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OpenTrials
Completed

NCT Number: NCT00783757

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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

  • 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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Optical Imaging

Device

TOBI scan performed before the participant starts cancer treatment and at the start of each treatment cycle

Other names: TOBI

Primary outcomes

  1. To explore the feasibility of measuring optically derived parameters in the clinical setting.

    Time frame: 4 years

Secondary outcomes

  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

Sponsors and collaborators

Lead sponsor

Steven Isakoff, MD, PhD

Other

Registry information

Official study title

Functional Metabolic Near-infrared Tomographic Optical Breast Imaging (TOBI) to Monitor Response to Neoadjuvant Therapy in Breast Cancer

Important dates

Study start
2008
Primary completion
2014
Study completion
2017
First posted
Nov 3, 2008
Registry last updated
Jul 27, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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