- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05653063
ARCHERY - Artificial Intelligence Based Radiotherapy Treatment Planning for Cervical, Head and Neck and Prostate Cancer
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.
The 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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
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Kolkata, India
- TATA Medical Centre
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Mumbai, India
- Tata Memorial Hospital
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Amman, Jordan
- King Hussein Cancer Center
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Kuala Lumpur, Malaysia
- University of Malaya Medical Center
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Cape Town, South Africa
- Groote Schuur Hospital
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Stellenbosch, South Africa
- Tygerberg Hospital
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Sampling Method
Study Population
Description
Inclusion Criteria:
- Consecutive patients with histologically confirmed head and neck cancers of the oropharynx, larynx, hypopharynx and nasopharynx (Stage I-III) that have given consent for radical radiotherapy.
- Consecutive histologically confirmed primary cervical cancer patients (Stage IB-IIIB including pelvic node positive) that have given consent for radical radiotherapy.
- Consecutive histologically confirmed primary prostate cancer patients (T1-4N0M0) that have given consent for radical radiotherapy.
- Mental capacity to understand and consent to participate in the study.
- Patients aged ≥18years.
Exclusion Criteria:
- Patients requiring radiotherapy after curative surgery or surgery that is intended to remove as much of the tumour as possible.
- Patients receiving palliative radiotherapy
- Patients aged < 18years.
Study Plan
How is the study designed?
Design Details
- Observational Models: Cohort
- Time Perspectives: Prospective
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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Proportion of radiotherapy treatment plans that have contours and dosimetry that meet pre-defined criteria for clinical acceptability
Time Frame: Prior to first treatment
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Prior to first treatment
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Secondary Outcome Measures
Outcome Measure |
Time Frame |
|---|---|
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comparison of time and human resource requirements between producing automated radiotherapy treatment plans using artificial intelligence and producing treatment plans using the standard manual pathway
Time Frame: radiotherapy plan preparation process pre treatment
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radiotherapy plan preparation process pre treatment
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Comparison of radiotherapy treatment costs using the artificial intelligence automated pathway and standard manual planning pathway
Time Frame: radiotherapy treatment plan preparation process and treatment interval
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radiotherapy treatment plan preparation process and treatment interval
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Collaborators and Investigators
Sponsor
Collaborators
Publications and helpful links
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Estimated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Urogenital Diseases
- Genital Diseases
- Genital Neoplasms, Male
- Urogenital Neoplasms
- Neoplasms by Site
- Neoplasms
- Genital Diseases, Male
- Prostatic Diseases
- Male Urogenital Diseases
- Female Urogenital Diseases
- Female Urogenital Diseases and Pregnancy Complications
- Uterine Diseases
- Genital Diseases, Female
- Genital Neoplasms, Female
- Uterine Cervical Diseases
- Uterine Neoplasms
- Prostatic Neoplasms
- Uterine Cervical Neoplasms
- Head and Neck Neoplasms
Other Study ID Numbers
- ARCHERY (San Raffaele Hospital)
- 1U01CA269143-01 (U.S. NIH Grant/Contract)
- 10678756 (Other Identifier: ISRCTN)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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