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

Memorial Sloan Kettering Cancer Center1 site in 1 country8 target enrollmentApril 5, 2019

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Basal Blood Flow
Sponsor: Memorial Sloan Kettering Cancer Center
Enrollment: 8
Locations: 1
Primary Endpoint: Number of Participants Evaluated to Measure Blood Flow and Oxygenation in the Brachial Artery
Status: Completed
Last Updated: 4 months ago

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

Registry

clinicaltrials.gov

Start Date

April 5, 2019

End Date

September 23, 2024

Last Updated

4 months ago

Study Type

Observational

Sex

All

Sponsor

Responsible Party

Sponsor

•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.

•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.