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enteric capsule will be ingested every 24 hours during aplasia. Temperature measurement will be made continuously during aplasia.

In parallel, auricular temperature will be measure every 4 hours during aplasia.

Enteric capsule to measure body temperature will be ingested every 24 hours during aplasia. the temperature measured with this technique will be compared with auricular temperature measurement (in current practice nurse measure temperature every 4 hours during aplasia).

Enteric capsule

Fabrice Jardin, Professor

Doriane Richard, PhD

Fabrice Jardin

Connected medicine "2.0" is a major challenge that will lead in the near future to profound changes in medical practices. Our study is part of this technological transformation, which is already taking the form of multiple devices available to practitioners: connected pill dispensers, integrated monitoring and surveillance systems (telemedicine), connected sensors, etc.

However, a symptom as crucial and simple as body temperature has not been measured by real-time enteric capsule in a context of neutropenia. We therefore wish to study the concordance between the peripheral (tympanic) temperature and that measured by a capsule ingested in a cohort of patients hospitalized in the USIH. If the measurements are clinically reliable and truly allow anticipation of antimicrobial treatments, a medico-economic evaluation will be proposed between the two options in the context of USIH before its possible generalization.

Concordance Between 2 Means of Temperature Measure in Neutropenic Patients Hospitalized in Intensive Hematology Care Units

Concordance Between Body Temperature Measured Per Enteric Capsule and Auricular Temperature in Neutropenic Patients Hospitalized in Intensive Hematology Care Units

the temperature in degrees Celsius measured by the 2 systems (left and right average for the auricular measure) and analysis of the concordance

The time required to start anti-infective treatments according to the 2 measurement methods, in hours (effective start up thanks to the ear and theoretical measurement indicated by the enteric measurement)

Description of curves of temperature in the neutropenic patient measured continuously

Centre Henri Becquerel

Tumors and/or lymph nodes of patients scheduled for standard of care surgery will be imaged using the MSOT device before and after surgery.

The temperature of their skin prior to and after MSOT imaging will also be measured.

The MSOT Device will be used to take images of the tumor and/or lymph nodes of patients with solid tumors before and after surgery to measure the margins of the tumor and/or positive lymph node.

MSOT Device

The temperature of the skin will be measured prior to and after MSOT imaging.

Temperature Measurement

Lacey McNally, PhD

The purpose of this study is to evaluate the safety and potential of a new experimental imaging instrument called multispectral optoacoustic tomography (MSOT) to detect tumors and lymph nodes with tumors.

This study will involve patients that are scheduled for routine standard of care surgery. It is a single-arm study designed to provide safety information regarding the use of the Acuity MSOT device in the clinical setting, and the ability of MSOT imaging data to correlate with clinical findings identified via pathology.

The device will be used to obtain images of the tumor or lymph node margins for investigational use only to compare to clinical pathology and patient's medical record. All images will be obtained pre- and post-surgery in a closed surgical patient. The temperature of the patient's skin will also be measured prior to and after MSOT imaging. MSOT imaging will be for research only and no treatment decisions will be based on the MSOT images obtained.

A Feasibility Study for the Use of Multispectral Optoacoustic Tomography in the Detection of Tumors

A Feasibility Study for the Use of Multispectral Optoacoustic Tomography in the Detection of Solid Tumors and Lymph Nodes (MSOT)

Adverse events as characterized by CTCAE v5.0 in patients that may result from MSOT imaging (≥44 degrees Celsius).

Measurement of skin temperature pre- and post-MSOT imaging (2 measurements total) with a touch thermometer as part of the safety evaluation of the MSOT device. The thermometer will be placed onto the skin until a temperature appears, about 1 minute, and the temperature will be recorded.

Percent of patients who experienced skin temperature readings \>44 degrees Celsius.

MSOT device can identify and differentiate between tumor tissue and surrounding tissue due to detection of different oxygenation states of hemoglobin, with the idea that tumors have differential tissue oxygenation levels compared to non-tumor (control) values. Tumor positivity will be determined based on comparison of oxy-hemoglobin levels using MSOT localization from the same size polygon region of interest (ROI) analysis of the tumor tissue and a sample of non-cancer tissue from the same patient. Increased intensity of signal (output obtained in MSOT Arbitrary Units (MSOT A.U.)) indicates higher levels of oxy-hemoglobin which correlates with tumor tissue as confirmed by comparison with pathology reports. Paired t-tests will be performed and median difference and IQR reported.

MSOT device can identify and differentiate between tumor tissue and surrounding tissue due to detection of different oxygenation states of hemoglobin, with the idea that tumors have differential tissue oxygenation levels compared to non-tumor (control) values. Tumor positivity will be determined based on comparison of deoxy-hemoglobin levels using MSOT localization from the same size polygon region of interest (ROI) analysis of the tumor tissue and a sample of non-cancer tissue from the same patient. Increased intensity of signal (output obtained in MSOT Arbitrary Units (MSOT A.U.)) indicates higher levels of deoxy-hemoglobin which correlates with tumor tissue as confirmed by comparison with pathology reports. Paired t-tests will be performed and median difference and IQR is reported.

Tumor positivity will be compared (yes/no) from the standard pathology report with the MSOT readings. Percent of patients with matching readings will be calculated and reported.

University of Oklahoma

A slight, reversible reddening and temperature increase of sensitive skin. All adverse events and expected treatment effects, including mild events, will be monitored throughout the study until discharge.

The descriptions and grading scales found in the revised NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 will be utilized for AE reporting.

Tumors and/or lymph nodes of patients scheduled for standard of care surgery will be imaged using the MSOT device before and after surgery.

The temperature of their skin prior to and after MSOT imaging will also be measured.

MSOT Device: The MSOT Device will be used to take images of the tumor and/or lymph nodes of patients with solid tumors before and after surgery to measure the margins of the tumor and/or positive lymph node.

Temperature Measurement: The temperature of the skin will be measured prior to and after MSOT imaging.

Imaging of Tumor or Lymph Node

Age, Continuous

Sex: Female, Male

Ethnicity (NIH/OMB)

Race (NIH/OMB)

United States

Region of Enrollment

Weight for two patients was not collected.

Body Mass Index (BMI)

Any participant who met inclusion criteria.

Lacey McNally

Patients who completed pre and post MSOT imaging temperature readings.

Number of Participants With Adverse Events Due to MSOT Imaging

Evaluate Skin Temperature Pre and Post Imaging (Pre- and Post- Surgery)

Patients who underwent MSOT scanning who had usable data (no machine errors)

Tumor Positivity Based on Detection of Oxy-hemoglobin Using MSOT Device.

Tumor Positivity Based on Detection of Deoxy-hemoglobin Using MSOT

Patients with pathology reports and viable MSOT readings

Tumor Positivity From Pathology Reports Compared to MSOT Readings

The MSOT Device was used to take images of the tumor and/or lymph nodes of patients with solid tumors before and after surgery to measure the margins of the tumor and/or positive lymph node.

The temperature of the skin was measured prior to and after MSOT imaging.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Concordance Between 2 Means of Temperature Measure in Neutropenic Patients Hospitalized in Intensive Hematology Care Units	NCT04174053	Haematological ...	Enteric capsule	18 Years -	Centre Henri Becquerel
A Feasibility Study for the Use of Multispectral Optoacoustic Tomography in the Detection of Tumors	NCT04365413	Solid Tumor	MSOT Device Temperature Mea...	18 Years -	University of Oklahoma

Spots Global Cancer Trial Database for temperature measurement