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

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

NCT ID: NCT06336941

Condition: Oral Squamous Cell Carcinoma

Conditions: Official terms:
Squamous Cell Carcinoma of Head and Neck

Conditions: Keywords:
oral neoplasm
ultrasonography
depth of invasion

Study type: Interventional

Study phase: N/A

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Diagnostic

Masking: None (Open Label)

Intervention:

Intervention type: Device
Intervention name: Ultrasound
Description: Ultrasonographic scan with a 70 MHz probe
Arm group label: Ultrasound group

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.

Criteria for eligibility:
Criteria:
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

Gender: All

Minimum age: 18 Years

Maximum age: N/A

Healthy volunteers: No

Locations:

Facility:
Name: Università di Pisa

Address:
City: Pisa
Zip: 56126
Country: Italy

Status: Recruiting

Contact:
Last name: Rossana Izzetti, DS, PhD

Phone: +39050993037
Email: rossana.izzetti@unipi.it

Start date: June 7, 2018

Completion date: December 31, 2030

Lead sponsor:
Agency: University of Pisa
Agency class: Other

Source: University of Pisa

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT06336941