The eValuation of Sources of vIBRAtioN for Vibrational Shear Wave elasTography

NCT07098819 | Not Yet Recruiting

• 1 other identifier: CCR5897
• Study Type: observational
• Target: 15
• Locations: 0 countries
• Sites: N/A

Brief Summary

Patients suffering with Head and Neck Cancer often must wait 3 months or more to know if their treatment has been effective, which can be very stressful. The investigators are developing an imaging tool that may be useful to help clinicians understand if patients need secondary treatment, surgery to remove lymph nodes in the neck, sooner. Evidence suggests that lymph nodes containing cancer are stiffer than normal lymph nodes. The investigator's tool, vibrational shear wave elastography, measures the stiffness of tissue using shear waves. Gentle vibrations, like those of a mobile phone, applied to the skin surface can create shear waves in the body. The investigators use ultrasound imaging and an algorithm the investigators have developed to measure shear wave speed which is related to tissue stiffness. The algorithm is applied to ultrasound images using software we have written. To help develop the software the investigators wish to explore different ways of creating shear waves in the neck and see how well the investigators can detect shear waves as they pass through tissues such as muscle, the thyroid and other glands in the neck. The investigators will recruit healthy volunteers to participate in this study. The investigators will use external vibrational sources gently placed against the neck in different positions to understand what the best approach to achieve the best measurement of tissue stiffness is. The investigators will also ask healthy volunteers to generate vibrations themselves using their vocal cords, a process called vocal fremitus. Participants will be asked utter 'aaa' sounds at different pitches, and the investigators will image the shear wave generated by the vibrating vocal cords. The investigators will also ask volunteers how comfortable they found the external vibrations and how easy or difficult they found it to utter and hold the sounds. This study is an exploratory benchmarking study of the software that will help the investigators develop our technique further, and design and build optimal equipment before testing it in patients.

Conditions

Head and Neck Cancer (H&Amp;Amp;N); Lymph Nodes

Keywords

vibrational shear wave elastography; ultrasound imaging

Outcome Measures

Primary Outcomes (1)

• Mean shear wave speed

  Mean shear wave speed in neck tissues (thyroid gland, submandibular gland, parotid, or superficial cervical lymph nodes, adipose tissue, muscle, and cartilage) measured using VSWE software, acquired using external sources.

  Day 1

Study Arms (1)

Healthy volunteers

Device: Vibrational Shear wave elastography algorithm

Interventions

Vibrational Shear wave elastography algorithm DEVICE

An algorithm that detects the propogation of shear waves in the head and neck.

Healthy volunteers

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Healthy adult volunteers

You may qualify if:

• Healthy adult volunteers

You may not qualify if:

• Healthy volunteers who do not consider themselves to currently have normal neck mobility and feel able to lie supine with their neck supported for up to 90 minutes.
• Volunteers who are receiving treatment for diseases of the thyroid, glands, or lymph nodes.

Sponsors & Collaborators

• Institute of Cancer Research, United Kingdom: lead

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms

Central Study Contacts

Emma Harris, PhD

CONTACT

0203 437 6492; emma.harris@icr.ac.uk

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 1 Day
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: June 26, 2025
• First Posted: August 1, 2025
• Study Start: September 1, 2025
• Primary Completion (Estimated): July 30, 2026
• Study Completion (Estimated): July 30, 2026
• Last Updated: August 1, 2025

Record last verified: 2025-07