A Study of a Device Used to Take Pictures of Skin Blood Flow

Feasibility Study of a Hyperspectral Imaging System in Detection of Human Skin Perfusion and Oxygenation

The purpose of this study is see fi the hyperspectral camera system (HCS) can measure skin blood flow (perfusion and oxygenation) in healthy people.

Study Overview

• Status: Active, not recruiting
• Conditions: Basal Blood Flow
• Intervention / Treatment: Diagnostic test: Quest Hyperspectral Imaging System

• Study Type: Observational
• Enrollment (Actual): 8

Contacts and Locations

Study Locations

• United States
  • New York
    • New York, New York, United States, 10065
      • Memorial Sloan Kettering Cancer Center

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 45 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Enrollment in this study will be open to all Memorial Sloan Kettering employees to act as healthy volunteers provided they meet eligibility criteria. Every effort will be made to include women and minorities in the research study. Employees who provide consent willfully and voluntarily may participate as a healthy volunteer once.

Description

Inclusion Criteria:

• Healthy volunteers, 18 to 45 years of age, inclusive. Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history.
• Body mass index (BMI) between 18 to 30 kg/m2, inclusive, and with a minimum weight of 50 kg.
• Able to participate and willing to give written informed consent and to comply with the study restrictions.

Exclusion Criteria:

• History or symptoms of any significant disease including (but not limited to), neurological, psychiatric, endocrine, cardiovascular, respiratory, gastrointestinal, hepatic, or renal disorder.
• Systolic blood pressure (SBP) greater than 140 or less than 90 mm Hg, and diastolic blood pressure (DBP) greater than 90 or less than 50 mm Hg.
• Use of any medications (prescription or over-the-counter [OTC]), vitamin, mineral, herbal, and dietary supplements within 21 days of study drug administration, or less than 5 half-lives (whichever is longer). Exceptions are paracetamol (up to 4 g/day). Other exceptions will only be made if the rationale is discussed and clearly documented between the Investigator and the sponsor.
• Concomitant disease or condition that could interfere with, or for which the treatment of might interfere with, the conduct of the study, or that would, in the opinion of the Investigator, pose an unacceptable risk to the subject in this study.
• Smokers as defined by any of the following criteria:
• Reported smoking of cigarettes within 12 months prior to screening; occasionally a cigarette is allowed, but not within 24 hours of the measurement.
• Any confirmed significant allergic reactions (urticarial or anaphylaxis) against any drug, or multiple drug allergies (non-active hay fever is acceptable).
• Unwillingness of inability to comply with the study protocol for any other reason.

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Healthy Volunteer; Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history.	Diagnostic test: Quest Hyperspectral Imaging System; In this camera 3 sensors are combined for optimal spectral imaging. For 2D reference, and to facilitate annotating the data, a high resolution (full HD) color image, recorded with an RGB-sensor, is included with each hyperspectral dataset.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Reproduce camera wavelengths needed to reproducibly measure blood flow and oxygenation in the brachial artery of normal human subjects	Up to 6 months
Measure changes in blood flow when vessels constrict or dilate	Up to 6 months

Collaborators and Investigators

• Sponsor: Memorial Sloan Kettering Cancer Center
• Investigators: Principal Investigator: Michelle Bradbury, MD, PhD, Memorial Sloan Kettering Cancer Center

Publications and helpful links

Helpful Links

• Memorial Sloan Kettering Cancer Center

Study record dates

Study Major Dates

• Study Start (Actual): April 5, 2019
• Primary Completion (Estimated): April 1, 2024
• Study Completion (Estimated): April 1, 2024

Study Registration Dates

• First Submitted: April 8, 2019
• First Submitted That Met QC Criteria: April 10, 2019
• First Posted (Actual): April 11, 2019

Study Record Updates

• Last Update Posted (Actual): August 29, 2023
• Last Update Submitted That Met QC Criteria: August 25, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Memorial Sloan Kettering Cancer Center; Blood Flow; Healthy Participant; 19-098
• Other Study ID Numbers: 19-098

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: YES
• IPD Plan Description: • Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on clinicaltrials.gov when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to: crdatashare@mskcc.org.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No