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

Oral Squamous Cell Carcinoma Clinical Trial

— HOUSTON  

Official title:

Intraoral Ultra-High Frequency Ultrasound of Oral Soft Tissue Lesions

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT06336941
• Other study ID #: 32822
• Status: Recruiting
• Phase: N/A
• Start date: June 7, 2018
• Est. completion date: December 31, 2030

Study information

• Verified date: March 2024
• Source: University of Pisa
• Contact: Rossana Izzetti, DDS, PhD
• Phone: +39050993037
• Email: rossana.izzetti[@]unipi.it
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: December 31, 2030
• Est. primary completion date: December 31, 2025
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Oral Squamous Cell Carcinoma
• Squamous Cell Carcinoma of Head and Neck

Intervention

Device:
• Ultrasound
Ultrasonographic scan with a 70 MHz probe

Locations

Country	Name	City	State
Italy	Università di Pisa	Pisa

Sponsors (1)

Lead Sponsor	Collaborator
University of Pisa

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depth of invasion	Measurement of Depth of invasion on ultrasonography	measured preoperatively