TOBI to Monitor Response to Neoadjuvant Therapy in Breast Cancer

July 25, 2017 updated by: Steven Isakoff, MD, PhD

Functional Metabolic Near-infrared Tomographic Optical Breast Imaging (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 Overview

Status

Completed

Conditions

Intervention / Treatment

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

Enrollment (Actual)

30

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Massachusetts
      • Boston, Massachusetts, United States, 02114
        • Massachusetts General Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Device Feasibility
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / 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 Names:
  • TOBI

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
To explore the feasibility of measuring optically derived parameters in the clinical setting.
Time Frame: 4 years
4 years

Secondary Outcome Measures

Outcome Measure
Time Frame
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
4 years
To evaluate changes in optical imaging-derived deoxyhemoglobin concentration early in treatment in patients undergoing neoadjuvant therapy for breast cancer.
Time Frame: 4 years
4 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Steven Isakoff, MD, PhD

Investigators

  • Principal Investigator: Steven Isakoff, MD, PhD, Massachusetts General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2008

Primary Completion (Actual)

December 1, 2014

Study Completion (Actual)

June 1, 2017

Study Registration Dates

First Submitted

October 30, 2008

First Submitted That Met QC Criteria

October 30, 2008

First Posted (Estimate)

November 2, 2008

Study Record Updates

Last Update Posted (Actual)

July 27, 2017

Last Update Submitted That Met QC Criteria

July 25, 2017

Last Verified

July 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 07-305

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Subscribe