NCT02851420: SpectrORL1

Spectrometry of Cancerous Lesions of the Oral Cavity

Completed NA Last updated 4 September 2019

What this trial tests

NA trial testing spectroscopy in Cancerous Lesions of the Oral Cavity in 69 participants. Completed in 13 June 2019.

Timeline

15 February 2016

Primary endpoint
13 June 2019

13 June 2019

Quick facts

Lead sponsor	Centre Hospitalier Universitaire Dijon
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	non randomized
Design	parallel
Masking	none
Primary purpose	diagnostic
Enrollment	69
Start date	15 February 2016
Primary completion	13 June 2019
Estimated completion	13 June 2019
Sites	1 location across France

Drugs / interventions tested

• spectroscopy

Conditions studied

• Cancerous Lesions of the Oral Cavity — all drugs for Cancerous Lesions of the Oral Cavity →

Sponsor

Centre Hospitalier Universitaire Dijon

Who can join

Eligibility, any sex, with Cancerous Lesions of the Oral Cavity. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

The detection of suspect lesions is based on the clinical examination of the oral cavity and pharyngolaryngeal endoscopy, but the examination to confirm the diagnosis is a pathology examination of the biopsy taken during the endoscopy. Taking the biopsy, however, can be difficult. On the one hand , it is an invasive procedure, and may engender complications, and on the other hand, certain modifications of the mucosa may be discrete, or not particularly specific or, on the contrary, disseminated or extremely widespread.

Non-invasive tools to help the diagnosis could prove to be particularly interesting 1) to restrict the use of biopsies to patients in whom it is really necessary 2) and to identify the area where the biopsy should be done in cases of multiple lesions. In this context, spectroscopy could be a promising alternative.

The investigator puts forward the hypothesis that cancerous and precancerous lesions of the mucosa of the upper airways and digestive tract present a characteristic spectrometric profile. Indeed, as malignant tumours are hypervascularized and as precancerous tumours show signs of angiogenesis, investigators expect that the reflectance of haemoglobin will be diminished in the specific wavelengths of 540 and 575 nm, corresponding to the principal wavelengths absorbed by haemoglobin.

This pilot study will make it possible to construct an algorithm that could be used to classify lesions of the upper airways and digestive tract as either seemingly benign or cancerous.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.