Clinical trial NCT03912376: A Study of a Device Used to Take Pictures of Skin Blood Flow
Official title: Feasibility Study of a Hyperspectral Imaging System in Detection of Human Skin Perfusion and Oxygenation
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Basal Blood Flow
Keywords: Blood Flow
Healthy Participant
Memorial Sloan Kettering Cancer Center
19-098
Lead sponsor: Memorial Sloan Kettering Cancer Center
Sponsor class: OTHER
First posted: 2019-04-11
Enrollment: 8
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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.

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


Eligibility criteria: 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.

Primary outcomes:
measure: Reproduce camera wavelengths needed to reproducibly measure blood flow and oxygenation in the brachial artery of normal human subjects
timeFrame: Up to 6 months
measure: Measure changes in blood flow when vessels constrict or dilate
timeFrame: Up to 6 months
Secondary outcomes:
Other outcomes:
Locations:
city: New York
country: United States
facility: Memorial Sloan Kettering Cancer Center
state: New York
Study officials:
affiliation: Memorial Sloan Kettering Cancer Center
name: Michelle Bradbury, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References: