Cancerous Lesions of the Oral Cavity Clinical Trial
— SpectrORL1Official title:
Interest of Spectroscopy in the Diagnosis of Cancerous and Precancerous Lesions of the Upper Airways (UA): Pilot Study
| Verified date | September 2019 |
| Source | Centre Hospitalier Universitaire Dijon |
| Contact | n/a |
| Is FDA regulated | No |
| Health authority | |
| Study type | Interventional |
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.
| Status | Completed |
| Enrollment | 69 |
| Est. completion date | June 13, 2019 |
| Est. primary completion date | June 13, 2019 |
| Accepts healthy volunteers | Accepts Healthy Volunteers |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: patient - Patients consulting at the oto rhino laryngology department of Dijon for a functional symptom of the mouth, pharynx or larynx (pharyngeal discomfort, odynophagia, dysphagia, dysphonia, laryngeal dyspnoea) and in whom the clinical examination reveals a suspect lesion of the oral cavity, the pharynx or larynx and imposes an endoscopy procedure under general anaesthesia (unless it is a lesion of the tonsils or lingual tonsils) - Subjects who have provided consent - Subjects over 18 years old volunteers:- Volunteers - Absence of risk factors cancerous oro-pharyngeal lesions, that is to say, non-smokers, alcohol consumption < 1 glass per day. - Absence of functional oto rhino laryngology symptoms (dyspnoea, dysphagia, dysphonia, pain) - Subjects who have provided consent - Subjects over 18 years old Exclusion Criteria: patient :- Patients without national health insurance cover - Pregnant or breast-feeding women - Biopsies not feasible - because of difficulty of exposure of the tumour - tumour not accessible to the biopsy forceps, - complications during the procedure making it impossible to do the biopsies (difficulties with ventilation) - Spectrometry not feasible - If exposure is difficult, tumour not accessible to the spectrometry probe (for example, a hypopharyngeal tumour in a patient with limited mouth opening) - In cases of anaesthesia complications, such as difficulties with ventilation - Lesions of the tonsils or lingual tonsil, suggesting lymphoma (exclusion of lymphoid tumours) volunteers:- Persons without national health insurance cover - Pregnant or breast-feeding women - Presence of risk factors: alcohol-smoking - Presence of oto rhino laryngology functional symptoms |
| Country | Name | City | State |
|---|---|---|---|
| France | CHU Dijon Bourgogne | Dijon |
| Lead Sponsor | Collaborator |
|---|---|
| Centre Hospitalier Universitaire Dijon |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Reflectance spectrum of haemoglobin | Day one |