A Human Versus Machine Comparison Study (HuVeM)

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

Study Overview

• Status: Recruiting
• Conditions: Head and Neck Cancer

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 Type: Observational
• Enrollment (Estimated): 40

Contacts and Locations

• Study Contact: Name: Kevin Chiu; Phone Number: 0203 826 2020; Email: k.chiu@nhs.net
• Study Contact Backup: Name: Rishma Bhatti; Phone Number: 0203 826 2020; Email: mvccresearch.enh-tr@nhs.net

Study Locations

• United Kingdom
  • UK
    • Northwood, UK, United Kingdom, HA6 2RN
      • Recruiting
      • East & North Hertfordshire NHS Trust
      • Contact: Kevin Chiu, CI; Phone Number: 02038262020; Email: k.chiu@nhs.net
      • Contact: Rishma Bhatti; Phone Number: 02038262020; Email: mvccresearch.enh-tr@nhs.net

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: N/A

• Sampling Method: Non-Probability Sample

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).

Description

Inclusion Criteria:

• 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)

Exclusion Criteria:

i. 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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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 the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs	Measured by volume differences	1 year
Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs - Sorensen-DICE Coefficient	Measurement of ratio of overlap	1 year
Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs - Discordance Index	Measurement of over contouring	1 year
Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs - Geographical miss index	Measurement of under contouring	1 year
Interobserver variability studies (IOV) between manually contoured CTVs and software-generated deformed CTVs - Hausdorff distance	Measurement of distance between 2 volumes	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	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year
Evaluation of clinical decision on total radiotherapy re-plan	Measured by retrospective assessment of dose accumulation of the CTVs	1 year

Collaborators and Investigators

• Sponsor: East and North Hertfordshire NHS Trust

Study record dates

Study Major Dates

• Study Start (Actual): April 3, 2023
• Primary Completion (Estimated): November 27, 2023
• Study Completion (Estimated): November 27, 2023

Study Registration Dates

• First Submitted: May 9, 2023
• First Submitted That Met QC Criteria: September 11, 2023
• First Posted (Actual): September 13, 2023

Study Record Updates

• Last Update Posted (Actual): September 18, 2023
• Last Update Submitted That Met QC Criteria: September 15, 2023
• Last Verified: September 1, 2023

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Site; Head and Neck Neoplasms
• Other Study ID Numbers: RD2021-57

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No