Head and Neck CancerHuVeMNCT06035653
A Human Versus Machine Comparison Study
An observational study of Head and Neck Cancer, run by East and North Hertfordshire NHS Trust at 1 site in United Kingdom.
Trial summary
The study aims to retrospectively, and anonymously analyse the data of patients treated over a period of 12 months. These are the patients whose radiotherapy plan were needed to be reviewed in the weekly on-treatment head and neck multi-professional radiotherapy meeting during the course of their radiation. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- How many people
- 40 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 3 Apr 2023to 27 Nov 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
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
- Adult, Older adult
Study population: Minimum of 12 patients who required total radiotherapy replan (Cohort A) Minimum of 28 patients who were reviewed in the multi-professional meeting but did not require full replan (Cohort B) Minimum of 40 patients in total (Cohorts A\&B).
Who may be able to join
- i. Head and neck cancer patients who require new mask for radiotherapy replanning will be included (Cohort A). These patients typically are ones with rapid shrinkage of the nodal disease, or whose weight change is notable (5 - 10% of baseline) in the first 2 weeks of radiotherapy ii. Patients on close observation of the head and neck multi-professional team but whose radiotherapy did no undergo total replan treatment will be included (Cohort B)
Who cannot join
- Patients whose primary malignancy is not of head and neck origin ii. Patients who specifically opt against their information be used anonymously iii. Head and neck cancer patients whose radiotherapy plans did not require review in the head and neck multi-professional radiotherapy meeting iv. Patients under the age of 18
Trial locations and contacts
1 site in 1 country.
United Kingdom1 site, 1 recruiting
- Recruiting
East & North Hertfordshire NHS Trust
Northwood, UK, HA6 2RN
Kevin Chiu, CI, 02038262020, k.chiu@nhs.net
Rishma Bhatti, 02038262020, mvccresearch.enh-tr@nhs.net
About this study
Official title: A Step Towards Fully Automated Adaptive Radiotherapy in Head & Neck Cancer: A Human Versus Machine Comparison Study
The study aims to retrospectively, and anonymously analyse the data of patients treated over a period of 12 months. These are the patients whose radiotherapy plan were needed to be reviewed in the weekly on-treatment head and neck multi-professional radiotherapy meeting during the course of their radiation.
Collected clinical data will be included in the retrospective analysis, comparing the clinical decision (gold standard of care), against the predictive capability of intelligence software
Read the detailed description
This is a single centre, non-interventional study comparing "machine" against clinician's standard of care approach. The utilisation of intelligence software is for research purposes only and does not permit active changes to patients' clinical management. Any software related analyses will be done after patients have completed radiation treatment.
All consented patients who were discussed in the head and neck CBCT meeting and deemed to require new masks / recontouring / replanning - Cohort A will be analysed on completion of radiotherapy. These patients typically are ones with nodal disease of >3cm at presentation, and whose weight change is notable 5 - 10% of baseline in the first 2 weeks of their treatment. There have been 28 patients in 12 months previously.
Other patients discussed in the head and neck CBCT meeting on completion of radiation - Cohort B, whose radiotherapy was not deemed to require total replan but were clinically deemed 'marginal' will be included. These patients tend to be ones with weight loss measuring close to 1.29cm lateral separation or between the skin surface and the head shell.
The radiotherapy replan volumes CTVs of Cohort A patients will retrospectively compared to the CTVs produced by the intelligence software. The time using the software to produce dynamic CTVs will be compared with the time needed for the clinicians to create new CTV for the radiotherapy replan, which will be recorded prospectively.
The CBCTs of both Cohorts A \& B will be analysed using the intelligence software to determine the adequacy of PTV coverage. This is to be compared with the departmental quality assurance/audit of PTV margins.
The software will also be used to calculate various aspects of the radiotherapy plans, including the cumulative dose distribution over the period of dynamic anatomical change Cohorts A \& B.
- Conditions
- Head and Neck Cancer
- 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.
| Study group | Role | What they receive |
|---|---|---|
| A | Minimum of 12 patients who required total radiotherapy replan | |
| B | Minimum of 28 patients who were reviewed in the multi-professional meeting but did not require full replan |
What is being measured
The primary outcome is the main question the study is designed to answer.
Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs
Measured by volume differences
Measured: 1 year
Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs - Sorensen-DICE Coefficient
Measurement of ratio of overlap
Measured: 1 year
Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs - Discordance Index
Measurement of over contouring
Measured: 1 year
Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs - Geographical miss index
Measurement of under contouring
Measured: 1 year
Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs - Hausdorff distance
Measurement of distance between 2 volumes
Measured: 1 year
PTV margins compared against the departmental standards
Proportion of clinical tumour volume covered by different radiotherapy set up margins 3, 4 and 5mm
Measured: 1 year
Secondary outcomes (2)
Potential time saved recontouring with software and the associated cost of re-planning adaptive radiotherapy
Difference between time spent on re- contouring and time spent on editing software deformed CTVs
Measured: 1 year
Evaluation of clinical decision on total radiotherapy re-plan
Measured by retrospective assessment of dose accumulation of the CTVs
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Sep 2023
- Study start3 Apr 2023
- Primary completion27 Nov 2023 (estimated)
- Study completion27 Nov 2023 (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 CancerStudies of the same condition, open and under way.
- 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
- Retrospective
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- East and North Hertfordshire NHS Trust
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06035653
- Sponsor's protocol ID
- RD2021-57
- Acronym
- HuVeM
- Status last verified
- Sep 2023
- First submitted
- 9 May 2023
- Last updated
- 18 Sep 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Sep 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Step Towards Fully Automated Adaptive Radiotherapy in Head & Neck Cancer: A Human Versus Machine Comparison Study
- ClinicalTrials.gov ID
- NCT06035653
- Acronym / sponsor ID
- HuVeM / RD2021-57
- Conditions
- Head and Neck Cancer
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- East and North Hertfordshire NHS TrustOther government
- Study start
- 3 Apr 2023 (actual)
- Primary completion
- 27 Nov 2023 (estimated)
- Study completion
- 27 Nov 2023 (estimated)
- First posted
- 13 Sep 2023 (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.
The study aims to retrospectively, and anonymously analyse the data of patients treated over a period of 12 months. These are the patients whose radiotherapy plan were needed to be reviewed in the weekly on-treatment head and neck multi-professional radiotherapy meeting during the course of their radiation.
Collected clinical data will be included in the retrospective analysis, comparing the clinical decision (gold standard of care), against the predictive capability of intelligence software
Detailed description
This is a single centre, non-interventional study comparing "machine" against clinician's standard of care approach. The utilisation of intelligence software is for research purposes only and does not permit active changes to patients' clinical management. Any software related analyses will be done after patients have completed radiation treatment.
All consented patients who were discussed in the head and neck CBCT meeting and deemed to require new masks / recontouring / replanning - Cohort A will be analysed on completion of radiotherapy. These patients typically are ones with nodal disease of >3cm at presentation, and whose weight change is notable 5 - 10% of baseline in the first 2 weeks of their treatment. There have been 28 patients in 12 months previously.
Other patients discussed in the head and neck CBCT meeting on completion of radiation - Cohort B, whose radiotherapy was not deemed to require total replan but were clinically deemed 'marginal' will be included. These patients tend to be ones with weight loss measuring close to 1.29cm lateral separation or between the skin surface and the head shell.
The radiotherapy replan volumes CTVs of Cohort A patients will retrospectively compared to the CTVs produced by the intelligence software. The time using the software to produce dynamic CTVs will be compared with the time needed for the clinicians to create new CTV for the radiotherapy replan, which will be recorded prospectively.
The CBCTs of both Cohorts A \& B will be analysed using the intelligence software to determine the adequacy of PTV coverage. This is to be compared with the departmental quality assurance/audit of PTV margins.
The software will also be used to calculate various aspects of the radiotherapy plans, including the cumulative dose distribution over the period of dynamic anatomical change Cohorts A \& B.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A | – | –Minimum of 12 patients who required total radiotherapy replan |
| B | – | –Minimum of 28 patients who were reviewed in the multi-professional meeting but did not require full replan |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Age groups
- Adult, Older adult
- Study population
- Minimum of 12 patients who required total radiotherapy replan (Cohort A) Minimum of 28 patients who were reviewed in the multi-professional meeting but did not require full replan (Cohort B) Minimum of 40 patients in total (Cohorts A\&B).
Key inclusion criteria (1 listed)
- i. Head and neck cancer patients who require new mask for radiotherapy replanning will be included (Cohort A). These patients typically are ones with rapid shrinkage of the nodal disease, or whose weight change is notable (5 - 10% of baseline) in the first 2 weeks of radiotherapy ii. Patients on close observation of the head and neck multi-professional team but whose radiotherapy did no undergo total replan treatment will be included (Cohort B)
Key exclusion criteria (1 listed)
- Patients whose primary malignancy is not of head and neck origin ii. Patients who specifically opt against their information be used anonymously iii. Head and neck cancer patients whose radiotherapy plans did not require review in the head and neck multi-professional radiotherapy meeting iv. Patients under the age of 18
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs
Time frame: 1 year
Measured by volume differences
Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs - Sorensen-DICE Coefficient
Time frame: 1 year
Measurement of ratio of overlap
Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs - Discordance Index
Time frame: 1 year
Measurement of over contouring
Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs - Geographical miss index
Time frame: 1 year
Measurement of under contouring
Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs - Hausdorff distance
Time frame: 1 year
Measurement of distance between 2 volumes
PTV margins compared against the departmental standards
Time frame: 1 year
Proportion of clinical tumour volume covered by different radiotherapy set up margins 3, 4 and 5mm
2 secondary outcomes
Potential time saved recontouring with software and the associated cost of re-planning adaptive radiotherapy
Time frame: 1 year
Evaluation of clinical decision on total radiotherapy re-plan
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Sep 2023.
- Individual participant dataSharing planned: No
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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. This study is not recruiting at the moment.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Head and Neck Cancer, run by East and North Hertfordshire NHS Trust at 1 site in 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 1 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: status not confirmed, as of the sponsor's last update on 18 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Kevin Chiu (0203 826 2020, k.chiu@nhs.net), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs (time frame: 1 year). The study lists 6 primary outcomes in all. 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 18 Sep 2023.