TOBI to Monitor Response to Neoadjuvant Therapy in Breast Cancer

Steven Isakoff, MD, PhD

Status: Completed

Conditions: Breast Cancer

Treatments: Device: Optical Imaging

Study type: Interventional

Funder types: Other

Identifiers

NCT00783757

07-305

Details and patient eligibility

About

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.

Full description

• 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.

Enrollment: 30 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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30 participants in 1 patient group

Optical Imaging

Experimental group

Description:

Tomographic Optical Imaging Arm

Treatment:

Device: Optical Imaging