DLSCT for Breast Cancer Detection in Women With Dense Breasts (DECREAS)
Dual-layer Spectral Computerized Tomography for Breast Cancer Detection in Women With Dense Breasts: a Single Centre, Feasibility Study - The DECREAS Study
The main objective of this project is to demonstrate the feasibility of DLSCT to detect breast cancer in women with dense breasts.
Patients with locoregional advanced primary breast cancer and heterogeneously (n = 7) or extremely dense breasts (n = 7) as determined by mammography will be included in this study. These patients have an indication for a positron emission tomography computed tomography (PET-CT) scan to search for distant metastases. In this study the participants will undergo an additional contrast enhanced DLSCT scan to determine the feasibility of spectral CT to detect breast cancer in women with dense breasts.
調査の概要
状態
研究の種類
入学 (予想される)
連絡先と場所
研究連絡先
- 名前：Carla M Meeuwis, MD,PhD
- 電話番号：+31 26 378 8888
- メール：cmeeuwis@rijnstate.nl
研究場所
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Arnhem、オランダ
- 募集
- Rijnstate Hospital
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コンタクト：
- Carla A Meeuwis, MD, PhD
- メール：cmeeuwis@rijnstate.nl
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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:
Diagnosis of histopathologically proven locoregional advanced primary breast cancer:
- Tumors > 5 cm (= T3) or
- Tumors with invasion of the skin or chest wall (= T4) or
- Any tumor with ≥ 4 axillary lymph nodes or ipsilateral internal mammary, infraclavicular or supraclavicular nodal involvement (= N2-3)
- Heterogeneously or extremely dense breasts as described by visual assessment on full-field digital mammograms: category C or D according to the ACR BI-RADS lexicon
Exclusion Criteria:
- History of allergic reactions to iodinated contrast agents
- Pregnancy or breast feeding
- Treatment of thyroid disease with radioactive iodine
- Use of metformin
- Creatinine clearance < 45 ml/min
- Chronic or acutely worsening renal disease
- Patients who are declared incompetent
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 |
|---|---|---|
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Visual tumor conspicuity
時間枠：On the same 1 day as the regular PET-CT scan was performed
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The conspicuity of tumors will be graded on a 4-point confidence scale
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On the same 1 day as the regular PET-CT scan was performed
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BI-RADS score
時間枠：On the same 1 day as the regular PET-CT scan was performed
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BI-RADS score according to the ACR BI-RADS lexicon
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On the same 1 day as the regular PET-CT scan was performed
|
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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Iodine enhancement
時間枠：On the same 1 day as the regular PET-CT scan was performed
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Iodine enhancement will be measured in Hounsfield Units (HU).
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On the same 1 day as the regular PET-CT scan was performed
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Iodine content
時間枠：On the same 1 day as the regular PET-CT scan was performed
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Iodine content will be measured mg/mL.
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On the same 1 day as the regular PET-CT scan was performed
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Laura N Deden、Rijnstate Hospital
- 主任研究者：Maxime V.P. Schyns, MD、Rijnstate Hospital
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 (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。