Back to resultsTOBI to Monitor Response to Neoadjuvant Therapy in Breast Cancer
Primary Purpose
Breast Cancer
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Optical Imaging
Sponsored by
About this trial
This is an interventional device feasibility trial for Breast Cancer focused on measuring neo-adjuvant chemotherapy, TOBI, breast imaging, optical imaging
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
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Optical Imaging
Arm Description
Tomographic Optical Imaging Arm
Outcomes
Primary Outcome Measures
To explore the feasibility of measuring optically derived parameters in the clinical setting.
Secondary Outcome Measures
To explore the changes before and after neoadjuvant therapy of additional parameters derived from dynamic and static optical imaging of primary breast cancer.
To evaluate changes in optical imaging-derived deoxyhemoglobin concentration early in treatment in patients undergoing neoadjuvant therapy for breast cancer.
Full Information
NCT ID
NCT00783757
First Posted
October 30, 2008
Last Updated
July 25, 2017
Sponsor
Steven Isakoff, MD, PhD
1. Study Identification
Unique Protocol Identification Number
NCT00783757
Brief Title
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
2. Study Status
Record Verification Date
July 2017
Overall Recruitment Status
Completed
Study Start Date
August 2008 (undefined)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
June 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Steven Isakoff, MD, PhD
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
neo-adjuvant chemotherapy, TOBI, breast imaging, optical imaging
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Optical Imaging
Arm Type
Experimental
Arm Description
Tomographic Optical Imaging Arm
Intervention Type
Device
Intervention Name(s)
Optical Imaging
Other Intervention Name(s)
TOBI
Intervention Description
TOBI scan performed before the participant starts cancer treatment and at the start of each treatment cycle
Primary Outcome Measure Information:
Title
To explore the feasibility of measuring optically derived parameters in the clinical setting.
Time Frame
4 years
Secondary Outcome Measure Information:
Title
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
Title
To evaluate changes in optical imaging-derived deoxyhemoglobin concentration early in treatment in patients undergoing neoadjuvant therapy for breast cancer.
Time Frame
4 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Steven Isakoff, MD, PhD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
TOBI to Monitor Response to Neoadjuvant Therapy in Breast Cancer
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