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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

400 participants

Study Classification

INTERVENTIONAL

Study Start Date

2018-06-07

Study Completion Date

2030-12-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Oral Squamous Cell Carcinoma

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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Ultrasound group

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

Group Type EXPERIMENTAL

Ultrasound

Intervention Type DEVICE

Ultrasonographic scan with a 70 MHz probe

Interventions

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Ultrasound

Ultrasonographic scan with a 70 MHz probe

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Responsible Party

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Rossana Izzetti

Researcher at the Department of Surgical, Medical and Molecular Pathology and Critical Care Medicine of the University of Pisa, Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR