Tissue Oxygenation Measurements With Modulated Light (S-FLARE)

NCT01116297 | Completed Phase 1

• 1 other identifier: 2009-P000384 BIDMC
• Study Type: interventional
• Target: 4
• Locations: 1 country
• Sites: 1

Brief Summary

To perform a pilot study of the S-FLARE imaging system, which uses low levels of safe, invisible, near-infrared light to measure tissue oxygenation during breast reconstructive surgery and to compare S-FLARE measurements to the gold standard, FDA-approved, the ViOptix optical probe.

Conditions

Breast Cancer

Keywords

breast reconstruction; breast cancer; near infrared imaging

Outcome Measures

Primary Outcomes (1)

• Optimization of Ergonomics and Functioning of the S-FLARE Imaging System during Breast Reconstructive Surgery

  Due to patient-to-patient anatomic variation, the vascular perfusion to the skin in DIEP flaps is unpredictable and of great concern to the surgeon planning the flap design. We propose a method of imaging tissue oxygenation within a DIEP flap base on the use of invisible near-infrared light. This pilot study is a comparison study of oxygenation measurements taken by the ViOptix optical probe as the standard of care and the S-FLARE imaging system, with the intention of optimizing the ergonomics and functionality of the S-FLARE imaging system for use during breast reconstructive surgery.

  10 minute imaging procedure

Study Arms (1)

Imaging with S-FLARE imaging system

EXPERIMENTAL

3 patients to be imaged by S-FLARE imaging system.

Device: Imaging with S-FLARE imaging system

Interventions

Imaging with S-FLARE imaging system DEVICE

Tissue oxygenation measurements during plastic surgery using the S-FLARE system.

Imaging with S-FLARE imaging system

Eligibility Criteria

• Age: 21 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women or men above the age of 21 who are undergoing unilateral breast reconstruction after mastectomy.
• Women of childbearing age must have a negative pregnancy test as confirmed by anesthesiologist.

You may not qualify if:

• BMI \> 30.

Sponsors & Collaborators

• Beth Israel Deaconess Medical Center: lead

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Links

• Website of the study principal investigator with detailed information about related work.

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Diagnostic Imaging

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• John V. Frangioni, MD, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: February 3, 2010
• First Posted: May 4, 2010
• Study Start: January 1, 2010
• Primary Completion: February 1, 2013
• Study Completion: February 1, 2013
• Last Updated: February 18, 2013

Record last verified: 2013-02

Locations

US (1)