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A Study of a Device Used to Take Pictures of Skin Blood Flow

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03912376
Recruitment Status : Active, not recruiting
First Posted : April 11, 2019
Last Update Posted : May 5, 2021
Sponsor:
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date April 8, 2019
First Posted Date April 11, 2019
Last Update Posted Date May 5, 2021
Actual Study Start Date April 5, 2019
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: April 10, 2019)
  • Reproduce camera wavelengths needed to reproducibly measure blood flow and oxygenation in the brachial artery of normal human subjects [ Time Frame: Up to 6 months ]
  • Measure changes in blood flow when vessels constrict or dilate [ Time Frame: Up to 6 months ]
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title 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
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.
Detailed Description Not Provided
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Basal Blood Flow
Intervention Diagnostic Test: 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.
Study Groups/Cohorts Healthy Volunteer
Healthy status is defined by absence of evidence of any active or chronic disease following a detailed medical and surgical history.
Intervention: Diagnostic Test: Quest Hyperspectral Imaging System
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Active, not recruiting
Actual Enrollment
 (submitted: April 10, 2019)
8
Original Estimated Enrollment Same as current
Estimated Study Completion Date April 2022
Estimated Primary Completion Date April 2022   (Final data collection date for primary outcome measure)
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.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 45 Years   (Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03912376
Other Study ID Numbers 19-098
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: Yes
Plan Description: • 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.
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor Memorial Sloan Kettering Cancer Center
Collaborators Not Provided
Investigators
Principal Investigator: Michelle Bradbury, MD, PhD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date April 2021