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NCT Number: NCT01484730

A Pilot Study to Evaluate Multi-Spectral and Laser Speckle Imaging and Multiphoton Microscopy During Vascular Occlusion

The purpose of this research is to evaluate and validate the performance of non-invasive imaging modalities for assessment of skin. A pressure cuff occlusion will be used to stimulate blood flow dynamic that these instruments are designed to sense. The researcher currently plan to assess only basic feasibility of the imaging instruments.

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Key information

Conditions

Abnormal Vascular Flow

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Beckman Laser Institute and Medical Clinic

Irvine, California, 92612, United States

Location status: Recruiting

Location contact

Anthony Durkin, PhD

CONTACT

[email protected]

949-824-3284

Bernard Choi, PhD

SUB_INVESTIGATOR

Kristen Kelly, MD

SUB_INVESTIGATOR

About this study

The primary reason for including pressure cuff occlusion in this protocol is to test the performance of Multi-Spectral Imaging and Laser Speckle Imaging can measure in the full range of vascular conditions ranging from ischemic (under-perfused or unsaturated) to hyperemic (over-perfused and over-saturated).

  • Modulated Imaging a non-contact optical imaging technology can detect the concentration of total hemoglobin, deoxygenated and oxygenated hemoglobin in absolute amounts in units of millimoles / unit volume of tissue measured.
  • Laser Speckle Imaging a non-contact optical imaging technology consists of a coherent light source, camera, and image acquisition system. This image device can measure and compare relative flow in vasculature at varied time points.

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • Male and female adult 18 years and older

Exclusion criteria

  • Younger than 18 years of age
  • Pregnant women

Treatment and study plan

Multi-Spectral and Laser Speckle Imaging

Device

Changes in skin tissue and blood flow.

Primary outcomes

  1. Skin blood flow

    Time frame: 4 weeks

    The key factor of interest is measuring the changes in the fluorescence signal of the epidermal cells during the arm occlusion, which will provide information about changes in cellular metabolism during cellular oxygen deprivation. Time series of optical sections (two-dimensional x-y images parallel to the skin surface of about 250x250 µm2) at the same depth will be obtained before, during and after the arm occlusion. The images will be based on two-photon excitation of endogenous fluorophores (NADH). To quantify the fluorescence signal, which will provide information about changes of cellular metabolism, we will use the integrated brightness of each image (same rectangular area for all images) as a measure of the signal. The integrated brightness is defined as the sum of pixels weighted over the brightness values (or gray values) of the pixel. A statistical plan is not appropriate at this stage of the pilot study.

Study contacts

Contact information is provided by the study sponsor or research team.

Gordon Kennedy, PhD

CONTACT

[email protected]

949-824-4713

Sponsors and collaborators

Lead sponsor

University of California, Irvine

Other

Collaborators

  • United States Department of Defense

Registry information

Official study title

A Pilot Study to Evaluate Multi-Spectral Imaging (MI) and Laser Speckle Imaging (LSI) and Multiphoton Microscopy (MPM) During Vascular Occlusion

Important dates

Study start
2011
Primary completion
2026
Study completion
2028
First posted
Dec 2, 2011
Registry last updated
Dec 10, 2025

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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