Ultrasound and Near Infrared Imaging for Breast Cancer Diagnosis and Neoadjuvant Chemotherapy Monitoring
調査の概要
状態
条件
詳細な説明
The investigators propose to validate the utility of the investigators novel hybrid imaging technique for accurate diagnosis of breast lesions, and for assessing chemotherapy response of cancer treatment and predicting treatment efficacy. The investigators unique hybrid technique is implemented by simultaneously deploying near infrared (NIR) optical sensors and a commercial ultrasound (US) transducer mounted on a hand-held probe, and utilizing co-registered lesion structure information provided by ultrasound to improve the inverse optical tomography reconstruction. As a result, the optical tomography assisted with US has overcome problems associated with intense light scattering and has provided reliable tumor angiogenesis distributions. Initial results with a group of 200 biopsied patients have shown that early stage invasive cancers present two-fold greater total hemoglobin concentration on average than fibroadenomas and other benign lesions. Initial results of advanced cancers have shown that the angiogenesis distribution is highly distorted and heterogeneous, and the distorted distributions correlate with histological microvessel density counts and can be used to assess chemotherapy response.
Objective of this study is to validate the investigators initial results that NIR light guided by ultrasound can improve breast cancer diagnosis and monitor chemotherapy response.
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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Connecticut
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Farmington、Connecticut、アメリカ、06032
- UConn Health
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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:
- Women aged 18 years and older who have breast lumps or abnormalities (actual or suspected) are eligible for the study.
- Women and members of all races and ethnic groups are eligible for this study.
- Diagnostic Group: These patients will include women who have breast lumps/lesions visible by ultrasound and are prescribed follow up with an ultrasound-guided biopsy at the UCHC Cancer Center for evaluation and diagnosis of actual/suspected breast abnormalities.
- Neoadjuvant Chemotherapy Group: These patients will include women who have breast lumps/lesions visible by ultrasound and have been diagnosed with breast cancers and will undergo neoadjuvant chemotherapy. These patients may be identified from the diagnostic group or after initial diagnosis. Patients will only be enrolled to one of the two groups.
- Process Validation Group: This group will contain data from about five women who did not have ultrasound visible lumps on the day of the planned biopsy. Data from the NIR/US scan will be used to validate instrument measurements.
Exclusion Criteria:
- All Subjects who fail to meet the inclusion criteria are ineligible for the study.
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：非ランダム化
- 介入モデル：並列代入
- 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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実験的：NIR/US Diagnostic Group
These patients will include women who have breast lumps/lesions visible by ultrasound and are prescribed follow up with an ultrasound-guided biopsy at the UCHC Cancer Center for evaluation and diagnosis of actual/suspected breast abnormalities.
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Patients receiving an ultrasound-guided biopsy will participate in one study visit on the day of the biopsy.
The NIR/US scan will be completed immediately prior to the biopsy procedure and takes about 5-10 minutes to perform.
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実験的：NIR/US Neoadjuvant Chemotherapy Group
These patients will include women who have breast lumps/lesions visible by ultrasound and have been diagnosed with breast cancers and will undergo neoadjuvant chemotherapy.
These patients may be identified from the diagnostic group or after initial diagnosis.
Patients will only be enrolled to one of the two groups.
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Patients may have the NIR/US scan performed at the time of their initial ultrasound-guided biopsy.
In addition, patients in this group may also have NIR/US performed according the schedule in Table 1.
The number of NIR/US study visits for these subjects will vary from 1-11 depending on the subject's treatment regimen.
The expected duration of study participation for these patients is approximately 6 months.
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他の：NIR/US Process Validation Group
This group will contain data from about five women who did not have ultrasound visible lumps on the day of the planned biopsy.
Data from the NIR/US scan will be used to validate instrument measurements.
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Patients who present with visible lumps at initial ultrasound but do not have ultrasound visible lumps on the day of the biopsy procedure will not require a biopsy.
NIR/US scan will be performed.
Data from the NIR/US scan will be used to validate instrument measurements.
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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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Hemoglobin concentration
時間枠：5 years
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The deoxygenated/oxygenated hemoglobin and total hemoglobin concentration are the measured imaging parameters and biopsy results will be used as the 'gold' standard to compare imaging findings.
Hemoglobin concentration is measured in micromolar/liter.
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5 years
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協力者と研究者
スポンサー
捜査官
- 主任研究者：Susan Tannenbaum, MD、UConn Health
出版物と役立つリンク
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 (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
- 12-194-6
- R01EB002136 (米国 NIH グラント/契約)
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?
IPD プランの説明
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