Head and Neck Cancer (H&Amp;Amp;N)VIBRANTNCT07098819
The eValuation of Sources of vIBRAtioN for Vibrational Shear Wave elasTography
An observational study of Head and Neck Cancer (H&Amp;Amp;N) and Lymph Nodes, run by Institute of Cancer Research, United Kingdom.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Head and Neck Cancer (H&Amp;Amp;N), Lymph Nodes
- What is being tested?
- Vibrational Shear wave elastography algorithm
- Type of treatment
- Medical device
- How many people
- 15 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2025to 30 Jul 2026
- How long will I take part?
- 1 Day
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Healthy adult volunteers
Who may be able to join
- Healthy adult volunteers
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
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
- Being tested
- Vibrational Shear wave elastography algorithm
- Keywords
- vibrational shear wave elastography, ultrasound imaging
- Medical subject headings
- Head and Neck Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Vibrational Shear wave elastography algorithmDevice
An algorithm that detects the propogation of shear waves in the head and neck.
| Study group | Role | What they receive |
|---|---|---|
| Healthy volunteers | Not described Receives: Device: Vibrational Shear wave elastography algorithm |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 1
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Aug 2025
- Study start1 Sep 2025 (estimated)
- Primary completion30 Jul 2026 (estimated)
- Study completion30 Jul 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Head and Neck Cancer (H&Amp;Amp;N)Studies of the same condition, open and under way.
- More trials run by Institute of Cancer Research, United KingdomThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 15 participants (estimated)
- Target duration
- 1 Day
Sponsor and investigators
- Lead sponsor
- Institute of Cancer Research, United Kingdom
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07098819
- Sponsor's protocol ID
- CCR5897
- Acronym
- VIBRANT
- Status last verified
- Jul 2025
- First submitted
- 26 Jun 2025
- Last updated
- 1 Aug 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The eValuation of Sources of vIBRAtioN for Vibrational Shear Wave elasTography
- ClinicalTrials.gov ID
- NCT07098819
- Acronym / sponsor ID
- VIBRANT / CCR5897
- Conditions
- Head and Neck Cancer (H&Amp;Amp;N), Lymph Nodes
- Keywords
- vibrational shear wave elastography, ultrasound imaging
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 15 participants (estimated)
- Lead sponsor
- Institute of Cancer Research, United KingdomUniversity, hospital or other
- Study start
- 1 Sep 2025 (estimated)
- Primary completion
- 30 Jul 2026 (estimated)
- Study completion
- 30 Jul 2026 (estimated)
- First posted
- 1 Aug 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 1 Day
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Healthy volunteers | – | Device: Vibrational Shear wave elastography algorithm |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Healthy adult volunteers
Key inclusion criteria (1 listed)
- Healthy adult volunteers
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Vibrational Shear wave elastography algorithmAn algorithm that detects the propogation of shear waves in the head and neck. | Device | Healthy volunteers |
Primary outcome
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2025.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer (H&Amp;Amp;N) and Lymph Nodes, run by Institute of Cancer Research, United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 1 Aug 2025. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Emma Harris, PhD (0203 437 6492, emma.harris@icr.ac.uk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Mean shear wave speed (time frame: Day 1). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Aug 2025.