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Can a Light-Based device spot dangerous infection risk without a blood draw?

NCT ID NCT06323447

Diagnosis Sponsor: Leuko Labs, Inc. Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 31, 2026 · Last updated Jul 31, 2026

Summary

This trial evaluates a new device called PointCheck that aims to detect severe neutropenia—a dangerous drop in infection-fighting white blood cells—without needing a blood sample. The study includes about 210 people with diffuse large B-cell lymphoma or multiple myeloma who are receiving chemotherapy that carries a risk of neutropenia. Researchers will compare the device's readings to standard blood tests to see how accurate, reliable, and easy to use it is.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
PointCheck, a non-invasive diagnostic device that uses light to detect severe neutropenia without a blood draw
What this could lead to
If successful, this device could offer a quick, needle-free way to monitor white blood cell counts, potentially reducing infections and hospital visits for cancer patients.
What could go wrong
The device is still being validated, and its accuracy may not match standard blood tests. It is intended as a preliminary screening tool, not a replacement for lab tests.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Participants

About 210 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2025

Expected to finish

Jun 2027

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Who is studied

This is a multi-site (4 US sites) observational open-label diagnostic study of a non-significant risk medical device, PointCheckTM. Participants (N=210) with specific malignancies who are scheduled to receive antineoplastic therapy will be evaluated during their routine management before the planned cytotoxic drug administration at two-time points (baseline and nadir evaluation). This will be an event-driven study with a total number of 70 positive cases (ANC \< 500 cells/mm3) and 140 negative cases (ANC \>= 500 cells/mm3) has been considered sufficient to provide accurate estimates of Sensitivity and Specificity. They will have concurrent evaluations with PointCheckTM and a blood differential cell count in addition to the standard clinical visits. A subset (N=45) of patients will be evaluated for between-instrument reproducibility. Finally, a sub-study (N=30) will confirm the usability of PointCheckTM in the home setting.

Ages

10 years and older

Sex

Anyone

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

Inclusion Criteria: * 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 Criteria: * Participants with amputations, congenital malformations or any severe abnormalities of the hands as determined by the investigator. * 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 circulating tumour cells in previous or current lab determinations. * Participants with any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor). * Unstable participants or participants with hypotension (systolic blood pressure \<90 and diastolic blood pressure \< 60mmHg). * 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. * Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.

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Conditions

The condition(s) this trial relates to.

diffuse large B-cell lymphoma plasma cell myeloma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diffuse large B-cell lymphoma Multiple myeloma

Contacts and locations

Locations

  • Hackensack University Medical Center

    Hackensack, New Jersey, 07601, United States

  • Hospital Universitario 12 de Octubre

    Madrid, 28041, Spain

  • MDA

    Houston, Texas, 77030, United States

  • Massachussetts General Hospital

    Boston, Massachusetts, 02114, United States

  • Norton Healthcare Cancer Center

    Louisville, Kentucky, 40241, United States

  • University of Hawaii Cancer Center

    Honolulu, Hawaii, 96813, United States

More trials for these conditions

Other studies related to the condition(s) this trial covers.