Actively Recruiting
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
Eligibility Criteria
You may qualify if you...
- Clinical diagnosis of oral squamous cell carcinoma
- Eligibility for surgical treatment
- Acceptance to be included in the study
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
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
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
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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