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

Intraoral Ultra-High Frequency Ultrasound of Oral Soft Tissue Lesions

Status
Recruiting
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06336941
Acronym
HOUSTON
Enrollment
400
Registered
2024-03-29
Start date
2018-06-07
Completion date
2030-12-31
Last updated
2026-02-25

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Oral Squamous Cell Carcinoma

Keywords

oral neoplasm, ultrasonography, depth of invasion

Brief 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.

Interventions

DEVICEUltrasound

Ultrasonographic scan with a 70 MHz probe

Sponsors

University of Pisa
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Depth of invasionmeasured preoperativelyMeasurement of Depth of invasion on ultrasonography

Countries

Italy

Contacts

CONTACTRossana Izzetti, DDS, PhD
rossana.izzetti@unipi.it+39050993037

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 27, 2026