Clinical trial NCT00783757: TOBI to Monitor Response to Neoadjuvant Therapy in Breast Cancer
Official title: Functional Metabolic Near-infrared Tomographic Optical Breast Imaging (TOBI) to Monitor Response to Neoadjuvant Therapy in Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Breast Cancer
Keywords: neo-adjuvant chemotherapy
TOBI
breast imaging
optical imaging
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
First posted: 2008-11-02
Enrollment: 30
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DEVICE_FEASIBILITY

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.

Eligibility criteria: 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

Primary outcomes:
measure: To explore the feasibility of measuring optically derived parameters in the clinical setting.
timeFrame: 4 years
Secondary outcomes:
measure: To explore the changes before and after neoadjuvant therapy of additional parameters derived from dynamic and static optical imaging of primary breast cancer.
timeFrame: 4 years
measure: To evaluate changes in optical imaging-derived deoxyhemoglobin concentration early in treatment in patients undergoing neoadjuvant therapy for breast cancer.
timeFrame: 4 years
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Steven Isakoff, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: