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NCT Number: NCT06336941

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

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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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Università di Pisa

Pisa, 56126, Italy

Location status: Recruiting

Location contact

Rossana Izzetti, DS, PhD

CONTACT

[email protected]

+39050993037

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Ultrasound

Device

Ultrasonographic scan with a 70 MHz probe

Primary outcomes

  1. Depth of invasion

    Time frame: measured preoperatively

    Measurement of Depth of invasion on ultrasonography

Study contacts

Contact information is provided by the study sponsor or research team.

Rossana Izzetti, DDS, PhD

CONTACT

[email protected]

+39050993037

Sponsors and collaborators

Lead sponsor

University of Pisa

Other

Registry information

Official study title

Intraoral Ultra-High Frequency Ultrasound of Oral Soft Tissue Lesions

Acronym: HOUSTON

Important dates

Study start
2018
Primary completion
2025
Study completion
2030
First posted
Mar 29, 2024
Registry last updated
Feb 25, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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