Non Invasive Optical Imaging of WBC Count

Not Applicable

Completed

• Conditions: Hematologic Malignancy

• Registration Number: NCT02512666
• Lead Sponsor: Massachusetts General Hospital

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.

Study Timeline

• Study First Submitted: 2015-07-28
• Study First Submitted QC: 2015-07-29
• Study First Posted: 2015-07-31
• Study Start: 2015-09
• Primary Completion: 2017-09
• Study Completion: 2017-09
• Status Verified: 2018-06
• Last Update Submitted: 2018-06-07
• Last Update Posted: 2018-06-11

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 45

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States