Annual MRI Versus Biannual US for Surveillance of Hepatocellular Carcinoma in Liver Cirrhosis (MAGNUS-HCC)
Comparison of Biannual Ultrasonography and Annual Unenhanced Magnetic Resonance Imaging as a Surveillance Test for Hepatocellular Carcinoma in Patients With Liver Cirrhosis
調査の概要
詳細な説明
Hepatocellular carcinoma (HCC) is one of the major complications in patients with chronic liver disease. The prognosis of HCC relies on the extent of disease at the time of diagnosis. Hence to detect cancer at an earlier stage, a regular surveillance test is important for the subjects with a high risk of developing cancer. Current guidelines recommend a regular surveillance using ultrasonography (US) at a 6 month-interval. Ultrasonography is a non-invasive and safe procedure, yet it is limited by the skills of the operator and it is often difficult to differentiate cancer from regenerating nodules especially in atrophied cirrhotic liver. According to a recent meta-analysis, the overall sensitivity and specificity of detecting liver cancer using ultrasonography were both over 90%, however the sensitivity was decreased to 60% in detecting early lesions in which surgery or liver transplantation is indicated. Of note, addition of alpha feto protein(AFP) to ultrasonography also failed to increase the sensitivity in detecting small cancers. Taken together, there is a need to develop a new surveillance test with an improved sensitivity and specificity.
Recently, a retrospective study reported that CT or MRI showed a better sensitivity than ultrasonography in detecting early liver cancer. However, performing CT as a surveillance test is limited by frequent exposure to radiation and contrast-dye agent. Although MRI does not have the risk of radiation-exposure, it is limited by the high cost and limited availability. On the contrast, non-contrast MRI offers a cost that is comparable to US and an absence of exposure to radiation or contrast-dye agent, which suggests non-contrast MRI as a good alternative surveillance tool for early detection of HCC. Therefore, in this prospective trial, the investigators will investigate the usefulness of biannual ultrasonography versus annual non-contrast magnetic resonance imaging for surveillance of hepatocellular carcinoma.
研究の種類
入学 (実際)
連絡先と場所
研究場所
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Seoul、大韓民国
- Seoul National University Hospital
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Seoul、大韓民国
- Samsung Medical Center
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Seoul、大韓民国、06591
- Seoul St.Mary's Hospital
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Seoul、大韓民国
- Korean University Guro Hospital
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Suwon、大韓民国
- St.Vincent's Hospital
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Uijeongbu、大韓民国
- Uijeongbu St.Mary's Hospital
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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
サンプリング方法
調査対象母集団
説明
Inclusion Criteria:
- Male or female subject older than 40 years of age at the enrollment
- Fulfill below conditions A and B
A. The evidence of cirrhosis of any etiology within 12 months prior to screening Definition of cirrhosis by any of following methods
- Histologically by liver biopsy;
Non-histologically by evidence of portal hypertension in the presence of chronic liver disease;
Evidence of portal hypertension, including any of followings;
- The identification of splenomegaly on ultrasonography, CT, or MRI examinations with typical features of cirrhosis
- The identification of esophageal or gastric varices on endoscopic examination
B. Risk Index larger than 2.33; Risk Index = 1.65 (if the prothrombin activity is <=75%) + 1.41 (if the age is 50 years or older) + 0.92 (if the platelet count is <=100,000/mm3) + 0.74 (if the presence of HCV is positive).
Exclusion Criteria:
- Presence of liver cancer or other intrahepatic malignancy
- Has a history of malignancy within previous 5 years
- Is pregnant or breast-feeding
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
コホートと介入
グループ/コホート |
介入・治療 |
|---|---|
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Study
Surveillance of HCC by biannual ultrasonography AND annual noncontrast MRI
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liver MRI without contrast agents T2 weighted image, T1 in/out of phase, diffusion weighted images with b-values of 0, 500 mm2/s
liver ultrasonography for HCC screening performed by experienced sonologists
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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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sensitivity for detecting HCC
時間枠：3 years
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sensitivity for detecting HCC
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3 years
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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 |
|---|---|---|
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survival of the patients who developed HCC on follow-up period
時間枠：years
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survival of the patients who developed HCC on follow-up period
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years
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false referral rate for HCC
時間枠：3 years
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false referral rate for HCC
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3 years
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Joon-Il Choi、Seoul St. Mary's hospital
出版物と役立つリンク
一般刊行物
- Kim YK, Kim YK, Park HJ, Park MJ, Lee WJ, Choi D. Noncontrast MRI with diffusion-weighted imaging as the sole imaging modality for detecting liver malignancy in patients with high risk for hepatocellular carcinoma. Magn Reson Imaging. 2014 Jul;32(6):610-8. doi: 10.1016/j.mri.2013.12.021. Epub 2014 Jan 13.
- Kim HA, Kim KA, Choi JI, Lee JM, Lee CH, Kang TW, Ku YM, Lee SL, Park YS, Yoon JH, Kim SH, Choi MH. Comparison of biannual ultrasonography and annual non-contrast liver magnetic resonance imaging as surveillance tools for hepatocellular carcinoma in patients with liver cirrhosis (MAGNUS-HCC): a study protocol. BMC Cancer. 2017 Dec 21;17(1):877. doi: 10.1186/s12885-017-3819-y.
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 (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。
annual noncontrast MRIの臨床試験
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Cambridge University Hospitals NHS Foundation Trust募集
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Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)終了しました
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Assistance Publique Hopitaux De Marseille積極的、募集していない
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Vanderbilt-Ingram Cancer CenterNational Cancer Institute (NCI)終了しました成人未分化星細胞腫 | 成人未分化上衣腫 | 成人未分化乏突起膠腫 | 成人巨細胞性膠芽腫 | 成人膠芽腫 | 成人神経膠肉腫 | 再発成人脳腫瘍アメリカ
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Assistance Publique - Hôpitaux de Parisわからない