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

Not Applicable

Recruiting

• Conditions: Oral Squamous Cell Carcinoma
• Interventions: Device: Ultrasound

• Registration Number: NCT06336941
• Lead Sponsor: University of Pisa

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2018-06-07
• Study First Submitted: 2024-03-21
• Study First Submitted QC: 2024-03-21
• Study First Posted: 2024-03-29
• Status Verified: 2024-06
• Last Update Submitted: 2024-06-24
• Last Update Posted: 2024-06-26
• Primary Completion: 2025-12-31
• Study Completion: 2030-12-31

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 400

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Ultrasound group	Ultrasound	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

Primary Outcome Measures

Name	Time	Method
Depth of invasion	measured preoperatively	Measurement of Depth of invasion on ultrasonography

Trial Locations

Locations (1)

Università di Pisa; 🇮🇹 Pisa, Italy