Back to resultsNon Invasive Optical Imaging of WBC Count
Primary Purpose
Hematologic Malignancy
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
AM4113-N5UT Dino-Lite
Sponsored by
About this trial
This is an interventional device feasibility trial for Hematologic Malignancy focused on measuring Hematologic malignancy
Eligibility Criteria
Inclusion Criteria:
- Patients with lymphoid malignancies or plasma cell dyscrasias who are admitted to the Massachusetts General Hospital to undergo autologous stem cell transplantation or are seen in the outpatient clinic
- Age ≥ 18 years
- Ability to understand and the willingness to sign a written informed consent document.
- Patients must have WBC ≥ 3000 / µl and ANC ≥ 1500 / µl at admission or their last clinical visit to be enrolled.
Exclusion Criteria:
- History of allergic reactions attributed to compounds of similar chemical or biologic composition of baby oil.
- Myelodysplasia
- Skin phototype < 4 in the Fitzpatrick scale.
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Non-Invasive Imaging
Arm Description
Commercial portable optical microscope (AM4113-N5UT Dino-Lite ) which will be employed during the study for a pre determined time of non-invasive imaging of the nailfold capillaries in ASCT patients. For Autologous Stem Cell Transplant (ASCT) participants, the imaging will be performed once prior to ASCT upon admission to the hospital, and then daily after ASCT (starting on day +7) until count recovery
Outcomes
Primary Outcome Measures
Video of nail-fold imaging captured by capillaroscope
Image acquisition from device to then analyze and compare with complete blood counts measured in a standard fashion
Secondary Outcome Measures
Full Information
NCT ID
NCT02512666
First Posted
July 28, 2015
Last Updated
June 7, 2018
Sponsor
Massachusetts General Hospital
1. Study Identification
Unique Protocol Identification Number
NCT02512666
Brief Title
Non Invasive Optical Imaging of WBC Count
Official Title
Non Invasive Optical Imaging of Capillaries Through the Nailfold for White Blood Cell Enumeration in Patients With Hematologic Malignancies
Study Type
Interventional
2. Study Status
Record Verification Date
June 2018
Overall Recruitment Status
Completed
Study Start Date
September 2015 (undefined)
Primary Completion Date
September 2017 (Actual)
Study Completion Date
September 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This research study is looking at a small device that measures white blood cell (WBC) counts by being placed against the finger nail for participants who are undergoing stem cell transplantation at Massachusetts General Hospital or have a hematologic malignancy and are being seen as an outpatient.
Detailed Description
The objective of this study is to obtain data that would support the use of a method to obtain WBC counts from images of small blood vessels called capillaries. These would be obtained by pressing a small device on the surface of participants' finger nails to look through the nail. These images will be obtained using a portable microscope called the Dino-Lite Digital Microscope.
Having a non-invasive way to quickly measure WBC counts could be useful for a variety of healthcare applications.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Hematologic Malignancy
Keywords
Hematologic malignancy
7. Study Design
Primary Purpose
Device Feasibility
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
45 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Non-Invasive Imaging
Arm Type
Experimental
Arm Description
Commercial portable optical microscope (AM4113-N5UT Dino-Lite ) which will be employed during the study for a pre determined time of non-invasive imaging of the nailfold capillaries in ASCT patients.
For Autologous Stem Cell Transplant (ASCT) participants, the imaging will be performed once prior to ASCT upon admission to the hospital, and then daily after ASCT (starting on day +7) until count recovery
Intervention Type
Device
Intervention Name(s)
AM4113-N5UT Dino-Lite
Primary Outcome Measure Information:
Title
Video of nail-fold imaging captured by capillaroscope
Description
Image acquisition from device to then analyze and compare with complete blood counts measured in a standard fashion
Time Frame
4 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with lymphoid malignancies or plasma cell dyscrasias who are admitted to the Massachusetts General Hospital to undergo autologous stem cell transplantation or are seen in the outpatient clinic
Age ≥ 18 years
Ability to understand and the willingness to sign a written informed consent document.
Patients must have WBC ≥ 3000 / µl and ANC ≥ 1500 / µl at admission or their last clinical visit to be enrolled.
Exclusion Criteria:
History of allergic reactions attributed to compounds of similar chemical or biologic composition of baby oil.
Myelodysplasia
Skin phototype < 4 in the Fitzpatrick scale.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Yi-Bin A Chen, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02115
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
IPD Sharing Plan Description
No plan to share data
Learn more about this trial
Non Invasive Optical Imaging of WBC Count
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