Basal Blood FlowNCT03912376
A Study of a Device Used to Take Pictures of Skin Blood Flow
An observational study of Basal Blood Flow, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Basal Blood Flow
- What is being tested?
- Quest Hyperspectral Imaging System
- How many people
- 8 participants
- Where
- 1 siteUnited States
- Study dates
- 5 Apr 2019to 23 Sep 2024
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
United States1 site
Memorial Sloan Kettering Cancer Center
New York, New York, 10065
About this study
Official title: 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.
- Conditions
- Basal Blood Flow
- Being tested
- Quest Hyperspectral Imaging System
- Keywords
- Blood Flow, Healthy Participant, Memorial Sloan Kettering Cancer Center, 19-098
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Quest Hyperspectral Imaging SystemDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Healthy Volunteer | Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history. Receives: Diagnostic Test: Quest Hyperspectral Imaging System |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
Measured: Up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Apr 2019
- Study start5 Apr 2019
- Primary completion23 Sep 2024
- Study completion23 Sep 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Basal Blood FlowStudies of the same condition, open and under way.
- More trials run by Memorial Sloan Kettering Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Memorial Sloan Kettering Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Michelle Bradbury, MD, PhD, Principal investigator, Memorial Sloan Kettering Cancer Center
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03912376
- Sponsor's protocol ID
- 19-098
- Status last verified
- Sep 2024
- First submitted
- 8 Apr 2019
- Last updated
- 15 Dec 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: • 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.
Study at a glance
From the registry record, last updated by the sponsor on 15 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Feasibility Study of a Hyperspectral Imaging System in Detection of Human Skin Perfusion and Oxygenation
- ClinicalTrials.gov ID
- NCT03912376
- Acronym / sponsor ID
- 19-098
- Conditions
- Basal Blood Flow
- Keywords
- Blood Flow, Healthy Participant, Memorial Sloan Kettering Cancer Center, 19-098
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Memorial Sloan Kettering Cancer CenterUniversity, hospital or other
- Study start
- 5 Apr 2019 (actual)
- Primary completion
- 23 Sep 2024 (actual)
- Study completion
- 23 Sep 2024 (actual)
- First posted
- 11 Apr 2019 (actual)
- Results
- Posted 15 Dec 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy Volunteer | – | Diagnostic Test: Quest Hyperspectral Imaging SystemHealthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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:
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Quest Hyperspectral Imaging SystemIn 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. | Diagnostic test | Healthy Volunteer |
Primary outcome
Number of Participants Evaluated to Measure Blood Flow and Oxygenation in the Brachial Artery
Time frame: Up to 6 months
Number of participants evaluated to measure blood flow and oxygenation in the brachial artery
Mean Cutaneous Tissue Oxygen Saturation/StO2
Time frame: Up to 6 months
Measure changes in blood flow when vessels constrict or dilate by mean measurements Cutaneous Tissue Oxygen Saturation/StO2
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Dec 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Memorial Sloan Kettering Cancer CenterLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. • 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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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michelle Bradbury, MD, PhD principal investigator
Memorial Sloan Kettering Cancer Center
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Basal Blood Flow, run by Memorial Sloan Kettering Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 15 Dec 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of Participants Evaluated to Measure Blood Flow and Oxygenation in the Brachial Artery (time frame: Up to 6 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Dec 2025.