hasn't been done before. If successful, this imaging method will play a key role in diagnosing, quantifying and monitoring these conditions.
All participants will undergo PET scanning, where a radioactive tracer is injected into a vein before the scan. The radioactive substance only lasts for a short time and is safe, passed out of the body in urine. The scan will be performed twice; once before treatment and once after treatment has been established. A cohort of healthy volunteers will undergo scanning in exactly the same way to enable us to compare the results with hearts of people who don't have cardiac sarcoidosis.
調査の概要
研究の種類
入学 (予想される)
段階
- 適用できない
連絡先と場所
研究場所
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Midlothian
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Edinburgh、Midlothian、イギリス、EH16 4TJ
- 募集
- Queen's Medical Research Institute
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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:
Cardiac Sarcoidosis Patients:
- Aged over 40 years
- Completion of informed consent
- Established diagnosis of cardiac sarcoidosis
- Established diagnosis as per HRS recommended diagnostic criteria
Healthy Volunteers:
- Aged over 40
- Completion of informed consent
Exclusion Criteria:
- All participants:
- Inability or unwilling to give informed consent
- Women who are pregnant, breastfeeding or of child-bearing potential (women who have experienced menarche, are pre-menopausal and have not been sterilised) will not be enrolled into the trial.
- Major intercurrent illness with life-expectancy <2 years.
- Renal dysfunction (eGFR less than or equal to 30ml/min/1.73m2)
- Adverse reaction or hypersensitivity to 18F-FDG PET tracer
- NYHA Class IV heart failure
- Patients with atrial fibrillation and poor rate control
- Contraindications to MRI scanning
- Previous history of contrast allergy of adverse reactions (Gadolinium-containing agents)
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:並列代入
- 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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他の:Cardiac Sarcoidosis
Patients with an established diagnosis of cardiac sarcoidosis.
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Hybrid 18F-FDG PET/MR imaging for observational diagnostic purposes.
Oral course of Prednisolone for treatment of sarcoidosis (patient cohort) or as control (healthy volunteer cohort)
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他の:Healthy volunteers
Healthy volunteer subjects of similar age and gender to patient cohort.
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Hybrid 18F-FDG PET/MR imaging for observational diagnostic purposes.
Oral course of Prednisolone for treatment of sarcoidosis (patient cohort) or as control (healthy volunteer cohort)
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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 |
メジャーの説明 |
時間枠 |
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Myocardial 18F-FDG uptake
時間枠:Within 1 year
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Quantification of myocardial PET tracer uptake before steroid therapy
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Within 1 year
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Myocardial 18F-FDG uptake
時間枠:Within 1 year
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Quantification of myocardial PET tracer uptake after steroid therapy
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Within 1 year
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協力者と研究者
スポンサー
研究記録日
主要日程の研究
研究開始 (実際)
一次修了 (予想される)
研究の完了 (予想される)
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。
18F-FDGの臨床試験
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Affiliated Hospital of Jiangnan University募集
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Tim LauMcGill Universityまだ募集していません認識機能障害 | 認知症 | レビー小体型認知症
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Andrei IagaruNational Cancer Institute (NCI)完了ステージ IIIA 非小細胞肺がん | ステージ IIIB 非小細胞肺がん | 転移性腎細胞がん | III期の腎細胞がん | IV期の非小細胞肺がん | IV期乳がん | B細胞腫瘍 | IIIA期乳がん | IV期の腎細胞がん | IIIC期の乳がん | エストロゲン受容体陰性 | HER2/Neu陰性 | プロゲステロン受容体陰性 | トリプルネガティブ乳がん | III期中皮腫 | IV期中皮腫アメリカ
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Avid Radiopharmaceuticals完了
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First Hospital of China Medical University募集