Clinical trial NCT05430477: Characterizing In Vivo Oral Lesion Impedances
Official title: Characterizing In Vivo Oral Lesion Impedances
Study type: OBSERVATIONAL
Overall status: RECRUITING
Conditions: Oral Lesion
Keywords: electrical impedance tomography (EIT)
Oral Lesion
Lead sponsor: Dartmouth-Hitchcock Medical Center
Sponsor class: OTHER
Collaborators: name: National Institutes of Health (NIH)
name: National Institute of Dental and Craniofacial Research (NIDCR)
name: Dartmouth College
First posted: 2022-06-24
Enrollment: 260
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
Study population: 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. This study will enroll 250 subjects in two cohorts. Cohort I will consist of 200 patients undergoing oral lesion biopsies. 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.

Brief summary: 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: 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:

1. measurement precision \~85 dB,
2. accuracy \>99%,
3. bandwidth extending to 1 MHz, and
4. 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.

Eligibility criteria: Cohort 1 10.1.1 Inclusion Criteria

1. Suspected cancer the oral cavity, oropharynx, hypopharynx, or larynx requiring biopsy.
2. Ability to understand and the willingness to sign a written informed consent document.
3. Age ≥ 18 years old.
4. If a female of child bearing potential, then a negative pregnancy evaluation per standard of care.

10.1.2 Exclusion Criteria

1. Adults having had a previous oral biopsy within the last 30 days
2. Adults with implanted electrical devices such as pacemakers
3. Prisoners
4. Adults with impaired decision-making capacity
5. Has any condition for which, in the opinion of the investigator, contraindicates study participation.

Cohort 2 10.2.2 Inclusion Criteria

1. Clinical diagnosis or suspected cancer the oral cavity, oropharynx, hypopharynx, or larynx requiring resection.
2. Ability to understand and the willingness to sign a written informed consent document.
3. Age ≥ 18 years old
4. If a female of child bearing potential, then a negative pregnancy evaluation per standard of care.

10.2.3 Exclusion Criteria

1. Adults with implanted electrical devices such as pacemakers
2. Prisoners
3. Adults with impaired decision-making capacity
4. Any condition for which, in the opinion of the investigator, contraindicates study participation.

Primary outcomes:
measure: Differences in Electrical Impedance
timeFrame: Participants are on study only the day of the procedure.
Secondary outcomes:
measure: Images and Measurements Database Creation
timeFrame: Participants are on study only the day of the procedure.
Other outcomes:
Locations:
city: Lebanon
country: United States
facility: Dartmouth-Hitchcock Medical Center
state: New Hampshire
Study officials:
affiliation: Trustees of Dartmouth College
name: Ryan Halter, PhD
role: PRINCIPAL_INVESTIGATOR
References: