Optical Tomography With Ultrasound Guidance
3-D Simultaneous Ultrasound and NIR Imaging for Breast Cancer Detection
The investigators propose to validate the utility of their 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 optical tomography.
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 small group of patients who underwent biopsy 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.
The 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.
調査の概要
状態
条件
詳細な説明
Specific objectives of the study are:
Objective 1: Validate the sensitivity, specificity, positive predictive value and negative predictive value of optical tomography/US for distinguishing benign and early stage malignant breast tumors. Approximately 300 patients who will undergo ultrasound-guided biopsy are being recruited to this study from the University of Connecticut Health Center and Hartford Hospital. The total hemoglobin concentration and blood oxygen saturation will be the measured indices and the biopsy results will be used as the 'gold' standard.
Objective 2: Perform pilot studies of optical tomography/US to assess chemotherapy response and evaluate treatment efficacy. Patients diagnosed with locally advanced breast cancers (size greater than 3 cm) who will undergo chemotherapy will be enrolled to this study. Approximately, 20 to 30 patients are being recruited to the study from the University of Connecticut Health Center and Hartford Hospital.
研究の種類
入学 (実際)
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、06030
- University of Connecticut Health Center
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Hartford、Connecticut、アメリカ、06102
- Hartford Hospital
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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
- Women undergo ultrasound guided biopsy
- Breast cancer patients undergo neoadjuvant thermotherapy treatment
説明
Inclusion Criteria:
- Women undergoing ultrasound guided biopsy or breast cancer patients undergoing neoadjuvant thermotherapy treatment
Exclusion Criteria:
- Women under 18 years old.
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
- 観測モデル：コホート
- 時間の展望：見込みのある
コホートと介入
グループ/コホート |
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1
Patients who undergo routine ultrasound guided biopsy will be studied by optical imaging technique.
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2
Patients who have advanced breast cancers and are under neoadjuvant chemotherapy treatment will be studied by optical technique.
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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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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.
時間枠：4 more years
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4 more years
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協力者と研究者
スポンサー
協力者
捜査官
- 主任研究者：Quing Zhu, Ph.D、University of Connecticut
出版物と役立つリンク
一般刊行物
- Zhu Q, Hegde PU, Ricci A Jr, Kane M, Cronin EB, Ardeshirpour Y, Xu C, Aguirre A, Kurtzman SH, Deckers PJ, Tannenbaum SH. Early-stage invasive breast cancers: potential role of optical tomography with US localization in assisting diagnosis. Radiology. 2010 Aug;256(2):367-78. doi: 10.1148/radiol.10091237. Epub 2010 Jun 22.
- Xu Y, Zhu Q. Imaging heterogeneous absorption distribution of advanced breast cancer by optical tomography. J Biomed Opt. 2010 Nov-Dec;15(6):066007. doi: 10.1117/1.3505015.
- Xu C, Zhu Q. Light shadowing effect of large breast lesions imaged by optical tomography in reflection geometry. J Biomed Opt. 2010 May-Jun;15(3):036003. doi: 10.1117/1.3431086.
- Ardeshirpour Y, Huang M, Zhu Q. Effect of the chest wall on breast lesion reconstruction. J Biomed Opt. 2009 Jul-Aug;14(4):044005. doi: 10.1117/1.3160548.
- Xu C, Yuan B, Zhu Q. Optimal probe design for breast imaging using near-infrared diffused light. J Biomed Opt. 2008 Jul-Aug;13(4):044002. doi: 10.1117/1.2966703.
- Zhu Q, Tannenbaum S, Hegde P, Kane M, Xu C, Kurtzman SH. Noninvasive monitoring of breast cancer during neoadjuvant chemotherapy using optical tomography with ultrasound localization. Neoplasia. 2008 Oct;10(10):1028-40. doi: 10.1593/neo.08602.
- Zhu Q, Wang L, Tannenbaum S, Ricci A Jr, DeFusco P, Hegde P. Pathologic response prediction to neoadjuvant chemotherapy utilizing pretreatment near-infrared imaging parameters and tumor pathologic criteria. Breast Cancer Res. 2014 Oct 28;16(5):456. doi: 10.1186/s13058-014-0456-0.
- Tavakoli B, Zhu Q. Two-step reconstruction method using global optimization and conjugate gradient for ultrasound-guided diffuse optical tomography. J Biomed Opt. 2013 Jan;18(1):16006. doi: 10.1117/1.JBO.18.1.016006.
- Zhu Q, DeFusco PA, Ricci A Jr, Cronin EB, Hegde PU, Kane M, Tavakoli B, Xu Y, Hart J, Tannenbaum SH. Breast cancer: assessing response to neoadjuvant chemotherapy by using US-guided near-infrared tomography. Radiology. 2013 Feb;266(2):433-42. doi: 10.1148/radiol.12112415. Epub 2012 Dec 21.
研究記録日
主要日程の研究
研究開始
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
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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