PC001- A Study to Evaluate the Usability of PointCheck

Neoplasms Clinical Trial

Official title:

PC001 - Study to Evaluate the Usability of PointCheck, a Novel Optical Technology for Screening Non-Invasively Severe Neutropenia

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04448301
• Other study ID #: H-39964
• Status: Completed
• Phase: N/A
• Start date: February 9, 2021
• Est. completion date: June 30, 2023

Study information

• Verified date: August 2023
• Source: Leuko Labs, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This a study about the usability of PointCheck a novel non-invasive technology for monitoring chemotherapy-induced neutropenia.

The study will include patients with cancer visiting the outpatient hematology clinic for their standard of care chemotherapy administration. A final sample size of 90 oncologic outpatients will be enrolled and studied with the technology.

The main objective is to evaluate the usability of PointCheck. Secondary outcomes include a preliminary assessment of PointCheck diagnostic accuracy and precision.

For this, study subjects will be tested twice with PointCheck during the same session and the usability in an at-home simulated environment by naïve users will be evaluated

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: June 30, 2023
• Est. primary completion date: June 30, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

1. 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.

2. Male or Female aged 18 years or above.

3. Diagnosed with a hematological (e.g., lymphoma, myeloma) or breast cancer.

4. Scheduled active treatment with cytotoxic chemotherapy with an associated high/intermediate risk of neutropenia.

5. Able (in the Investigators opinion) and willing to comply with all study requirements

Exclusion Criteria

1. Participants with amputations, congenital malformations, or any severe abnormalities of the hands as determined by the investigator.

2. 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.

3. Participants with circulating tumour cells in previous or current lab determinations.

4. Participants with leukemia.

5. Participants with any condition producing significant tremor (e.g., essential tremor, Parkinson´s disease, dystonic tremor).

6. Inadequately medically controlled hypotension (systolic blood pressure <90 and diastolic blood pressure < 60mmHg).

7. Participants whose gold standard blood differential was obtained more than 120 minutes after the last evaluation with the medical device.

8. 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.

9. Other unspecified reasons that, in the opinion of the Investigator or Sponsor, make the subject unsuitable for enrolment.

Related Conditions & MeSH terms

• Neoplasms
• Neutropenia

Intervention

Diagnostic Test:
• PointCheck
This is a usability study on PointCheck, a new technology to detect chemotherapy-induced neutropenia

Locations

Country	Name	City	State
United States	Boston Medical Center	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Leuko Labs, Inc.	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Diagnostic performance for a second cutoff	The preliminary diagnostic accuracy to detect grade III neutropenia according to CTCAE V5 (<1000 ANC/mm3) measured by the sensitivity and the specificity will be the evaluated with reference to the corresponding laboratory measures acquired.	Up to three-weeks
Primary	PointCheck's Usability	To gather data with the ultimate goal of determining the usability of the proposed non-invasive method measured by the number of errors of correct videos acquired for analyses.	Up to two-weeks
Primary	System Usability Scale (0-100 higher scores indicates better usability)	To confirm the usability of the system using the System Usability Scale	Up to three-weeks
Secondary	PointCheck's Precision	To perform an exploratory analysis of the precision of PointCheck's estimation of neutropenia status from two independent one-minute videos.	Up to two-weeks
Secondary	PointCheck's Accuracy	To perform a exploratory analysis of PointCheck's accuracy (e.g., sensitivity, specificity, predictive values) to detect severe neutropenia compared with the gold standard blood analysis method employed by Boston Medical Center core laboratory in the range between =500 and >500 absolute neutrophil count/µL.	Up to three-weeks
Secondary	PointCheck's Utility	To evaluate the number of patients that had to be rescheduled because the sole presence of neutropenia and how many of them were correctly detected with PointCheck.	Up to three-weeks
Secondary	Number of participants with device-related adverse events as assessed by CTCAE v5.0	To confirm PointCheck's safety determining the % of AEs and SAEs related to the device use.	Up to three-weeks