Frontlight ResearchEarly access
Taking people in United StatesNo phase
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.
Key facts
- Who runs it
- Leuko Labs, Inc.
- Where
- Boston, Hackensack, Honolulu, Houston, and Louisville, United StatesSee the 5 sitesAlso in 1 other country, 1 site
- Trial code
- Registry title
- Pivotal Study to Validate a Novel System to Non-Invasively Detect Severe Neutropenia
- Status
- Recruiting
- People taking part
- 210 people, planned
- Started
- 15 Dec 2025
- Expected to end
- 30 Jun 2027
- Type of study
- Observational
- Treatments tested
- PointCheck
- Record updated
- 3 November 2026
Who can take part
AI summary
From the trial's eligibility criteria. Machine-read from the registry text on this page, so it can be wrong. The registry text below and the trial team decide who can take part.
The trial is looking for people aged 10 or older with diffuse large B cell lymphoma or multiple myeloma. They must be scheduled for cancer treatment with a high or intermediate risk of neutropenia (a very low white blood cell count).
- Age
- 10 years or above
- Sex
- All sexes (male or female)
- Disease stage
- Diagnosed with diffuse large B cell lymphoma or multiple myeloma.
- Earlier treatment
- Scheduled to receive an anticancer therapy with a high or intermediate risk of neutropenia, according to NCCN guidelines.
Main reasons for not taking part
- Amputations, birth defects or severe abnormalities of the hands
- History of vasculitis, Raynaud syndrome, scleroderma, mixed connective tissue disease or another rheumatologic condition that could change small blood flow in the nailfold
- Circulating tumour cells in previous or current lab tests
- Any condition causing significant tremor, such as essential tremor or Parkinson's disease
- Unstable health or low blood pressure (systolic below 90 and diastolic below 60 mmHg)
The registry criteria, word for word
Show all 12 criteriaShow less
Who can take part
- 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
Who cannot take part
- 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
Where in United States
Also in 1 other country, 1 site
- Massachussetts General HospitalBoston, United StatesContact: Patrick Connor Johnson, MDTaking people
- Hackensack University Medical CenterHackensack, United StatesContact: Andrew Ip, MDTaking people
- University of Hawaii Cancer CenterHonolulu, United StatesContact: Toshiake Iwase, MDTaking people
- MDAHouston, United StatesContact: Chijioke Nze, MDTaking people
- Norton Healthcare Cancer CenterLouisville, United StatesContact: Don Stevens, MDTaking people
About the trial
What the trial wants to find out
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.
Treatments tested
- PointCheck
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?
Contact the study team: see the registry record → Contacts and Locations
Print a page for my doctorData and sources
- Registry record
- Listed on ClinicalTrials.gov.
- Official title
- Pivotal Study to Validate the Usability, Safety and Diagnostic Performance of a Novel System to Non-Invasively Detect Severe Neutropenia
- Plain-language title
- Tests a non-invasive device for detecting low white blood cell counts in cancer patientsGenerated from the registry record. The registry title is the official one.
- AI summary
- From the trial's eligibility criteria. Read by machine on 12 November 2026.
- Record updated
- 3 November 2026