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


N/A
18 Years
N/A
Open (Enrolling)
Female
Breast Cancer

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Trial Information

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


- 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.


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

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Outcome Measure:

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

Outcome Time Frame:

4 years

Safety Issue:

No

Principal Investigator

Steven Isakoff, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Massachusetts General Hospital

Authority:

United States: Food and Drug Administration

Study ID:

07-305

NCT ID:

NCT00783757

Start Date:

August 2008

Completion Date:

December 2014

Related Keywords:

  • Breast Cancer
  • neo-adjuvant chemotherapy
  • TOBI
  • breast imaging
  • optical imaging
  • Breast Neoplasms

Name

Location

Massachusetts General HospitalBoston, Massachusetts  02114-2617