Non Invasive Optical Imaging of WBC Count

Sponsor

Massachusetts General Hospital (Other)

Overall Status

Completed

CT.gov ID

NCT02512666

Collaborator

(none)

Enrollment

Location

Arm

Duration (Months)

1.9

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Hematologic Malignancy	Device: AM4113-N5UT Dino-Lite	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

45 participants

Allocation:

N/A

Intervention Model:

Single Group Assignment

Masking:

None (Open Label)

Primary Purpose:

Device Feasibility

Official Title:

Non Invasive Optical Imaging of Capillaries Through the Nailfold for White Blood Cell Enumeration in Patients With Hematologic Malignancies

Study Start Date :

Sep 1, 2015

Actual Primary Completion Date :

Sep 1, 2017

Actual Study Completion Date :

Sep 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Non-Invasive Imaging 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	Device: AM4113-N5UT Dino-Lite

Arm

Intervention/Treatment

Experimental: Non-Invasive Imaging

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

Device: AM4113-N5UT Dino-Lite

Outcome Measures

Primary Outcome Measures

Video of nail-fold imaging captured by capillaroscope [4 weeks]
Image acquisition from device to then analyze and compare with complete blood counts measured in a standard fashion

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Massachusetts General Hospital	Boston	Massachusetts	United States	02115

Sponsors and Collaborators

Massachusetts General Hospital

Investigators

Principal Investigator: Yi-Bin A Chen, MD, Massachusetts General Hospital

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Yi-Bin A. Chen, MD, Principal Investigator, Massachusetts General Hospital

ClinicalTrials.gov Identifier:

NCT02512666

Other Study ID Numbers:

15-070

First Posted:

Jul 31, 2015

Last Update Posted:

Jun 11, 2018

Last Verified:

Jun 1, 2018

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Keywords provided by Yi-Bin A. Chen, MD, Principal Investigator, Massachusetts General Hospital

Hematologic malignancy

Additional relevant MeSH terms:

Neoplasms

Hematologic Neoplasms

Study Results

No Results Posted as of Jun 11, 2018