Characterizing In Vivo Oral Lesion Impedances

Study Overview
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Brief Summary
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The primary objective of this study is to demonstrate a significant difference in electrical impedance between normal, benign, premalignant, and malignant oral lesions using a custom device. The secondary study objective is to create a database of in vivo electrical impedance spectra and images of oral lesions. This will be achieved by collecting Electrical Impedance sensing data and images from two cohorts of patients: Cohort I will consist of 200 patients undergoing oral lesion biopsies and Cohort II will be comprised of 50 patients scheduled for oral cancer resection. A maximum of 5 additional subjects will be initially enrolled in each Cohort to optimize data acquisition.

Detailed Description
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For this study, a novel small field-of-view EII probe will be used for recording impedances from oral lesions. The device is comprised of gold-plated electrodes with analog electronics located in the probe's tip, to minimize cable lengths and maximize the signal-to-noise ratio. A pressure sensor is embedded within the probe to reduce variability in the amount of pressure used when the probe is applied to soft tissue. The bioimpedance-sensing probe is designed to the following specifications in order to accurately assess oral lesions: measurement precision  85 dB, accuracy >99%, bandwidth extending to 1 MHz, and multi-frequency sample rate of >10 impedance spectra per second. Similar to other EII systems the team has developed and deployed in vivo, the system complies with International Electrotechnical Commission (IEC) requirements for safety and essential performance of medical electrical equipment (IEC 60601-1). There are no known probes cleared by the FDA for this application. The study is not being conducted in order to evaluate the EII probe's safety or effectiveness in human subjects, nor to test the device for marketing or promotion.

Official Title
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Characterizing In Vivo Oral Lesion Impedances

Conditions
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Oral Lesion

Intervention / Treatment
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* Device: Electrical impedance imaging (EII) probe


Participation Criteria
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Eligibility Criteria
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Cohort 1 10.1.1 Inclusion Criteria Suspected cancer the oral cavity, oropharynx, hypopharynx, or larynx requiring biopsy. Ability to understand and the willingness to sign a written informed consent document. Age ≥ 18 years old. If a female of child bearing potential, then a negative pregnancy evaluation per standard of care. 10.1.2 Exclusion Criteria Adults having had a previous oral biopsy within the last 30 days Adults with implanted electrical devices such as pacemakers Prisoners Adults with impaired decision-making capacity Has any condition for which, in the opinion of the investigator, contraindicates study participation. Cohort 2 10.2.2 Inclusion Criteria Clinical diagnosis or suspected cancer the oral cavity, oropharynx, hypopharynx, or larynx requiring resection. Ability to understand and the willingness to sign a written informed consent document. Age ≥ 18 years old If a female of child bearing potential, then a negative pregnancy evaluation per standard of care. 10.2.3 Exclusion Criteria Adults with implanted electrical devices such as pacemakers Prisoners Adults with impaired decision-making capacity Any condition for which, in the opinion of the investigator, contraindicates study participation.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Cohort 1<br>Subjects recruited to Cohort I will include patients who are scheduled to undergo oral lesion biopsy as well as patients who are determined to need a biopsy at the time of visual examination, which often occurs in-clinic. Cohort I will consist of 200 oral lesion biopsy patients total. Prior to the start of enrollment in this Cohort, up to 5 additional subjects will be enrolled to optimize the data acquisition process. | Device: Electrical impedance imaging (EII) probe<br>* novel small field-of-view EII probe<br>|
| Cohort 2<br>Potential study participants will be identified through Dartmouth-Hitchcock Medical Center (DHMC)'s Head and Neck Tumor Clinic, and will be patients with diagnosed or suspected cancer of the oral cavity, oropharynx, hypopharynx, or larynx who require biopsy or resection for either diagnostic or therapeutic purposes. Cohort II will be comprised of 50 patients undergoing oral cavity cancer resections. Initially, up to 5 subjects will be enrolled in addition to the 50 patients in this Cohort in order to optimize the data acquisition process. | Device: Electrical impedance imaging (EII) probe<br>* novel small field-of-view EII probe<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome 1 | This study will use a custom device to measure differences in electrical impedance between normal, benign, premalignant, and malignant oral lesions. | thru 2024 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Outcome 2 | A database of in vivo electrical impedance spectra and images of oral lesions will be created. | thru 2024 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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electrical impedance tomography (EIT), Oral Lesion