Actively Recruiting

Phase Not Applicable
Age: 18Years +
All Genders
ID06336941

Intraoral Ultra-High Frequency Ultrasound of Oral Soft Tissue Lesions

Led by University of Pisa · Updated on 2026-02-25

400

Participants Needed

1

Research Sites

260 weeks

Total Duration

On this page

AI-Summary

What this Trial Is About

Researchers are studying oral squamous cell carcinoma to evaluate the use of intraoral ultra-high frequency ultrasonography as a diagnostic tool. The goal is to improve visualization of oral soft tissue lesions beyond the mucosal surface, supporting clinical diagnosis with a minimally invasive, repeatable, and cost-effective imaging method. This study focuses on how this ultrasound technique may help assess tumor characteristics in the mouth. Participants diagnosed with oral squamous cell carcinoma and eligible for surgery will undergo an intraoral ultrasound scan using a 70 MHz frequency probe. This device is designed to measure tumor depth of invasion and thickness before surgery, providing detailed imaging of the oral soft tissues. The study involves only this experimental ultrasound procedure for patients meeting the criteria. During the study, participants will receive the ultrasound scan preoperatively to measure the depth of invasion of their tumor. Researchers will collect this measurement as the primary outcome to assess the ultrasound's diagnostic role. The study includes monitoring for safety and adherence, with participants followed until study completion. The total duration and follow-up specifics depend on each participant's surgical timeline and study protocols.

CONDITIONS

Brief Title

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

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Clinical diagnosis of oral squamous cell carcinoma
  • Eligibility for surgical treatment
  • Acceptance to be included in the study
Not Eligible

You will not qualify if you...

  • 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

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Your Study Journey

Screening

Duration - 2 to 4 weeks

Participants are screened for eligibility to participate in the trial.

1 visit (in-person)

Diagnostic Evaluation

Duration - Up to 1 day before surgery

Participants undergo an intraoral ultrasonographic scan with a 70 MHz frequency probe to evaluate tumor depth of invasion and thickness.

1 visit (in-person)

Trial Site Locations

Total: 1 location

1

Università di Pisa

Pisa, Italy, 56126

Actively Recruiting

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Research Team

R

Rossana Izzetti, DDS, PhD

How is the study designed?

Study Type

INTERVENTIONAL

Masking

NONE

Allocation

NA

Model

SINGLE_GROUP

Primary Purpose

DIAGNOSTIC

Number of Arms

1

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