Assessing electrical properties of oral lesions
Characterizing In Vivo Oral Lesion Impedances
This study is testing a special device to see if measuring the electrical properties of oral lesions can help doctors tell the difference between normal, benign, and cancerous growths in patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 260 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | Dartmouth-Hitchcock Medical Center Academic / other |
| Locations | 1 site (Lebanon, New Hampshire) |
| Trial ID | NCT05430477 on ClinicalTrials.gov |
What this trial studies
This study aims to differentiate between normal, benign, premalignant, and malignant oral lesions by measuring their electrical impedance using a custom device. It involves two cohorts: one with patients undergoing oral lesion biopsies and another with patients scheduled for oral cancer resection. The study will collect data on electrical impedance and create a database of in vivo spectra and images of oral lesions. The device used is designed for high precision and accuracy in measuring impedance, complying with safety standards.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with suspected cancer in the oral cavity or related areas requiring biopsy or resection.
Not a fit: Patients who have had a previous oral biopsy within the last 30 days or those with implanted electrical devices may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could improve the diagnostic accuracy of oral lesions, aiding in early detection and treatment of oral cancers.
How similar studies have performed: While this approach is novel in its specific application to oral lesions, similar electrical impedance techniques have shown promise in other medical fields.
Eligibility criteria
Show full inclusion / exclusion 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.
Where this trial is running
Lebanon, New Hampshire
- Dartmouth-Hitchcock Medical Center — Lebanon, New Hampshire, United States (Recruiting)
Study contacts
- Principal investigator: Ryan Halter, PhD — Trustees of Dartmouth College
- Study coordinator: Kathy Phipps, BA
- Email: kathy.j.phipps@dartmouth.edu
- Phone: 6036465793
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.