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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01484730
Enrollment
150
Registered
2011-12-02
Start date
2011-11-30
Completion date
2028-08-31
Last updated
2025-12-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Abnormal Vascular Flow

Brief summary

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.

Detailed description

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). 1. 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. 2. 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.

Interventions

DEVICEMulti-Spectral and Laser Speckle Imaging

Changes in skin tissue and blood flow.

Sponsors

United States Department of Defense
CollaboratorFED
University of California, Irvine
Lead SponsorOTHER

Study design

Observational model
CASE_ONLY
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

* Male and female adult 18 years and older

Exclusion criteria

* Younger than 18 years of age * Pregnant women

Design outcomes

Primary

MeasureTime frameDescription
Skin blood flow4 weeksThe 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.

Countries

United States

Contacts

Primary ContactGordon Kennedy, PhD
gordon.kennedy@uci.edu949-824-4713

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026