Digital Breast Tomosynthesis Versus Digital Mammography: A National Multicenter Trial
Digital Breast Tomosynthesis vs. Digital Mammography: A National Multicenter Trial
The goal of this study is to determine the value of the new mammography technique called Digital Breast Tomosynthesis (DBT) compared to the current standard technique Digital Mammography for the early detection of Breast Cancer.
DBT is able to compute a three-dimensional image of a breast from several low-dose mammographies taken from different angles while the device is moving around the breast in a circular motion. This should overcome a significant limitation of Digital Mammography arising from the masking of breast cancer in a mammography image caused by overlying normal breast tissue.
This is a study conducted in several Austrian Breast Imaging Centers.
調査の概要
状態
条件
詳細な説明
This prospective national multicenter multivendor trial aims at determining the impact of the novel technique Digital Breast Tomosynthesis (DBT) in the assessment and screening for breast cancer. Mammography is the primary imaging modality for the early detection of clinically occult breast cancer.
Despite advances in mammographic technique, mammography is still limited with regard to both sensitivity and specificity. In the majority of cases these limitations arise from the masking of subtle breast cancer lesions by overlapping breast tissue.
DBT is a novel technique that tries to overcome these limitations by performing a 3D-reconstruction of breast tissue from multiple low-dose digital mammographic images acquired in several planes in a 15 to 50 degree angle.
Early studies indicate an advantage of DBT compared to the standard Full Field Digital Mammography (FFDM) in terms of an improvement of specificity without cutback in sensitivity.
Controversy continues over the use of DBT in combination with FFDM or as a standalone screening method without concomitant 2D imaging. Unfortunately, the peer-reviewed publications evaluating DBT are limited and consist of single institution studies with a small number of participants.
The purpose of this study is to evaluate the novel technique of DBT compared to routine FFDM in a clinical large sample study (600 participants) to provide the path to implementation of this new technique into clinical and screening routine.
研究の種類
入学 (予想される)
連絡先と場所
研究場所
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Vienna、オーストリア、A-1090
- 募集
- Medical University of Vienna
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コンタクト:
- Thomas Moritz, MD
- 電話番号:4818 +43140400
- メール:thomas.moritz@meduniwien.ac.at
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Vienna、オーストリア、A-1100
- 募集
- Kaiser Franz Josef Spital
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コンタクト:
- Gabrielle Kienzer, MD
- 電話番号:3608 +43160191
- メール:Gabrielle.kienzer@wienkav.at
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Vienna、オーストリア、A-1140
- 募集
- Hanusch Krankenhaus
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コンタクト:
- Reinhard Bernt, MD
- 電話番号:86630 +43191021
- メール:reinhard.bernt@wgkk.at
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Styria
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Graz、Styria、オーストリア、A-8036
- 募集
- Medical University of Graz
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コンタクト:
- Sabine Oswald, MD
- 電話番号:13850 +43 316385
- メール:sabine.oswald@klinikum-graz.at
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Upper Austria
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Wels、Upper Austria、オーストリア、A-4600
- 募集
- Klinikum Wels-Grieskirchen
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コンタクト:
- Stefan Meindl, MD
- 電話番号:2413 +437242415
- メール:stefan.meindl@klinikum-wegr.at
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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
The study population consists of two groups:
One screening group consisting of asymptomatic women (Age 40+) referred for a screening mammography examination.
The second group consists of women aged 25+ referred for further examination of a breast lesion.
説明
Inclusion Criteria:
- Age > 25 years (40 years or older for Screening Cohort)
- No history of breast cancer
- Written informed consent
- Asymptomatic women in follow up for early detection of breast cancer or
- Patients with a recent positive mammography (BI-RADS 3-5)
Exclusion Criteria:
- Pregnant and breast feeding women
- Unable to tolerate breast compression
- Breast implants
- Unable to understand or execute written informed consent
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 |
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Breast Cancer Screening Patients
Group 1 consists of Women referred to Breast Cancer Screening examinations at a participating Austrian Breast Imaging Site
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Diagnostic Patients
Patients referred to a participating Breast Imaging Center for a clinically or radiologically detected breast lesion
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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 |
時間枠 |
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Specificity of Digital Breast Tomosynthesis in the characterization of Breast lesions
時間枠:One year
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One year
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二次結果の測定
結果測定 |
時間枠 |
---|---|
Sensitivity of Digital Breast Tomosynthesis in the detection of malignant breast lesions
時間枠:One year
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One year
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協力者と研究者
捜査官
- 主任研究者:Thomas Moritz, MD、Medical University of Vienna
- スタディディレクター:Thomas Helbich, MD Prof. MBA MSc、Medical University of Vienna
研究記録日
主要日程の研究
研究開始
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 (見積もり)
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
本研究に関する用語
その他の研究ID番号
- TomoTrial001
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。
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