TOBI to Monitor Response to Neoadjuvant Therapy in Breast Cancer

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00783757
• Other study ID #: 07-305
• Status: Completed
• Phase: N/A
• First received: October 30, 2008
• Last updated: July 25, 2017
• Start date: August 2008
• Est. completion date: June 2017

Study information

• Verified date: July 2017
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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 information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: June 2017
• Est. primary completion date: December 2014
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Optical Imaging
TOBI scan performed before the participant starts cancer treatment and at the start of each treatment cycle

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Steven Isakoff, MD, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To explore the feasibility of measuring optically derived parameters in the clinical setting.		4 years
Secondary	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
Secondary	To evaluate changes in optical imaging-derived deoxyhemoglobin concentration early in treatment in patients undergoing neoadjuvant therapy for breast cancer.		4 years