Non Invasive Optical Imaging of WBC Count

NCT02512666 | Completed

• 1 other identifier: 15-070
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

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.

Conditions

Hematologic Malignancy

Keywords

Hematologic malignancy

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (1)

Non-Invasive Imaging

EXPERIMENTAL

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

Device: AM4113-N5UT Dino-Lite

Interventions

AM4113-N5UT Dino-Lite DEVICE

Non-Invasive Imaging

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• History of allergic reactions attributed to compounds of similar chemical or biologic composition of baby oil.
• Myelodysplasia
• Skin phototype \< 4 in the Fitzpatrick scale.

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02115, United States

Location

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Hematologic Diseases; Hemic and Lymphatic Diseases

Study Officials

• Yi-Bin A Chen, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DEVICE FEASIBILITY
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: July 28, 2015
• First Posted: July 31, 2015
• Study Start: September 1, 2015
• Primary Completion: September 1, 2017
• Study Completion: September 1, 2017
• Last Updated: June 11, 2018

Record last verified: 2018-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)