NCT00952107

Brief Summary

The main purpose of this study is to test the ergonomics of an investigational imaging system that can take pictures of blood vessels under the skin. In plastic and reconstructive surgery, blood flow to tissue determines whether the tissue can be transplanted from one location to another. This new imaging device uses invisible near-infrared fluorescent light to see blood vessels that otherwise could not be seen by eye. This study will test the system's basic operation and ergonomics in the operating room.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
6

participants targeted

Target at below P25 for early_phase_1 cancer

Timeline
Completed

Started Jun 2009

Typical duration for early_phase_1 cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2009

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 31, 2009

Completed
4 days until next milestone

First Posted

Study publicly available on registry

August 4, 2009

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2012

Completed
Last Updated

June 13, 2012

Status Verified

June 1, 2012

Enrollment Period

2.7 years

First QC Date

July 31, 2009

Last Update Submit

June 11, 2012

Conditions

Cancer

Keywords

breast cancerbreast reconstructive surgeryflap assessment

Outcome Measures

Primary Outcomes (1)

  • System operation

    2 minutes

Study Arms (1)

Imaging system operation

EXPERIMENTAL
Device: FLARE imaging system

Interventions

FLARE imaging systemDEVICE

Testing of operation of imaging system

Imaging system operation

Eligibility Criteria

Age21 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (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:

  • Patients with a known or suspected iodide or seafood allergy.
  • Patients with known renal, cardiac, hepatic, or pulmonary disease.
  • BMI \> 30

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Beth Israel Deaconess Medical Center

Boston, Massachusetts, 02215, United States

Location

Related Publications (1)

  • Lee BT, Hutteman M, Gioux S, Stockdale A, Lin SJ, Ngo LH, Frangioni JV. The FLARE intraoperative near-infrared fluorescence imaging system: a first-in-human clinical trial in perforator flap breast reconstruction. Plast Reconstr Surg. 2010 Nov;126(5):1472-1481. doi: 10.1097/PRS.0b013e3181f059c7.

    PMID: 21042103DERIVED

Related Links

MeSH Terms

Conditions

NeoplasmsBreast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • John V Frangioni, MD, PhD

    Beth Israel Deaconess Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

First Submitted

July 31, 2009

First Posted

August 4, 2009

Study Start

June 1, 2009

Primary Completion

February 1, 2012

Study Completion

February 1, 2012

Last Updated

June 13, 2012

Record last verified: 2012-06

Locations

US(1)