This trial is active, not recruiting.

Condition hematologic malignancy
Treatment am4113-n5ut dino-lite
Sponsor Massachusetts General Hospital
Start date September 2015
End date July 2017
Trial size 35 participants
Trial identifier NCT02512666, 15-070


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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
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
am4113-n5ut dino-lite

Primary Outcomes

Video of nail-fold imaging captured by capillaroscope
time frame: 4 weeks

Eligibility Criteria

Male or female participants at least 18 years old.

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 photoype < 4 in the Fitzpatrick scale.

Additional Information

Official title Non Invasive Optical Imaging of Capillaries Through the Nailfold for White Blood Cell Enumeration in Patients With Hematologic Malignancies
Principal investigator Yi-Bin A Chen, MD
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.
Trial information was received from ClinicalTrials.gov and was last updated in October 2016.
Information provided to ClinicalTrials.gov by Massachusetts General Hospital.