Ultrasound and Near Infrared Imaging for Breast Cancer Diagnosis and Neoadjuvant Chemotherapy Monitoring

NCT ID: NCT02092636

Last Updated: 2017-04-26

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2014-03-31
• Study Completion Date: 2017-02-28

Brief Summary

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.

Detailed Description

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

NIR/US Diagnostic Group

Intervention Type: OTHER

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.

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.

Group Type: EXPERIMENTAL

NIR/US Neoadjuvant Chemotherapy Group

Intervention Type: OTHER

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.

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.

Group Type: OTHER

NIR/US Process Validation Group

Intervention Type: OTHER

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.

Interventions

NIR/US Diagnostic Group

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.

Intervention Type: OTHER

NIR/US Neoadjuvant Chemotherapy Group

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.

Intervention Type: OTHER

NIR/US Process Validation Group

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.

Intervention Type: OTHER

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

National Institute for Biomedical Imaging and Bioengineering (NIBIB)

NIH

Sponsor Role: collaborator

UConn Health

OTHER

Sponsor Role: lead

Responsible Party

Susan Tannenbaum

Associate Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Susan Tannenbaum, MD

Role: PRINCIPAL_INVESTIGATOR

UConn Health

Locations

UConn Health

Farmington, Connecticut, United States

Countries

United States

References

Zhu Q, Tannenbaum S, Kurtzman SH, DeFusco P, Ricci A Jr, Vavadi H, Zhou F, Xu C, Merkulov A, Hegde P, Kane M, Wang L, Sabbath K. Identifying an early treatment window for predicting breast cancer response to neoadjuvant chemotherapy using immunohistopathology and hemoglobin parameters. Breast Cancer Res. 2018 Jun 14;20(1):56. doi: 10.1186/s13058-018-0975-1.

Reference Type: DERIVED

PMID: 29898762 (View on PubMed)

Other Identifiers

R01EB002136

Identifier Type: NIH

Identifier Source: secondary_id

View Link

12-194-6

Identifier Type: -

Identifier Source: org_study_id