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TOBI to Monitor Response to Neoadjuvant Therapy in Breast Cancer

This study is currently recruiting participants.
Verified April 2013 by Massachusetts General Hospital
Sponsor:
Information provided by (Responsible Party):
Steven Isakoff, MD, PhD, Massachusetts General Hospital
ClinicalTrials.gov Identifier:
NCT00783757
First received: October 30, 2008
Last updated: April 29, 2013
Last verified: April 2013
History of Changes
  Purpose

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 Intervention
Breast Cancer
 Device: Near-Infrared Tomographic Optical Breast Imaging

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
Official Title: Functional Metabolic Near-infrared Tomographic Optical Breast Imaging (TOBI) to Monitor Response to Neoadjuvant Therapy in Breast Cancer

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Massachusetts General Hospital:

Primary Outcome Measures:
  • To explore the feasibility of measuring optically derived parameters in the clinical setting. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

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. [ Time Frame: 4 years ] [ Designated as safety issue: No ]
  • To evaluate changes in optical imaging-derived deoxyhemoglobin concentration early in treatment in patients undergoing neoadjuvant therapy for breast cancer. [ Time Frame: 4 years ] [ Designated as safety issue: No ]

Estimated Enrollment: 24
Study Start Date: August 2008
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Optical Imaging
Tomographic Optical Imaging Arm
 Device: Near-Infrared Tomographic Optical Breast Imaging
TOBI scan performed before the participant starts cancer treatment and at the start of each treatment cycle
Other Name: TOBI

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.
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00783757

Contacts
Contact: Steven Isakoff, MD, PhD 617-726-6500
Contact: Cory Ferguson 617-724-5496

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Steven J isakoff, MD, PhD     617-726-6500        
Contact: Nancy Nagda     617 726 6500        
Sponsors and Collaborators
Steven Isakoff, MD, PhD
Investigators
Principal Investigator: Steven Isakoff, MD, PhD Massachusetts General Hospital
  More Information

No publications provided

Responsible Party: Steven Isakoff, MD, PhD, Attending Physician, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT00783757     History of Changes
Other Study ID Numbers: 07-305
Study First Received: October 30, 2008
Last Updated: April 29, 2013
Health Authority: United States: Food and Drug Administration

Keywords provided by Massachusetts General Hospital:
neo-adjuvant chemotherapy
TOBI
breast imaging
optical imaging

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

ClinicalTrials.gov processed this record on May 23, 2013