NCT00546091

Brief Summary

This study will explore the uses of three noninvasive imaging techniques-thermography, laser Doppler imaging, and multispectral imaging-to test the blood flow of healthy volunteers. By comparing these three techniques, researchers will be able to train these imaging systems to better evaluate skin types and blood flow. The study will also test computer programs that have been developed to correct for the effects of curvature and body hair on the images. Healthy volunteers must be older than 18 years of age and may not have had a history of malignant tumors, skin disease, or vascular disease. Participants will undergo the following procedures on an outpatient basis: Three different types of images taken of the participant s forearm

  • Thermography infrared thermal imaging to map skin temperature
  • Laser Doppler imaging low-powered laser imaging to map blood flow in the skin
  • Multispectral imaging near-infrared light imaging to measure total blood flow and oxygen levels in the skin A reactive hyperemia experiment, in which multispectral images will be taken of the participant s forearm during and after the use of a blood pressure cuff A hair removal experiment, in which images will be collected of the participant s forearm in separate scans done before and after the hair is removed with a topical hair removal solution The entire series of exams will take approximately one hour to perform.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
15

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2007

Longer than P75 for all trials

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

October 15, 2007

Completed
2 days until next milestone

First Submitted

Initial submission to the registry

October 17, 2007

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 18, 2007

Completed
5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 19, 2012

Completed
Last Updated

October 6, 2017

Status Verified

October 19, 2012

First QC Date

October 17, 2007

Last Update Submit

October 5, 2017

Conditions

Keywords

ImagingMulti-Spectral ImagingThermographyLaser Doppler ImagingVasculatureHealthy VolunteerHV

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age 18 years or greater.

You may not qualify if:

  • Healthy volunteers with any skin disease.
  • Past or present history of malignant tumors.
  • Past or present hematologic abnormality of Hgb less than 9.0 gm/dl.
  • Healthy volunteers with any past or present vein disease.
  • Unable or unwilling to give informed consent.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

National Institutes of Health Clinical Center, 9000 Rockville Pike

Bethesda, Maryland, 20892, United States

Location

Related Publications (3)

  • Thorniley MS, Sinclair JS, Barnett NJ, Shurey CB, Green CJ. The use of near-infrared spectroscopy for assessing flap viability during reconstructive surgery. Br J Plast Surg. 1998 Apr;51(3):218-26. doi: 10.1054/bjps.1997.0145.

    PMID: 9664881BACKGROUND
  • Wolf M, Weber O, Keel M, Golay X, Scheidegger M, Bucher HU, Kollias S, Boesiger P, Banziger O. Comparison of cerebral blood volume measured by near infrared spectroscopy and contrast enhanced magnetic resonance imaging. Adv Exp Med Biol. 1999;471:767-73. doi: 10.1007/978-1-4615-4717-4_88.

    PMID: 10659212BACKGROUND
  • Essex TJ, Byrne PO. A laser Doppler scanner for imaging blood flow in skin. J Biomed Eng. 1991 May;13(3):189-94. doi: 10.1016/0141-5425(91)90125-q.

    PMID: 1870327BACKGROUND

Study Officials

  • Amir Gandjbakhche, Ph.D.

    Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Time Perspective
PROSPECTIVE
Sponsor Type
NIH

Study Record Dates

First Submitted

October 17, 2007

First Posted

October 18, 2007

Study Start

October 15, 2007

Study Completion

October 19, 2012

Last Updated

October 6, 2017

Record last verified: 2012-10-19

Locations