"Ultra-High Frequency intraOral UltraSonography of the TONgue" (HOUSTON)
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Ultrasound.
- Who it may be relevant to
- Registry conditions: Oral Squamous Cell Carcinoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Intraoral Ultra-High Frequency Ultrasound of Oral Soft Tissue Lesions
Overview
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
- Device Ultrasound
Ultrasonographic scan with a 70 MHz probe
Primary outcome measures
- Depth of invasion [Time frame: measured preoperatively]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Diagnostic
Study locations
Italy · 1 center
- Università di Pisa — Pisa
Identifiers
NCT: NCT06336941 · 32822