Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using DOSI
Monitoring and Predicting Breast Cancer Neoadjuvant Chemotherapy Response Using Diffuse Optical Spectroscopic Imaging in a Multi-Center Setting
調査の概要
詳細な説明
There is considerable interest in developing imaging protocols to monitor and predict breast cancer response to neoadjuvant chemotherapy (NAC), which is chemotherapy given before surgical removal of the tumor, both prior to and as early as possible during the course of treatment. The efficacy and practicality of conventional imaging approaches in the NAC setting varies and identifies the need for alternate functional imaging strategies. Diffuse optical spectroscopic imaging (DOSI) is an experimental imaging method that allows patients to be followed before and during treatment with a cost-effective, bedside, handheld scanning probe. DOSI is a non-invasive technology developed at the University of California, Irvine Beckman Laser Institute. Studies will be performed at seven clinical sites on approximately 200 suspected breast cancer patients, of which 150 are expected to undergo neoadjuvant chemotherapy (NAC).
As a primary aim, the investigators will evaluate whether DOSI can predict NAC pathologic complete response (pCR), which is defined as no tumor cell left in the resected tissue at surgery) by the mid-point of the therapy regimen. As non-invasive DOSI is obtained rapidly with no risk/discomfort, this experimental imaging modality could be used as an indicator of pathologic response which has been an established indicator of long-term survival. The investigators long-term goal is to provide oncologists with a relatively simple, risk-free bedside tool that can be used to help inform medical decisions on chemotherapy regimen, duration, and timing of surgery, thereby maximizing therapeutic response and minimizing unnecessary toxicity.
研究の種類
段階
- 適用できない
連絡先と場所
研究場所
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California
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Costa Mesa、California、アメリカ、92627
- Pacific Breast Care Clinic
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Irvine、California、アメリカ、92612
- Beckman Laser Institute University of California Irvine
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Irvine、California、アメリカ、92612
- University of California, Irvine Medical Center
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San Francisco、California、アメリカ、94110
- University of California San Francisco
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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:
- Females between the ages of 21 and 80. Specific to Study part #1
- Diagnosed with a Breast Imaging-Reporting and Data System score of 4 or higher breast abnormality greater than 1cm in size Specific to Study part #2
- Enrolled in study part #1
- Diagnosed with histologically-proven invasive breast cancer
- Prescribed neoadjuvant chemotherapy for breast cancer
Exclusion Criteria:
- Pregnant
- Unable to give 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
- 主な目的:ヘルスサービス研究
- 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 |
|---|---|
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他の:DOSI
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Breast tissue properties scanning
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 |
時間枠 |
|---|---|
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Concentration of oxy-hemoglobin (HbO2), in blood.
時間枠:through study completion, an average of 3 years
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through study completion, an average of 3 years
|
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Concentration of deoxy-hemoglobin (HHb) in blood.
時間枠:through study completion, an average of 3 years
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through study completion, an average of 3 years
|
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Concentration of total hemoglobin in blood.
時間枠:through study completion, an average of 3 years
|
through study completion, an average of 3 years
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Water content of tissue (%)
時間枠:through study completion, an average of 3 years
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through study completion, an average of 3 years
|
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Bulk lipid in tissue (%)
時間枠:through study completion, an average of 3 years
|
through study completion, an average of 3 years
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協力者と研究者
捜査官
- 主任研究者:Bruce J Tromberg, PhD、Beckman Laser Institute
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 (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
本研究に関する用語
その他の研究ID番号
- 20152355
個々の参加者データ (IPD) の計画
個々の参加者データ (IPD) を共有する予定はありますか?
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