TOBI to Monitor Response to Neoadjuvant Therapy in Breast Cancer

Study Overview
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Brief Summary
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The purpose of this research study is to see if Near-Infrared Tomographic Optical Breast Imaging (TOBI) scans can help monitor breast tumor response during treatment for breast cancer. The images created by the TOBI scan show changes in blood blow and oxygen levels in breast tissue.

Detailed Description
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Participants will have a TOBI scan prior to starting their cancer treatment and again on day 8 after their first treatment. Participants will also be asked if they would volunteer to undergoing one or more additional TOBI scans on days 2-7 after they begin cancer treatment. These additional scans are optional. Participants will also have a scan on the first day of each treatment cycle. TOBI scans will be performed at the Gillette Center for Breast Cancer at the Massachusetts General Hospital. For the scan, each breast is placed between 2 plastic plates in order to spread the tissue apart, similar to the procedure for a mammogram. The TOBI scanner is attached to these plates. We will apply mild pressure to compress the breast and the breast will be scanned using light waves. Each scan will take about 3 minutes.

Official Title
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Functional Metabolic Near-infrared Tomographic Optical Breast Imaging (TOBI) to Monitor Response to Neoadjuvant Therapy in Breast Cancer

Conditions
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Breast Cancer

Intervention / Treatment
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* Device: Optical Imaging


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Adult female patients presenting to the MGH Cancer Center Gillette Center for breast cancer neoadjuvant therapy Subject who have had or will have a clinically indicated pre-treatment breast MRI Exclusion Criteria: Younger than 18 years of age Open wounds on breast Breast implants, because they may interfere with readings Subjects who will be receiving preoperative therapy for <28 days Breast surgery or biopsy < 10 days prior to optical imaging scan Medical or psychiatric or other medical condition that the principal investigator believes may result in inability to complete the study Bilateral breast cancers or a history of contralateral breast cancer

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Device Feasibility
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Optical Imaging<br>Tomographic Optical Imaging Arm | Device: Optical Imaging<br>* TOBI scan performed before the participant starts cancer treatment and at the start of each treatment cycle<br>* Other names: TOBI;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore the feasibility of measuring optically derived parameters in the clinical setting. |  | 4 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| To explore the changes before and after neoadjuvant therapy of additional parameters derived from dynamic and static optical imaging of primary breast cancer. |  | 4 years | 
| To evaluate changes in optical imaging-derived deoxyhemoglobin concentration early in treatment in patients undergoing neoadjuvant therapy for breast cancer. |  | 4 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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neo-adjuvant chemotherapy, TOBI, breast imaging, optical imaging