Non Invasive Optical Imaging of WBC Count

Hematologic Malignancy Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02512666
• Other study ID #: 15-070
• Status: Completed
• Phase: N/A
• Start date: September 2015
• Est. completion date: September 2017

Study information

• Verified date: June 2018
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 45
• Est. completion date: September 2017
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Hematologic Malignancy
• Neoplasms

Intervention

Device:
• AM4113-N5UT Dino-Lite

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Massachusetts General Hospital

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	4 weeks