Usability, Adherence and Diagnostic Performance of PointCheck in Pediatric Population

NCT04889937 | Completed FDA Device

• 1 other identifier: MDACC Protocol ID: 2021-0061
• Study Type: observational
• Target: 46
• Locations: 1 country
• Sites: 1

Brief Summary

Single-site non-significant risk, open-label clinical investigation designed to validate the usability, adherence, and preliminary diagnostic performance of a novel technology to detect neutropenia. Study participants will be managed as per the standard of care practice with a baseline and nadir visit including laboratory determinations. Participants will also be evaluated with the device at both time points and with daily measurements during the two-week period in between.

Conditions

Hematologic Malignancy

Outcome Measures

Primary Outcomes (1)

• Usability of PointCheck

  The study will confirm if participants can acquire good quality videos in a home like setting. The System Usability Scale (0-100 higher scored indicate a better usability) will be completed by the participants after completing the follow up visit.

  Up to three-weeks

Secondary Outcomes (4)

• Accuracy of PointCheck

  Up to three-weeks

• Repeatability of PointCheck

  Up to three-weeks

• Number of participants with device-related adverse events as assessed by CTCAE v5.0

  Up to three-weeks

• Adherence to PointCheck

  Up to three-weeks

Other Outcomes (3)

• Predictive capacity of PointCheck

  Up to three-weeks

• Diagnostic performance for a second cutoff

  Up to three-weeks

• Clinical Utility Assessment

  Up to three-weeks

Study Arms (1)

PC004 Cohort

The study will include a sample of patients with specific cancer types visiting the outpatient hematologic oncology clinic for their standard of care chemotherapy administration. Participants will need to be willing to participate and be able to provide written informed consent

Device: PointCheck

Interventions

PointCheck DEVICE

PointCheckTM is intended for use to aid in the assessment of severe neutropenia in the home or clinic setting in subjects receiving myelosuppressive chemotherapy with intermediate to high febrile neutropenia risk. The device non-invasively captures real-time videos of blood flow in the nailfold microcirculation and utilizes visible light, a microscope and a computer vision software to provide a qualitative result. The device is limited to use as a preliminary assessment tool in conjunction with standard of care, including temperature monitoring and clinical assessment. It is not to be used as a stand-alone determinant of severe neutropenia or for any other diagnostic purpose

PC004 Cohort

Eligibility Criteria

• Age: 7 Years - 39 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

The study will be conducted in children, and adults diagnosed with cancer that require cytotoxic chemotherapies that could lead to febrile neutropenia. Patients with Diffuse Large B-Cell Non-Hodgkin Lymphoma (DLBCL) and breast cancer who are scheduled to receive cytotoxic chemotherapy agents with high (\>20%) or intermediate (10-20%) risk of neutropenia will be the main target. However, all adult patients with Hodgkin/Non-Hodgkin Lymphoma and breast cancer and all children with solid or liquid tumors (see inclusion and exclusion criteria) whose therapy has an intermediate or high-risk of febrile neutropenia, are eligible. The main factor to select the populations will therefore be the estimated risk of severe neutropenia from the chemotherapy used. Patients under any other regimen that have an associated FN risk greater than 10% will be considered eligible.

You may qualify if:

• Study subjects, or their parent/legal guardian for subjects \<18 years, must be able to understand the purpose and risks of the study and provide signed and dated informed consent and authorization to use confidential health information in accordance with national and local subject privacy regulations. Subjects between the ages of 7 and 17.9 years must provide assent.
• Male or Female aged 7 years to 65 years.
• Adults (\> 18 years) diagnosed Diagnosed with Hodgkin/Non-Hodgkin Lymphoma or breast cancer.
• Children and adolescents (7 - 18 years) with liquid or solid tumors.
• Scheduled treatment with cytotoxic chemotherapy with an associated high/intermediate risk of neutropenia (table 1) 30.
• Able (in the investigator's opinion) and willing to comply with all study requirements.

You may not qualify if:

• 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 tumor cells in previous or current lab determinations.
• Adult (\>18 years) participants with leukemia of all types and pediatric (7-18 years) participants with leukemia that are either not in remission or in the minimal residual disease category.
• Participants with any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor).
• Unstable participants (pediatric or adults) or adult 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.

Sponsors & Collaborators

• Leuko Labs, Inc.: lead
• M.D. Anderson Cancer Center: collaborator
• Center for Advancing Point of Care Technologies: collaborator

Study Sites (1)

MD Anderson Cancer Center

Houston, Texas, 77030, United States

Location

Related Links

• Sponsor website

MeSH Terms

Conditions

Hematologic Neoplasms

Condition Hierarchy (Ancestors)

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

Study Officials

• Branko Cuglievan, MD

  M.D. Anderson Cancer Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 11, 2021
• First Posted: May 17, 2021
• Study Start: September 7, 2021
• Primary Completion: July 31, 2023
• Study Completion: July 31, 2023
• Last Updated: March 11, 2025

Record last verified: 2025-03

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)