"Ultra-High Frequency intraOral UltraSonography of the TONgue" (HOUSTON)

University of Pisa

Status: Enrolling

Conditions: Oral Squamous Cell Carcinoma

Treatments: Device: Ultrasound

Study type: Interventional

Funder types: Other

Identifiers

NCT06336941

32822

Details and patient eligibility

About

Oral diseases are currently diagnosed by means of clinical examination and supported by surgical biopsy procedures. In particular, daily oral medicine practice is lacking the use of a routine diagnostic support to the visualization of anatomical structures located beyond the mucosal surface. Considering the growing interest in minimally invasive diagnosis, the possibility of having an imaging technique dedicated to the investigation of oral soft tissues and their alterations may be instrumental to support the clinical diagnosis. Therefore, attempts to introduce conventional ultrasonography (US) to the diagnostic work-up of pathological conditions of the head and neck have been done, exploiting the unique features of this technique in terms of limited invasive- ness, repeatability, and cost efficiency.

In the literature, both extraoral and intraoral applications of US have been reported. Extraoral applications mainly focus on the characterization of oral and maxillofacial swellings of various origin, while intraoral applications mostly involve the study of malignant lesions in terms of tumor thickness and depth of invasion. The aim of the present protocol is to evaluate the role of intraoral ultra-high frequency ultrasonography in the study of oral mucosal lesions.

Enrollment: 400 estimated patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Clinical diagnosis of oral squamous cell carcinoma
• Eligibility for surgical treatment
• Acceptance to be included in the study

Exclusion criteria

• Oral lesions other than oral squamous cell carcinoma
• Pregnant or breastfeeding patients
• Uncontrolled chronic diseases and/or conditions hindering the participation in the study
• Denial of inclusion in the study

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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400 participants in 1 patient group

Ultrasound group

Experimental group

Description:

The patients with a clinical diagnosis of oral squamous cell carcinoma will undergo intraoral ultrasonographic scan with a 70 MHz frequency probe to evaluate tumor depth of invasion and thickness

Treatment:

Device: Ultrasound