Evaluation of an artificial intelligence tool to automate radiotherapy treatment
| ISRCTN | ISRCTN10678756 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN10678756 |
| ClinicalTrials.gov number | NCT05653063 |
| Secondary identifying numbers | AI01 |
- Submission date
- 30/06/2022
- Registration date
- 22/09/2022
- Last edited
- 22/05/2024
- Recruitment status
- Recruiting
- Overall study status
- Ongoing
- Condition category
- Cancer
Plain English Summary
Background and study aims
The aim of this study is to look at whether an Artificial Intelligence (AI) based computer program can automate two components of the radiotherapy treatment pathway to a sufficient quality standard to enable its routine clinical use. The two components include the delineation (outlining) of anatomical areas that are at risk of tumour spread and at risk of radiation damage, and the definition of the position, size and shape of the radiation beams.
AI-based computer programs have been developed to perform tasks that would normally require direct human involvement by oncologists and medical physicists. Proposed advantages include improved treatment accuracy, as well as a reduction in the time (from weeks to minutes) and human resources needed to deliver radiotherapy, which this study will test.
Who can participate?
Patients aged 18 years and over with a new diagnosis of head and neck cancers, cervical cancer or prostate cancer that will be treated with radiotherapy.
What does the study involve?
The researchers will use the images from radiotherapy planning CT scan for the study. Following consent for the study, no further information is required from patients.
What are the possible benefits and risks of participating?
There are no expected risks as participants will be treated according to the standard treatment plan with no additional tests or treatment required. There is no immediate benefit for participants in this study as they will be treated according to the current standard. It is hoped that the information from this study will help to improve treatment for future patients with cancer.
Where is the study run from?
MRC CTU at UCL (UK)
When is the study starting and how long is it expected to run for?
June 2021 to September 2026
Who is funding the study?
1. National Institutes of Health (NIH) (USA)
2. Rising Tide Foundation for Clinical Cancer Research (Switzerland)
Who is the main contact?
Dr Ajay Aggarwal, mrcctu.archery@ucl.ac.uk
Contact information
Principal Investigator
MRC CTU at UCL
90 High Holborn
London
WC1V 6LJ
United Kingdom
| Phone | +44 (0)20 7670 4700 |
|---|---|
| mrcctu.archery@ucl.ac.uk |
Study information
| Study design | Prospective observational cohort study |
|---|---|
| Primary study design | Observational |
| Secondary study design | Cohort study |
| Study setting(s) | Hospital |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use contact details to request a participant information sheet |
| Scientific title | ARCHERY - A prospective observational study of artificial intelligence based radiotherapy treatment planning for cervical, head and neck, and prostate cancer |
| Study acronym | ARCHERY |
| Study hypothesis | Current study hypothesis as of 22/05/2024: AI can automate target volume contouring and produce radiotherapy plans that are able to meet international standards for treatment quality Previous study hypothesis: AI can automate target volume delineation and produce radiotherapy plans that are able to meet international standards for treatment quality |
| Ethics approval(s) | Approved 25/04/2023, University College London Research Ethics Committee (Research Ethics Team, Office of the Vice-Provost (Research), University College London, 2 Taviton Street, London, WC1H 0BT, United Kingdom; N/A; ethics@ucl.ac.uk), ref: 24627.001 |
| Condition | Cervical, head and neck, and prostate cancer |
| Intervention | A web-based artificial intelligence (AI) auto-planning tool The CT scan taken at the time of treatment planning is uploaded to a web server called the Radiotherapy planning assistant which automates the contouring of target organs and areas of high-risk disease as well as defining the size, shape and number of radiotherapy beams to treat the cancer. The final plan is downloaded to the local treatment planning system where the doses are recalculated and clinical peer review is undertaken before the plan can be used clinically. In this study patients will not be treated with the AI tool but the manual plan created by the local teams. As the participants will not be receiving the intervention, there will be no follow-up for participants. |
| Intervention type | Other |
| Primary outcome measure | Overall acceptability of the automated treatment plan. This is a composite outcome including both the assessment of the delineated clinical target volumes (CTVs) and organs-at-risk (OARs) using a pre-defined scale and the adherence to acceptable dosimetric constraints for each tumour type. Timepoint: clinical peer review. |
| Secondary outcome measures | 1. Time and resource savings measured during manual and automated processes: 1.1. Date/time CT planning scan performed 1.2. Date/time of delineation started/completed (grade and number of staff members) 1.3. Date/time of radiotherapy treatment planning completed (grade and number of staff members involved) 1.4. Date/time CT (with gross tumor volume [GTV] contoured manually) sent for autcontouring and planning 1.5. Date/time autocontouring and planning completed 2. Cost-effectiveness measured using time-driven activity-based costing tool based on timing and resource use inputs Timepoint: clinical peer review |
| Overall study start date | 01/06/2021 |
| Overall study end date | 01/09/2026 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Lower age limit | 18 Years |
| Sex | Both |
| Target number of participants | 330 for cervical cancer; 330 for head and neck cancer; 330 for prostate cancer |
| Participant inclusion criteria | Current inclusion criteria as of 22/05/2024: 1. Patients with: 1.1. Histologically confirmed head and neck cancers of the oropharynx, larynx, hypopharynx, and nasopharynx (American Joint Committee on Cancer [AJCC] Stage I-IVB) that have given consent for radical radiotherapy. Patients can be included if they have had induction chemotherapy prior to radiotherapy OR 1.2. Histologically confirmed primary cervical cancer (International Federation of Gynaecology and Obstetrics [FIGO]/AJCC Stage IB-IIIC1) that have given consent for radical radiotherapy OR 1.3. Histologically confirmed primary prostate cancer (AJCC Stage I-IIIC) that have given consent for radical radiotherapy 2. Provide signed informed consent to participate in the study 3. Aged ≥18 years Previous inclusion criteria: 1. Consecutive patients at each participating centre with histologically confirmed head and neck cancers of the oropharynx, larynx, hypopharynx and nasopharynx (Stage I-III) that have given consent for primary curative radiotherapy 2. Consecutive histologically confirmed primary cervical cancer patients (Stage IB-IIIB including pelvic node positive) that have given consent for radical radiotherapy 3. Patients aged over 18 years 4. Written informed consent to participate in the study |
| Participant exclusion criteria | Current exclusion criteria as of 22/05/2024: 1. Patients requiring radiotherapy after curative surgery or surgery that is intended to remove as much of the tumour as possible 2. Patients receiving palliative radiotherapy Previous exclusion criteria: 1. Patients requiring radiotherapy after curative or de-bulking surgery |
| Recruitment start date | 27/12/2023 |
| Recruitment end date | 01/12/2025 |
Locations
Countries of recruitment
- India
- Jordan
- Malaysia
- South Africa
Study participating centres
Kuala Lumpur
59100
Malaysia
Amman
11733
Jordan
Stellenbosch Central
Stellenbosch
7600
South Africa
Observatory
Cape Town
7935
South Africa
Parel
Mumbai
400012
India
DH Block (Newtown)
Action Area I
Newtown
Kolkata
700160
India
Sponsor information
University/education
MRC CTU at UCL
90 High Holborn
London
WC1V 6LJ
England
United Kingdom
| Phone | +44 (0)20 7670 4700 |
|---|---|
| mrcctu.ctuenquiries@ucl.ac.uk | |
| Website | https://www.mrcctu.ucl.ac.uk/ |
"ROR" |
https://ror.org/02jx3x895 |
Funders
Funder type
Government
Government organisation / National government
- Alternative name(s)
- Institutos Nacionales de la Salud, US National Institutes of Health, NIH
- Location
- United States of America
Private sector organisation / Trusts, charities, foundations (both public and private)
- Alternative name(s)
- RTFCCR
- Location
- Switzerland
Results and Publications
| Intention to publish date | 01/09/2026 |
|---|---|
| Individual participant data (IPD) Intention to share | Yes |
| IPD sharing plan summary | Available on request |
| Publication and dissemination plan | Planned publications in high-impact peer-reviewed journals |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are/will be available upon request from Dr Ajay Aggarwal (mrcctu.archery@ucl.ac.uk). Data will be shared according to the MRC CTU and UCL’s controlled access approach, based on the following principles: 1. No data should be released that would compromise an ongoing trial or study. 2. There must be a strong scientific or other legitimate rationale for the data to be used for the requested purpose. 3. Investigators who have invested time and effort into developing a trial or study should have a period of exclusivity in which to pursue their aims with the data, before key trial data are made available to other researchers. 4. The resources required to process requests should not be under-estimated, particularly successful requests which lead to preparing data for release. Therefore adequate resources must be available in order to comply in a timely manner or at all, and the scientific aims of the study must justify the use of such resources. 5. Data exchange complies with Information Governance and Data Security Policies in all of the relevant countries. Applications for data can be made at any time and will be considered on a case-by-case basis. Researchers wishing to access ARCHERY data should contact the Trial Management Group in the first instance. Following approval of a request, a formal agreement will be drawn up between the relevant parties prior to the release of any data, and measures will be put in place to ensure that ethical and regulatory requirements relating to data confidentiality are upheld. |
Editorial Notes
22/05/2024: The following changes were made to the study record:
1. The scientific title was changed from 'ARCHERY - Artificial Intelligence based radiotherapy treatment planning for Cervical and Head and Neck cancer' to 'ARCHERY - A prospective observational study of artificial intelligence based radiotherapy treatment planning for cervical, head and neck, and prostate cancer'.
2. ClinicalTrials.gov, ethics approval details and study website added.
3. The study hypothesis, inclusion and exclusion criteria and study participating centres addresses were updated.
4. The condition was changed from 'Cervical and head and neck cancer' to 'Cervical, head and neck, and prostate cancer'.
5. The target number of participants was changed from '353 for cervical cancer; 353 for head and neck cancer' to '330 for cervical cancer; 330 for head and neck cancer; 330 for prostate cancer'.
6. The recruitment start date was changed from 01/03/2023 to 27/12/2023.
7. The recruitment end date was changed from 01/03/2025 to 01/12/2025.
23/03/2023: Internal review.
29/07/2022: Trial's existence confirmed by the Rising Tide Foundation for Clinical Cancer Research.
