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

NCT06336941 | Recruiting

• 1 other identifier: 32822
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 1

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.

Conditions

Oral Squamous Cell Carcinoma

Keywords

oral neoplasm; ultrasonography; depth of invasion

Outcome Measures

Primary Outcomes (1)

• Depth of invasion

  Measurement of Depth of invasion on ultrasonography

  measured preoperatively

Study Arms (1)

Ultrasound group

EXPERIMENTAL

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

Device: Ultrasound

Interventions

Ultrasound DEVICE

Ultrasonographic scan with a 70 MHz probe

Ultrasound group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• University of Pisa: lead

Study Sites (1)

Università di Pisa

Pisa, 56126, Italy

RECRUITING

MeSH Terms

Conditions

Squamous Cell Carcinoma of Head and Neck; Mouth Neoplasms

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Carcinoma, Squamous Cell; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Head and Neck Neoplasms; Neoplasms by Site; Mouth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Central Study Contacts

Rossana Izzetti, DDS, PhD

CONTACT

+39050993037; rossana.izzetti@unipi.it

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Researcher at the Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine of the University of Pisa, Principal Investigator

Study Record Dates

• First Submitted: March 21, 2024
• First Posted: March 29, 2024
• Study Start: June 7, 2018
• Primary Completion: December 31, 2025
• Study Completion (Estimated): December 31, 2030
• Last Updated: February 25, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)