Skip to main content
OpenTrials
Completed

NCT Number: NCT06415656

VitalTraq for the Detection of CRS

The purpose of this study is to evaluate two vital sign monitoring devices, TempTraq and VitalTraq, in patients with hematologic malignancies undergoing therapy with Chimeric antigen receptor T-cell therapy (CAR-T) or Bispecific T-cell engagers (BiTE) products. TempTraq is an axillary patch that is worn on the skin and continuously monitors a patient's body temperature. VitalTraq is a smartphone application that utilizes remote photoplethysmography technology via a 30-second facial scan to estimate the patient's blood pressure (BP), heart rate (HR), heart rate variability (HRV), and respiratory rate. These remote vital sign monitoring devices have the potential to promote earlier detection and intervention of treatment-related toxicities, including cytokine release syndrome (CRS) and febrile neutropenia.

Completed

Looking for future studies?

Notify Me

Key information

Conditions

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

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Duke Blood Cancer Center

Durham, North Carolina, 27705, United States

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Adults at or over the age of 18 with hematologic malignancies undergoing treatment with chimeric antigen receptor (CAR) T-cell therapy or bispecific T-cell engagers (BiTE), as follows:
  • Axicabtagene ciloleucel
  • Lisocabtagene maraleucel
  • Brexucabtagene autoleucel
  • Idecabtagene vicleucel
  • Ciltacabtagene autoleucel
  • Obecabtagene autoleucel
  • Tisagenlecleucel
  • Blinatumomab
  • Mosunetuzumab
  • Talquetamab
  • Elranatamab
  • Teclistamab
  • Glofitamab
  • Owns a smart phone (e.g., iPhone, Android, Samsung) that is compatible with the VitalTraq app and that can connect to wi-fi. This will be assessed at screening.
  • Able to read and understand English
  • Willing and able to provide informed consent to the study

Exclusion criteria

  • Receiving a non-FDA approved CAR-T or BiTE product
  • Receiving Epcoritamab

Treatment and study plan

TempTraq

Device

TempTraq (Blue Spark Technologies, Westlake, OH) is an FDA 510K cleared wearable, wireless temperature monitoring patch designed to continuously monitor and track body temperature.

VitalTraq

Device

VitalTraq (Blue Spark Technologies, Westlake, OH) is an experimental and novel multi-vital sign monitoring platform that allows for interval measurements of heart rate, heart rate variability, and blood pressure.

Primary outcomes

  1. TempTraq's Ability to Measure Axillary Temperature in the Intended Use Population

    Time frame: Day 14

    Body temperature (degrees Celsius) data will be measured as a continuous variable via the TempTraq device and via standard-of-care oral thermometers. Reported as the difference between the two measurements (TempTraq - SOC thermometers).

Secondary outcomes

  1. Lead Time by Which Fevers Can be Detected Using TempTraq Compared to SOC Interval Oral Thermometer Measurements

    Time frame: Day 14

    The times to first detection of fever, if applicable, will be measured for each patient using temperature data derived from the TempTraq device and standard-of-care oral thermometers. The mean time to first fever (i.e., temperature > 38 degrees Celsius), will be calculated and described for both the TempTraq device and standard-of-care oral thermometers. Reported as the difference between the two measurements (TempTraq - SOC thermometers).

  2. VitalTraq's Ability to Measure Blood Pressure in the Intended Use Population.

    Time frame: Day 14

    Determined by use of an equivalence test to test the hypothesis that there is no difference in the systolic and diastolic measurements using VitalTraq compared to SOC interval vitals measurements. The smallest tolerable differences in systolic and diastolic blood pressure are set to be 20 mmHg and 10 mmHg, respectively. Reported as the difference between the two measurements (TempTraq - SOC).

  3. VitalTraq's Ability to Measure Heart Rate in the Intended Use Population.

    Time frame: Day 14

    Determined by use of an equivalence test to test the hypothesis that there is no difference in the heart rate measurements using VitalTraq compared to SOC interval oral thermometer measurements. The smallest tolerable difference is set to be 10 beats per minute. Reported as the difference between the two measurements (TempTraq - SOC).

  4. Patient's Perspective on the Burden of Using TempTraq and VitalTraq

    Time frame: Day 28

    Individual questions in a post-intervention survey feature 7-point Likert scale responses, where 1=strongly agree and 7=strongly disagree. The mean score is reported, giving a score range of 1 to 7, where a lower score indicates lower burden.

  5. Lead Time by Which TempTraq and VitalTraq Can Detect Grade 2 or Higher Cytokine Release Syndrome (CRS) as Compared to the Standard of Care.

    Time frame: Day 14

    The times to first detection of grade 2 or higher CRS, if applicable, will be measured for each patient using vitals data derived from the TempTraq and VitalTraq devices, as well as via standard-of-care vitals measurements. The mean time to first detection of grade 2 or higher CRS will be calculated and described for both the investigational devices and standard-of-care monitoring. Reported as the difference between the two measurements (TempTraq - SOC).

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Blue Spark Technologies

Registry information

Official study title

Digital Multi-Vital Sign Monitoring for Early Detection of Cytokine Release Syndrome From Bispecific T-Cell Engagers and Chimeric Antigen Receptor Therapy

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 16, 2024
Registry last updated
Jul 15, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.