Basal Blood Flow
Conditions
Keywords
Blood Flow, Healthy Participant, Memorial Sloan Kettering Cancer Center, 19-098
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.
Interventions
DIAGNOSTIC_TESTQuest 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.
Sponsors
Memorial Sloan Kettering Cancer Center
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 45 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants Evaluated to Measure Blood Flow and Oxygenation in the Brachial Artery | Up to 6 months | Number of participants evaluated to measure blood flow and oxygenation in the brachial artery |
| Mean Cutaneous Tissue Oxygen Saturation/StO2 | Up to 6 months | Measure changes in blood flow when vessels constrict or dilate by mean measurements Cutaneous Tissue Oxygen Saturation/StO2 |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Healthy Volunteer Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history.
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. | 8 |
| Total | 8 |
Baseline characteristics
| Characteristic | Healthy Volunteer |
|---|---|
| Age, Continuous | 23.5 years |
| Ethnicity (NIH/OMB) Hispanic or Latino | 0 Participants |
| Ethnicity (NIH/OMB) Not Hispanic or Latino | 8 Participants |
| Ethnicity (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) American Indian or Alaska Native | 0 Participants |
| Race (NIH/OMB) Asian | 0 Participants |
| Race (NIH/OMB) Black or African American | 0 Participants |
| Race (NIH/OMB) More than one race | 0 Participants |
| Race (NIH/OMB) Native Hawaiian or Other Pacific Islander | 0 Participants |
| Race (NIH/OMB) Unknown or Not Reported | 0 Participants |
| Race (NIH/OMB) White | 8 Participants |
| Region of Enrollment United States | 8 Participants |
| Sex: Female, Male Female | 6 Participants |
| Sex: Female, Male Male | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 8 |
| other Total, other adverse events | 0 / 8 |
| serious Total, serious adverse events | 0 / 8 |
Outcome results
Primary
Mean Cutaneous Tissue Oxygen Saturation/StO2
Measure changes in blood flow when vessels constrict or dilate by mean measurements Cutaneous Tissue Oxygen Saturation/StO2
Time frame: Up to 6 months
| Arm | Measure | Group | Value (MEDIAN) | Dispersion |
|---|---|---|---|---|
| Healthy Volunteer | Mean Cutaneous Tissue Oxygen Saturation/StO2 | Maximum occlusion | 72.3 percentage of StO2 | Standard Deviation 15.9 |
| Healthy Volunteer | Mean Cutaneous Tissue Oxygen Saturation/StO2 | Basal Phase | 86.6 percentage of StO2 | Standard Deviation 10 |
| Healthy Volunteer | Mean Cutaneous Tissue Oxygen Saturation/StO2 | Reperfusion | 85.5 percentage of StO2 | Standard Deviation 9.9 |
Primary
Number of Participants Evaluated to Measure Blood Flow and Oxygenation in the Brachial Artery
Number of participants evaluated to measure blood flow and oxygenation in the brachial artery
Time frame: Up to 6 months
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Healthy Volunteer | Number of Participants Evaluated to Measure Blood Flow and Oxygenation in the Brachial Artery | 8 Participants |