TOBI to Monitor Response to Neoadjuvant Therapy in Breast Cancer
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.
|Study Design:||Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
|Official Title:||Functional Metabolic Near-infrared Tomographic Optical Breast Imaging (TOBI) to Monitor Response to Neoadjuvant Therapy in Breast Cancer|
- To explore the feasibility of measuring optically derived parameters in the clinical setting. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- To explore the changes before and after neoadjuvant therapy of additional parameters derived from dynamic and static optical imaging of primary breast cancer. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
- To evaluate changes in optical imaging-derived deoxyhemoglobin concentration early in treatment in patients undergoing neoadjuvant therapy for breast cancer. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
|Study Start Date:||August 2008|
|Estimated Study Completion Date:||December 2015|
|Estimated Primary Completion Date:||December 2014 (Final data collection date for primary outcome measure)|
Experimental: Optical Imaging
Tomographic Optical Imaging Arm
Device: Near-Infrared Tomographic Optical Breast Imaging
TOBI scan performed before the participant starts cancer treatment and at the start of each treatment cycle
Other Name: TOBI
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT00783757
|United States, Massachusetts|
|Massachusetts General Hospital|
|Boston, Massachusetts, United States, 02114|
|Principal Investigator:||Steven Isakoff, MD, PhD||Massachusetts General Hospital|