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

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.

Study Overview

• Status: Recruiting
• Conditions: Abnormal Vascular Flow
• Intervention / Treatment: Device: Multi-Spectral and Laser Speckle Imaging

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.

• Study Type: Observational
• Enrollment (Estimated): 100

Contacts and Locations

• Study Contact: Name: Gordon Kennedy, PhD; Phone Number: 949-824-4713; Email: gordon.kennedy@uci.edu

Study Locations

• United States
  • California
    • Irvine, California, United States, 92612
      • Recruiting
      • Beckman Laser Institute and Medical Clinic
      • Sub-Investigator: Bernard Choi, PhD
      • Sub-Investigator: Kristen Kelly, MD
      • Contact: Anthony Durkin, PhD; Phone Number: 949-824-3284; Email: adurkin@hs.uci.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Study population will be selected from University of California Irvine, student and staff member.

Description

Inclusion Criteria:

• Male and female adult 18 years and older

Exclusion Criteria:

• Younger than 18 years of age
• Pregnant women

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Only
• Time Perspectives: Cross-Sectional

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Vascular Occlusion; Multi-Spectral and Laser Speckle Imaging	Device: Multi-Spectral and Laser Speckle Imaging; Changes in skin tissue and blood flow.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Skin blood flow	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.	4 weeks

Collaborators and Investigators

• Sponsor: University of California, Irvine
• Collaborators: United States Department of Defense
• Investigators: Principal Investigator: Anthony Durkin, PhD, University of California, Irvine

Study record dates

Study Major Dates

• Study Start: November 1, 2011
• Primary Completion (Estimated): August 1, 2026
• Study Completion (Estimated): August 1, 2026

Study Registration Dates

• First Submitted: November 29, 2011
• First Submitted That Met QC Criteria: December 1, 2011
• First Posted (Estimated): December 2, 2011

Study Record Updates

• Last Update Posted (Estimated): December 15, 2023
• Last Update Submitted That Met QC Criteria: December 8, 2023
• Last Verified: December 1, 2023

More Information

Terms related to this study

• Other Study ID Numbers: 20118370

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO