Ultrasound and Near Infrared Imaging for Breast Cancer Diagnosis and Neoadjuvant Chemotherapy Monitoring
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Breast Cancer, Cancer |
| Therapuetic Areas: | Oncology |
| Healthy: | No |
| Age Range: | 18 - Any |
| Updated: | 3/24/2017 |
| Start Date: | March 2014 |
| End Date: | March 2017 |
An imaging method has been developed that uses near infrared light as an adjunct to
ultrasound for better diagnosis and for monitoring tumor response. This study will use a
new, non-invasive way to evaluate breast lumps using a low power light source & ultrasound
to see if breast lumps are benign or cancerous. This study will also evaluate if this new
technique might be useful in assessing response to chemotherapy.
ultrasound for better diagnosis and for monitoring tumor response. This study will use a
new, non-invasive way to evaluate breast lumps using a low power light source & ultrasound
to see if breast lumps are benign or cancerous. This study will also evaluate if this new
technique might be useful in assessing response to chemotherapy.
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.
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.
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.
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