TOBI to Monitor Response to Neoadjuvant Therapy in Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00783757
Recruitment Status : Completed
First Posted : November 3, 2008
Last Update Posted : July 27, 2017
Information provided by (Responsible Party):
Steven Isakoff, MD, PhD, Massachusetts General Hospital

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Device: Optical Imaging Not Applicable

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: Functional Metabolic Near-infrared Tomographic Optical Breast Imaging (TOBI) to Monitor Response to Neoadjuvant Therapy in Breast Cancer
Study Start Date : August 2008
Actual Primary Completion Date : December 2014
Actual Study Completion Date : June 2017

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
Experimental: Optical Imaging
Tomographic Optical Imaging Arm
Device: Optical Imaging
TOBI scan performed before the participant starts cancer treatment and at the start of each treatment cycle
Other Name: TOBI

Primary Outcome Measures :
  1. To explore the feasibility of measuring optically derived parameters in the clinical setting. [ Time Frame: 4 years ]

Secondary Outcome Measures :
  1. 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 ]
  2. To evaluate changes in optical imaging-derived deoxyhemoglobin concentration early in treatment in patients undergoing neoadjuvant therapy for breast cancer. [ Time Frame: 4 years ]

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00783757

United States, Massachusetts
Massachusetts General Hospital
Boston, Massachusetts, United States, 02114
Sponsors and Collaborators
Steven Isakoff, MD, PhD
Principal Investigator: Steven Isakoff, MD, PhD Massachusetts General Hospital

Responsible Party: Steven Isakoff, MD, PhD, Attending Physician, Massachusetts General Hospital Identifier: NCT00783757     History of Changes
Other Study ID Numbers: 07-305
First Posted: November 3, 2008    Key Record Dates
Last Update Posted: July 27, 2017
Last Verified: July 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Keywords provided by Steven Isakoff, MD, PhD, Massachusetts General Hospital:
neo-adjuvant chemotherapy
breast imaging
optical imaging

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases