The Prone to Supine Breast MRI Trial
調査の概要
詳細な説明
The purpose of this study is to find out whether additional MRI images taken with patients in a different position after completing a standard MRI are of sufficient quality to allow a radiologist to identify the edges of the tumor.
These additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.The information gathered in this study will make it more feasible to use a new device called the "breast cancer locator" to help surgeons more accurately remove breast cancers.
研究の種類
入学 (実際)
段階
- 適用できない
連絡先と場所
研究場所
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New Hampshire
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Lebanon、New Hampshire、アメリカ、03756
- Dartmouth Hitchcock Medical Center
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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:
- Age > 18 years.
- Female gender.
- Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ
- Tumor size at least 1 cm in diameter as visualized on mammogram or US.
- A diagnostic breast MRI is considered to be clinically indicated.
- Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted.
Exclusion Criteria:
- Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes.
- Severe claustrophobia.
- Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy or compromised renal function (eGFR < 30 ml/min/1.73m2).
- History of median sternotomy.
- Pregnancy. Patient attestation that they are not pregnant will be acceptable.
- Patients who have received neoadjuvant chemotherapy.
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:他の
- 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 |
---|---|
実験的:Prone to Supine MRI
The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI.
Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI.
Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition.
Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.
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The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI.
Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI.
Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition.
Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.
|
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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Number of Successful Segmentation of Supine MRI Images
時間枠:30 minutes
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Determine what number of cases that can be successfully segmented both from using post-contrast prone MRI images and also from using post contrast supine MRI images.
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30 minutes
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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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Enhancement Quantification, as Measured by Signal Intensity - Segmented Tumor
時間枠:30 minutes
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Compare the signal intensity with that obtained at tumor location on the prone and supine imaging.
The amount of enhancement at the tumor site = segmented tumor.
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30 minutes
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Enhancement Quantification, as Measured by Signal Intensity - Tumor Boundary
時間枠:30 minutes
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Compare the signal intensity with that obtained in benign tissue surrounding the tumor on the prone and supine imaging.
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30 minutes
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Enhancement Quantification- Tumor-to-Background Ratio
時間枠:30 minutes
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Mean MRI signal of the segmented tumor divided by the mean MRI signal of the surrounding tissue which has an equal volume to the tumor.
The difference between tumor and benign breast tissue is the tumor-to-background ratio
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30 minutes
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Time to Position and Obtain Supine Images
時間枠:30 Minutes
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Calculate the additional time needed to obtain supine MRI images.
After the completion of Prone imaging, the patient was removed from the MRI, turned over to the supine position, new coils placed, and returned to the MRI for additional imaging.
The aggregate time to accomplish these tasks are noted in minutes.
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30 Minutes
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Overall Comfort for Prone and Supine Positions
時間枠:Within 15 minutes of the scan
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Quantify the perceived comfort level of the prone and supine MRI as reported by participants.
A single question using a Likert scale was was used.
The scale range was 0 to 5, where 0 = no pain, completely comfortable and 5 = considerable discomfort.
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Within 15 minutes of the scan
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協力者と研究者
捜査官
- 主任研究者:Timothy B Rooney, MD、Dartmouth-Hitchcock Medical Center
出版物と役立つリンク
一般刊行物
- Barth RJ Jr, Krishnaswamy V, Paulsen KD, Rooney TB, Wells WA, Rizzo E, Angeles CV, Marotti JD, Zuurbier RA, Black CC. A Patient-Specific 3D-Printed Form Accurately Transfers Supine MRI-Derived Tumor Localization Information to Guide Breast-Conserving Surgery. Ann Surg Oncol. 2017 Oct;24(10):2950-2956. doi: 10.1245/s10434-017-5979-z. Epub 2017 Aug 1.
- Leong CS, Daniel BL, Herfkens RJ, Birdwell RL, Jeffrey SS, Ikeda DM, Sawyer-Glover AM, Glover GH. Characterization of breast lesion morphology with delayed 3DSSMT: an adjunct to dynamic breast MRI. J Magn Reson Imaging. 2000 Feb;11(2):87-96. doi: 10.1002/(sici)1522-2586(200002)11:23.0.co;2-e.
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。
乳がんの臨床試験
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