None listed
Conditions
Brief summary
An ultrasound device developed for periodontal disease diagnosis will be tested for its capability to distinguish cancerous lesions from non-cancerous lesions based on elasticity parameters. Patients referred to dental school by primary physician for biopsy followed by histopathology of suspected cancer lesion will be approached. After obtaining consent, the device will be touched to the lesion and measurements obtained. These will be correlated to malignancy status of the lesion.
Interventions
20 patients will be recruited from patients referred to the Oral Medicine Unit at the Faculty of Dentistry, University of Otago for suspicion of cancer.
Ultrasound measurements will be made using the Periomedic ultrasound device. The protocol followed is identical to that followed in our previous pilot study, conducted with HDEC Ethics approval (ACTRN12623000463673). Ultrasound recordings of the lesion will be obtained by touching the tip of the device, covered by a latex sterile sheath. The le
20 patients will be recruited from patients referred to the Oral Medicine Unit at the Faculty of Dentistry, University of Otago for suspicion of cancer. Ultrasound measurements will be made using the Periomedic ultrasound device. The protocol followed is identical to that followed in our previous pilot study, conducted with HDEC Ethics approval (ACTRN12623000463673). Ultrasound recordings of the lesion will be obtained by touching the tip of the device, covered by a latex sterile sheath. The lesion may be supported using sterile aluminum foil. Medical-grade glycerol will be applied external to the sterile sheath to act as an ultrasound coupling medium. Three to five readings will be taken, each requiring approximately 10 seconds. The collected data will be saved using anonymous numbers assigned to identify each participant’s dataset. The intervention will be administered by clinician who manages oral cancer patients.
Sponsors
Periomedic Limited
Study design
Allocation
Non-randomised trial
Primary purpose
Diagnosis
Masking
Open (masking not used)
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
An oral lesion “causing suspicion of intraepithelial neoplasia” or frank malignancy necessitating immediate biopsy.
Exclusion criteria
Orofacial cancers that are not in the oral cavity, such as cancer of the pinna, skin cancers and melanoma will be excluded.
Outcome results
None listed