肝転移検出のための肝臓MRにおける造影剤の比較
肝転移の検出のためのガドキセト酸二ナトリウムによる肝臓 MR と比較した、短縮ガドベン酸ジメグルミン肝胆道相プロトコルによる肝臓 MR の評価
If an abbreviated hepatobiliary phase (HBP) protocol liver MR with gadobenate dimeglumine is shown clinically comparable to standard of care liver MR with gadoxetate disodium for detecting hepatic metastasis from colorectal cancer, its use will save time, cost, and patients' effort.
調査の概要
詳細な説明
The goal is to:
- Estimate and compare the diagnostic performance, including sensitivity, specificity, positive/negative predictive value, and area under the receiver operating characteristics (AUROC), of abbreviated protocol liver magnetic resonance (MR) with hepatobiliary phase (HBP) using gadobenate dimeglumine for detecting liver metastases, with 1) abbreviated protocol liver MR with HBP using gadoxetate disodium, 2) standard of care complete protocol liver MR using gadoxetate disodium, and 3) complete protocol liver MR using gadobenate dimeglumine.
- Estimate and compare quantitative measures of HBP images (liver enhancement ratio, lesion contrast to noise and signal to noise ratios [CNR and SNR]) for both gadobenate dimeglumine and gadoxetate disodium.
- Qualitatively assess the preference, or lack thereof, of radiologists regarding the images generated by abbreviated protocol liver MR with HBP using gadobenate dimeglumine versus abbreviated protocol liver MR with HBP using gadoxetate disodium.
研究の種類
入学 (実際)
段階
- フェーズ 4
連絡先と場所
研究場所
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Colorado
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Aurora、Colorado、アメリカ、80045
- University of Colorado 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
説明
Inclusion Criteria:
- Colorectal cancer patients
- Age 18-80 years
- No prior treatment including surgery
- Prior imaging with suspected liver metastasis
Exclusion Criteria:
- Age < 18 years or > 80 years
- eGFR < 30 ml/min/1.73 m2
- Previous reaction to gadolinium contrast agents
- History of claustrophobia or movement disorders likely to impact image quality
- Non-MR safe implants or metallic foreign bodies
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：ランダム化
- 介入モデル：クロスオーバー割り当て
- マスキング：独身
武器と介入
参加者グループ / アーム |
介入・治療 |
|---|---|
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アクティブコンパレータ：Gadoxetate disodium exam first, Gadobenate Dimeglumine exam second
The subjects will be randomized into two groups. Both groups will undergo two complete protocol liver magnetic resonance imaging (MRI) for known or suspected colorectal cancer (CRC) metastasis, one exam with gadoxetate disodium and the other exam with gadobenate dimeglumine, within an interval of 3-20 days, but in opposite order, determined randomly. |
Gadoxetate disodium MR contrast is now mainly used for the purpose of HBP liver MR imaging to save MR scanner time and total examination time.
他の名前：
The most commonly used MR contrast agent in abdominal imaging is gadobenate dimeglumine, which has mainly the characteristics of an extracellular agent used for most indications of MR examinations.
他の名前：
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実験的：Gadobenate Dimeglumine exam first, Gadoxetate disodium exam second
The subjects will be randomized into two groups. Both groups will undergo two complete protocol liver MRI for known or suspected CRC metastasis, one exam with gadoxetate disodium and the other exam with gadobenate dimeglumine, within an interval of 3-20 days, but in opposite order, determined randomly. |
Gadoxetate disodium MR contrast is now mainly used for the purpose of HBP liver MR imaging to save MR scanner time and total examination time.
他の名前：
The most commonly used MR contrast agent in abdominal imaging is gadobenate dimeglumine, which has mainly the characteristics of an extracellular agent used for most indications of MR examinations.
他の名前：
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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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Preference of Radiologists for the Hepatobiliary Phase Images Generated by MultiHance (amHBP) Versus Eovist (aeHBP).
時間枠：1 month
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The quality of amHBP and aeHBP images was assessed using ordinal response mixed effect models that included right/left image position as a covariate. For each paired comparison, radiologists indicated their preferred hepatobiliary phase image. |
1 month
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Quantitative Timing Measures for Hepatobiliary Phase MRI
時間枠：1 month
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Measures of timing used to obtain hepatobiliary phase images. |
1 month
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Estimate and Compare Quantitative Measures of HBP Images (Liver Enhancement Ratio, Lesion Contrast to Noise and Signal to Noise Ratios [CNR and SNR]) for Both Gadobenate Dimeglumine and Gadoxetate Disodium.
時間枠：1 month
|
A single reader analyzed paired Eovist and MultiHance hepatobiliary phase images (N=10 paired datasets). Quantitative metrics included liver-to-metastasis, liver-to-spleen, liver-to-muscle, and liver-to-blood contrast ratios (CNR's), as well as liver signal-to-noise ratio (SNR). All CNR's were calculated as signal intensity of liver relative to the reference tissue, with liver SNR liver signal/liver noise. Higher contrast ratios and higher SNR values indicate greater liver enhancement and improved lesion conspicuity. |
1 month
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Estimate and Compare Qualitative Measures of HBP Images for Both Gadobenate Dimeglumine and Gadoxetate Disodium.
時間枠：1 month
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A single reader performed a qualitative assessment of Dynamic and Hepatobiliary Phase Image Quality (Likert scale 1-5) for both Eovist and MultiHance Hepatobiliary Phase images (N=10 paired data). Higher scores indicate better image quality. |
1 month
|
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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Diagnostic Performance of Gadobenate Dimeglumine
時間枠：1 year
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The primary performance diagnostic will be sensitivity, similar to the recently published retrospective study by Canellas et al. (2019). In addition to other diagnostic performance metrics of interest (e.g., specificity, AUROC), lesions will be analyzed descriptively in terms of number of metastases detected and lesion size. |
1 year
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Compare Sensitivity and Specificity,
時間枠：17 months
|
The primary analysis will use pathology as the gold standard, if available, but will revert to long term imaging in the absence of pathology. To address the potential impact of this limitation, we will also conduct an exploratory analysis to compare the sensitivity and specificity of the imaging methods by each gold standard. |
17 months
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Test Validity of Imaging Methods
時間枠：17 months
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We will also conduct an exploratory analysis to test the validity of long term imaging as a gold standard against available pathology reports. |
17 months
|
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Compare Patient Time Associated With Imaging Method
時間枠：17 months
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In addition to analyses for the primary aims, additional analyses will be conducted to examine patient time associated with each imaging method; time metrics can be compared between imaging methods in absolute terms, but also proportionally to sensitivity. |
17 months
|
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Compare Cost Associated With Imaging Method
時間枠：17 months
|
In addition to analyses for the primary aims, additional analyses will be conducted to examine cost associated with each imaging method; cost metrics can be compared between imaging methods in absolute terms, but also proportionally to sensitivity. |
17 months
|
協力者と研究者
捜査官
- 主任研究者：Nikhil Madhuripan, MD、University of Colorado, Denver
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
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