Diagnostic US for Reduction of Benign Breast Biopsies Using US-guided Optical Tomography
| Status: | Recruiting |
|---|---|
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 2/17/2019 |
| Start Date: | December 13, 2018 |
| End Date: | November 30, 2023 |
| Contact: | Steven Poplack, M.D. |
| Email: | poplacks@mir.wustl.edu |
| Phone: | 314-454-7405 |
Improving Diagnostic US for Reduction of Benign Breast Biopsies Using US-guided Optical Tomography
Ultrasound-guided diffuse optical tomography (DOT) has demonstrated its potential role in
differentiating malignant and benign breast abnormalities and in predicting and monitoring
the neoadjuvant chemotherapy (NAC) response of breast cancer. This unique approach employs a
commercial ultrasound (US) transducer and near infrared (NIR) optical imaging sensors mounted
on a hand-held US probe. The co-registered US is used for lesion localization, and optical
sensors are used for imaging tumor related vascularity.
differentiating malignant and benign breast abnormalities and in predicting and monitoring
the neoadjuvant chemotherapy (NAC) response of breast cancer. This unique approach employs a
commercial ultrasound (US) transducer and near infrared (NIR) optical imaging sensors mounted
on a hand-held US probe. The co-registered US is used for lesion localization, and optical
sensors are used for imaging tumor related vascularity.
Inclusion Criteria:
- Female subjects ≥ 18 years old with ultrasound visible breast abnormalities referred
for ultrasound-guided core needle biopsy or fine needle aspiration
- Willing and able to provide informed consent
- Had contrast enhanced mammography (CEM) as Standard of Care imaging or willing to
undergo CEM (phase 1 subjects only)
Exclusion Criteria:
- Lesions located in the darkly pigmented nipple-areolar complex area
- Subjects with breast implants
- Abnormality in the mirror image location of the contralateral breast.
- Previous breast irradiation of the mirror image location of the contralateral breast
- Lesions located at previous biopsy sites when biopsy occurred within the last six
months.
- Small lesions of less than 1 cm located at skin or close to the skin
- Pregnancy
- Unwilling to have or undergo CEM (phase 1 subjects only)
We found this trial at
1
site
660 S Euclid Ave
Saint Louis, Missouri 63110
Saint Louis, Missouri 63110
(314) 362-5000
Principal Investigator: Steven Poplack, M.D.
Phone: 314-454-7405
Washington University School of Medicine Washington University Physicians is the clinical practice of the School...
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