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NCT Number: NCT07098819

The eValuation of Sources of vIBRAtioN for Vibrational Shear Wave elasTography

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy adult volunteers

Exclusion criteria

  • 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.

Treatment and study plan

Vibrational Shear wave elastography algorithm

Device

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

Primary outcomes

  1. Mean shear wave speed

    Time frame: Day 1

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Emma Harris, PhD

CONTACT

[email protected]

0203 437 6492

Sponsors and collaborators

Lead sponsor

Institute of Cancer Research, United Kingdom

Other

Registry information

Acronym: VIBRANT

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Aug 1, 2025
Registry last updated
Aug 1, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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