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The purpose of this study is see fi the hyperspectral camera system (HCS) can measure skin blood flow (perfusion and oxygenation) in healthy people.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Healthy Volunteer | Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Quest Hyperspectral Imaging System | Diagnostic Test | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Up to 6 months |
| Mean Cutaneous Tissue Oxygen Saturation/StO2 | Measure changes in blood flow when vessels constrict or dilate by mean measurements Cutaneous Tissue Oxygen Saturation/StO2 | Up to 6 months |
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Inclusion Criteria:
Exclusion Criteria:
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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.
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| Name | Affiliation | Role |
|---|---|---|
| Michelle Bradbury, MD, PhD | Memorial Sloan Kettering Cancer Center | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Memorial Sloan Kettering Cancer Center | New York | New York | 10065 | United States |
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| Label | URL |
|---|---|
| Memorial Sloan Kettering Cancer Center | View source |
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• 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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | Posted | Count of Participants | Participants | Up to 6 months |
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Up to 6 months
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Michelle Bradbury, MD, PhD | Memorial Sloan Kettering Cancer Center | 917-294-4585 | bradburm@MSKCC.ORG |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 8, 2024 | Sep 15, 2025 | Prot_SAP_001.pdf |
| ICF | No | No | Yes | Informed Consent Form | Aug 20, 2019 | Jun 10, 2020 | ICF_000.pdf |
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|
| years |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Race (NIH/OMB) | Count of Participants | Participants |
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| Region of Enrollment | Count of Participants | Participants |
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| Units |
|---|
| Counts |
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| Participants |
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| 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 | Posted | Median | Standard Deviation | percentage of StO2 | Up to 6 months |
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| 0 |
| 8 |
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| 8 |
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| 8 |
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| Title | Measurements |
|---|---|
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