Tests a non-invasive device for detecting low white blood cell counts in cancer patients
Tests PointCheck, a needle-free device, in people with lymphoma or myeloma.
Plain-language title generated from the registry record
Registry title: Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia
Key facts
- Where
- Boston, Hackensack, Honolulu, Houston, and Louisville, United StatesSee the 5 sites
Where in United States
- Massachussetts General HospitalBoston, United StatesTaking people
- Hackensack University Medical CenterHackensack, United StatesTaking people
- University of Hawaii Cancer CenterHonolulu, United StatesTaking people
- MDAHouston, United StatesTaking people
- Norton Healthcare Cancer CenterLouisville, United StatesTaking people
Questions to ask the study team
- How often do I need to come in, and for how long each time?
- Are travel costs paid?
- Can I keep my own doctor?
- What happens if I want to stop?
Trial details
- Who runs it
- Leuko Labs, Inc.
- Trial code
- NCT06323447
- Record updated
- 3 November 2026
- Original description
Pivotal study to validate the diagnostic performance of PointCheck, the first non invasive device to preliminary detect neutropenia in cancer patients receiving intermediate/high risk antineoplastic therapy.Read full original descriptionShow less
Pivotal Study to Validate the Usability, Safety and Diagnostic Performance of a Novel System to Non-Invasively Detect Severe Neutropenia
Pivotal study to validate the diagnostic performance of PointCheck, the first non invasive device to preliminary detect neutropenia in cancer patients receiving intermediate/high risk antineoplastic therapy.
Inclusion: Able to understand the purpose and risks of the study and to provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations; Male or Female aged 10 years or above; Diagnosed with either Diffuse Large B Cell Lymphoma or Multiple Myeloma; Scheduled treatment with any antineoplastic therapy with an associated high/intermediate risk of neutropenia according to NCCN guidelines; Able (in the investigator's opinion) and willing to comply with all study requirements.
Exclusion: Participants with circulating tumour cells in previous or current lab determinations; Participants with a history of vasculitis, Raynaud syndrome, scleroderma, mixed connective tissue disease or any other rheumatologic systemic condition that could produce microcirculatory changes in the nailfold; Participants with any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor); Any other significant disease or disorder which, in the opinion of the Investigator, may either put the participants at risk because of participation in the study, or may influence the result of the study, or the participant's ability to participate in the study; Participants with amputations, congenital malformations or any severe abnormalities of the hands as determined by the investigator; Unstable participants or participants with hypotension (systolic blood pressure <90 and diastolic blood pressure < 60mmHg); Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.