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Detecting oral lesions by impedance spectroscopy- a feasibility study

A study to determine the feasibility of using electrical impedance spectroscopy to detect oral lesions

OralDental (co-adopted by Cancer)
Portfolio Eligibility
Automatically eligible
MREC N° 11/H0903/4
UKCRN ID 11052
Research Summary
Study Type Interventional
Design Type Diagnosis
Disease(s) All
All Oral and dental health
Phase Pilot/Feasibility
Current Status Closed - follow-up complete
Closure Date 12/30/2012
Global Sample Size 50
Global Recruitment to Date
Geographical Scope Single Centre
Lead Country England
Main Inclusion Criteria
Inclusion Criteria 1. Patients diagnosed clinically with a suspicious, potentially malignant (provisional clinical diagnosis of leukolakia or erythroplakia) or malignant oral lesion, where a conventional scalpel biopsy has already been performed for diagnostic purposes 2. Patients with a sufficient area of lesion (>8mm diam) still remaining so that impedance measurements can be made 3. Voluntary written signed informed consent 4. The patient has an area of clinically normal oral mucosa on the contralateral side of the mouth >2cms in diam.
Main Exclusion Criteria
Exclusion Criterion 1. Patients with a pacemaker, or other active (electronic) implanted device, will be excluded from the study to preclude any risk of impedance spectroscopy interfering with the pacemaker/device. 2. Patients in whom there is <8mm of lesional tissue left following biopsy or in whom a biopsy was performed <5 days or >18 months prior to assessment for the study. 3. There are no other medical or dental contraindications for participation in the study, but patients who cannot understand the information sheet or consent forms, for whatever reason will be excluded. 4. Subjects under 16 years of age will not be included.
Chief Investigator(s)
Prof Martin Thornhill
Further details, please contact
Miss Katy D'Apice

University of Sheffield
Charles Clifford Dental Hospital

Tel: 0114 2265488
Prof Martin Thornhill

University of Sheffield
Department of Oral & Maxillofacial Medicine & Surgery
14-16 Claremont Crescent
South Yorkshire
S10 2TA

Tel: 0114 271 7857
Funder(s) NIHR Invention for Innovation (i4i)
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