TOBI to Monitor Response to Neoadjuvant Therapy in Breast Cancer
- Conditions
- Breast Cancer
- Interventions
- Device: Optical Imaging
- Registration Number
- NCT00783757
- Lead Sponsor
- Steven Isakoff, MD, PhD
- Brief Summary
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
* 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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- Female
- Target Recruitment
- 30
- 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
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Optical Imaging Optical Imaging Tomographic Optical Imaging Arm
- Primary Outcome Measures
Name Time Method To explore the feasibility of measuring optically derived parameters in the clinical setting. 4 years
- Secondary Outcome Measures
Name Time Method 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
Trial Locations
- Locations (1)
Massachusetts General Hospital
🇺🇸Boston, Massachusetts, United States