TOBI to Monitor Response to Neoadjuvant Therapy in Breast Cancer
Functional Metabolic Near-infrared Tomographic Optical Breast Imaging (TOBI) to Monitor Response to Neoadjuvant Therapy in Breast Cancer
1 other identifier
interventional
30
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Aug 2008
Longer than P75 for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
August 1, 2008
CompletedFirst Submitted
Initial submission to the registry
October 30, 2008
CompletedFirst Posted
Study publicly available on registry
November 3, 2008
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2014
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJuly 27, 2017
July 1, 2017
6.3 years
October 30, 2008
July 25, 2017
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To explore the feasibility of measuring optically derived parameters in the clinical setting.
4 years
Secondary Outcomes (2)
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
To evaluate changes in optical imaging-derived deoxyhemoglobin concentration early in treatment in patients undergoing neoadjuvant therapy for breast cancer.
4 years
Study Arms (1)
Optical Imaging
EXPERIMENTALTomographic Optical Imaging Arm
Interventions
TOBI scan performed before the participant starts cancer treatment and at the start of each treatment cycle
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Massachusetts General Hospital
Boston, Massachusetts, 02114, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Steven Isakoff, MD, PhD
Massachusetts General Hospital
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DEVICE FEASIBILITY
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Attending Physician
Study Record Dates
First Submitted
October 30, 2008
First Posted
November 3, 2008
Study Start
August 1, 2008
Primary Completion
December 1, 2014
Study Completion
June 1, 2017
Last Updated
July 27, 2017
Record last verified: 2017-07
Data Sharing
- IPD Sharing
- Will not share