Non Invasive Optical Imaging of WBC Count

Mass General Brigham

Status: Completed

Conditions: Hematologic Malignancy

Treatments: Device: AM4113-N5UT Dino-Lite

Study type: Interventional

Funder types: Other

Identifiers

NCT02512666

15-070

Details and patient eligibility

About

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.

Full 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.

Enrollment: 45 patients

Sex: All

Ages: 18+ years old

Volunteers: No 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.

Trial design

Primary purpose: Device Feasibility

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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45 participants in 1 patient group

Non-Invasive Imaging

Experimental group

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

Treatment:

Device: AM4113-N5UT Dino-Lite