Non Invasive Optical Imaging of WBC Count

Not Applicable

Completed

• Conditions: Hematologic Malignancy
• Interventions: Device: AM4113-N5UT Dino-Lite

• 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

Arm && Interventions

Group	Intervention	Description
Non-Invasive Imaging	AM4113-N5UT Dino-Lite	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

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