STANDARDIZATION OF THE PROTOCOL FOR ATTENUATION COEFFICIENT MEASUREMENT
The assessment of liver fat content is important in patients suspected of or diagnosed with chronic liver disease. Non-alcoholic fatty liver disease (NAFLD) is defined by the presence of hepatic fat content ≥5% of hepatocytes. NAFLD is currently the most common chronic liver disease worldwide with an estimated prevalence of 5-30% in the general population and in 55% up to 80% of patients with type 2 diabetes. New ultrasound methods for a non-invasive and quantitative assessment of the liver fat content have recently been developed. They are based on the estimation of the attenuation coefficient of the ultrasound beam.
Our group has conducted studies to evaluate the performance of the attenuation coefficient available on the Aplio i800 ultrasound system (ATI, Canon Medical Systems). The Aplio i800 ultrasound system has already a CE mark, and is available at our Ultrasound Unit for research purposes. ATI has showed a high accuracy for the quantification of liver fat, and was more accurate than the controlled attenuation parameter (CAP, FibroScan) in assessing significant steatosis. The aim of the study is therefore the optimization of the acquisition protocol of ATI measurements on the system Aplio i800, which has already a CE mark.
調査の概要
状態
条件
研究の種類
入学 (実際)
連絡先と場所
研究場所
-
-
Pavia
-
Pavia、Pavia、イタリア、27100
- Fondazione IRCCS Policlinico San Matteo, SSD Malattie Infettive 3 - Ecografia
-
-
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:
- Informed consent
- Healthy adult volunteers (> 18 years)
- Ability to suspend respiration for image acquisition
Exclusion Criteria:
- Pregnancy
- age < 18 years
- Presence of ascites, acute viral hepatitis, transaminase flares, congestive heart failure, infiltrative diseases.
- No major medical conditions and in particular no known hepatic diseases
- Any other condition that, upon clinical judgment of the investigator, will make unacceptable the study participation for that individual subject
- Consent withdrawal
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 |
|---|---|---|
|
evaluation of the concordance of attenuation coefficient measurements taken with different technical approaches
時間枠:up to 3 years
|
Technical parameters considered are the position of the transducer, Breath-hold versus free breathing , Depth dependency, Intercostal approach vs subcostal vs left lobe, Separate acquisition of the attenuation coefficient versus simultaneous acquisition in "QUAD view" mode (stiffness / dispersion / ATI), Measurements of the attenuation coefficient using different ultrasound windows
|
up to 3 years
|
二次結果の測定
結果測定 |
時間枠 |
|---|---|
|
evaluation of the different parameters for measuring the attenuation coefficient determinates limits of agreement (LoA) that are larger than a pre-defined maximum allowed difference (Δ) in a Bland and Altman plot
時間枠:up to 3 years
|
up to 3 years
|
|
evaluation of the results and whether they are influenced by food intake
時間枠:up to 3 years
|
up to 3 years
|
|
evaluation of the results and whether they are influenced by the level of hydration
時間枠:up to 3 years
|
up to 3 years
|
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 (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 (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。