Characterizing In Vivo Oral Lesion Impedances

Oral Lesion Clinical Trial

Official title:

Characterizing In Vivo Oral Lesion Impedances

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05430477
• Other study ID #: STUDY02001317
• Secondary ID: R21DE031095-01
• Status: Recruiting
• Start date: August 29, 2022
• Est. completion date: December 2024

Study information

• Verified date: December 2023
• Source: Dartmouth-Hitchcock Medical Center
• Contact: Kathy Phipps, BA
• Phone: 6036465793
• Email: kathy.j.phipps[@]dartmouth.edu
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 260
• Est. completion date: December 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Oral Lesion
• Oral Ulcer

Intervention

Device:
• Electrical impedance imaging using Non-Significant Risk device (EII probe)
novel small field-of-view Non-Significant Risk device (EII probe)

Locations

Country	Name	City	State
United States	Dartmouth-Hitchcock Medical Center	Lebanon	New Hampshire

Sponsors (4)

Lead Sponsor	Collaborator
Ryan J. Halter	Dartmouth College, National Institute of Dental and Craniofacial Research (NIDCR), National Institutes of Health (NIH)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Differences in Electrical Impedance	This study will use a custom device to measure differences in electrical impedance between normal, benign, premalignant, and malignant oral lesions.	Participants are on study only the day of the procedure.
Secondary	Images and Measurements Database Creation	Images and in vivo electrical impedance spectra measurements taken for each participant on the day of the procedure will be used to create a database.	Participants are on study only the day of the procedure.