Lung CancerARGOSNCT05775068
ARtificial Intelligence for Gross Tumour vOlume Segmentation
An observational study of Lung Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.
Trial summary
Identifying the outline of a Gross Tumour Volume (GTV) in lung cancer is an essential step in radiation treatment. Clinical research, such as radiomics and image-based prognostication, requires the GTV to be pre-defined on massive imaging datasets. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Lung Cancer
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 2,000 participants
- Where
- 1 siteNetherlands
- Study dates
- 1 Jul 2021to 1 Jul 2027
- 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
- No healthy volunteers
- Adult, Older adult
Study population: Retrospectively archive/registry-extracted adult lung cancer patients treated with external beam radiotherapy, having a GTV mass in the lung (not exclusively mediastinal disease) on radiotherapy planning CT, such that a Primary Lung GTV has been delineated by a human expert physician (i.e. radiation oncologist).
Who may be able to join
- Primary lung cancer, either small-cell or non-small cell
- Any stage of primary disease
- Radiotherapy planning Computed Tomography (CT) series taken before the commencement of radiotherapy
- Gross Tumor Volume delineated (see primary outcome above)
- CT series in DICOM format
- Primary GTV delineation (not including respiratory motion) in RT-Structure DICOM format for one matching CT series
- Any type of external beam radiotherapy treatment received
- Combinations with other therapies permitted
Who cannot join
- Not a primary in the lung
- Exclusively nodal disease in mediastinum with no visible hyperintense mass within the outlines of the lung parenchyma
- Only has CT series taken after lung resection
- CT reconstructed pixel spacing (spatial resolution) exceeding 1.1 mm per pixel
- CT reconstructed slice thickness is greater than 3 mm per slice
Trial locations and contacts
1 site in 1 country.
About this study
Identifying the outline of a Gross Tumour Volume (GTV) in lung cancer is an essential step in radiation treatment. Clinical research, such as radiomics and image-based prognostication, requires the GTV to be pre-defined on massive imaging datasets. The ARGOS community creates an open-source and vendor-agnostic federated learning infrastructure that makes it possible to train a deep learning neural network to automatically segment Lung Cancer GTV on computed tomography images. To reduce risks associated with sharing of patient data, we have used a data-secure Federated Learning paradigm known as the "Personal Health Train" that has been jointly developed by MAASTRO Clinic and the Dutch Comprehensive Cancer Organization (IKNL). The successful completion of this project will deliver a highly scalable and readily-reusable framework where multiple clinics anywhere in the world - large or small - can equitably collaborate and solve complex clinical problems with the help of artificial intelligence and massive amounts of data, while reducing the barriers associated with moving sensitive patient data across borders.
Read the detailed description
Lung cancer (LC) is the single leading cancer cause of death worldwide (age-standardized rate of 18.5 per 100,000 population), outstripping the mortality from cancers of the breast, gastro-intestinal tract and reproductive organs. Radiotherapy (RT), often in combination with other treatments, has an essential role in managing LC. An essential step in the RT process is to draw the outline of the Gross Tumor Volume (GTV) in the lung on axial computed tomography (CT) scans. The step is required for precisely directing tumoricidal radiation to the target, and simultaneously avoiding irradiation of adjacent healthy tissue as much as reasonably achievable.
However, tumor outlining by hand consumes a large amount of expert physician time, and has demonstrably high levels of inter- and intra-observer variability. Part of a clinical solution would require validated automated systems that work well for complex GTVs in a wide variety of clinical settings. In recent times, a subclass of artificial intelligence known as deep learning neural networks (DLNNs) has shown promising potential to assist clinicians for such image processing tasks. The immense appeal of DLNN-based tools, if they can be safely shown to add value into radiotherapy clinical workflow, is easily understandable - these have the potential to significantly boost the productivity of clinicians by automating a portion of labor-intensive work.
In respect to LC, models trained on selective data from few institutions are the norm. What the field lacks is not simply large sample size, but sufficient diversity and heterogeneity of subjects to represent the real world, and the means to train a DLNN on such a population. That such a population exists among all the RT clinics around the world is indisputable, however the question is how do we utilize data from all over the world for such a purpose.
"Federated Learning" very clearly addresses this by side-stepping a few of the administrative complication of transferring individual-patient level data across national borders. Federated learning is an implementation of the Personal Health Train (PHT) paradigm, where we send research questions to each other in the form of software and exchange anonymous statistical results (such as a DLNN model) instead of sending patient data around. Hence PHT addresses two of the major challenges of using large-scale cancer data at a single stroke: (a) using data for a good purpose in spite of the geographic dispersion of oncology data, and (b) reducing privacy concerns associated sharing of private patient data across borders.
Objective
Project ARGOS will demonstrate how some of the infrastructural challenges of federated deep learning and early clinical feasibility barriers to an LC GTV DLNN-based automated segmentation model might be developed using a PHT approach. ARGOS adopts a global, cooperative, vendor-agnostic and inter-disciplinary approach to AI development using decentralized imaging datasets. As our first starting step, we will focus on less complex clinical cases where the LC primary GTV is mostly contained inside the lung.
ARGOS plans to use existing radiotherapy planning CT delineations from several leading radiotherapy centres throughout Europe, Asia, Oceania and North America. No new patient data will be required because all the existing data already resides inside RT clinics as a result of standard-of-care treatment.
The initial objective will be to train a DLNN that automatically segments the LC primary GTV that is mostly or entirely contained in the lung parenchyma. The ARGOS partners will also independently validate the globally-trained model on holdout validation and external test datasets.
Sub-objectives
- Share know-how among radiotherapy centres around the world for setting up the required radiotherapy imaging data and metadata as "FAIR imaging data stations".
- Offer a vendor-neutral and platform-agnostic open-source architecture for global federated deep learning ("secure tracks").
- Provide a registration and credentialing procedure for packaging deep learning algorithms as a docker container software application ("docker trains").
- Define a project governance structure and standardized operational principles, including collaborative research agreements, data protection and intellectual property valorization.
- Conditions
- Lung Cancer
- Being tested
- Radiotherapy
- Keywords
- artificial intelligence, deep learning, federated learning, computed tomography, tumor segmentation, radiation dosimetry, treatment planning
- Medical subject headings
- Lung Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
Radiotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
As-treated primary GTV delineation in lung
Gross Tumor Volume as delineated by a medical professional on a treatment planning computed tomography scan for the purpose of radiation planning/dosimetry but not re-drawn/re-edited for this research study.
Measured: Before radiotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Mar 2023
- Study start1 Jul 2021
- Primary completion30 Sep 2023
- Study completion1 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Lung 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
- 2,000 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Maastricht Radiation Oncology
- Sponsor type
- University, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Radboud University Medical Center, The Netherlands Cancer Institute, University Hospital, Basel, Switzerland, University of Zurich, University Medical Center Groningen, Isala, Tianjin Medical University Cancer Institute and Hospital, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Cardiff University, The Leeds Teaching Hospitals NHS Trust, The Christie NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, Hospital Israelita Albert Einstein, University of Pennsylvania, Liverpool Hospital, South Western Sydney Local Health District, MVR Cancer Centre and Research Institute India, H. Lee Moffitt Cancer Center and Research Institute, Oslo University Hospital, Christian Medical College, Vellore, India, Fudan University, Swiss Institute of Bioinformatics, Guangdong Provincial People's Hospital, National Institute of Technology Calicut, Maastricht University
- Responsible party
- Principal investigator, Andre Dekker, Maastricht Radiation Oncology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05775068
- Sponsor's protocol ID
- ARGOS
- Acronym
- ARGOS
- Status last verified
- Oct 2026
- First submitted
- 7 Mar 2023
- Last updated
- 15 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Federated learning does not require transfer of patient data to the leading investigator.
Publications
Choudhury A, Volmer L, Martin F, Fijten R, Wee L, Dekker A, Soest JV. Advancing Privacy-Preserving Health Care Analytics and Implementation of the Personal Health Train: Federated Deep Learning Study. JMIR AI. 2025 Feb 6;4:e60847. doi: 10.2196/60847.
PubMed 39912580
Study at a glance
From the registry record, last updated by the sponsor on 15 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- ARtificial Intelligence for Gross Tumour vOlume Segmentation
- ClinicalTrials.gov ID
- NCT05775068
- Acronym / sponsor ID
- ARGOS / ARGOS
- Conditions
- Lung Cancer
- Keywords
- artificial intelligence, deep learning, federated learning, computed tomography, tumor segmentation, radiation dosimetry, treatment planning
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 2,000 participants (estimated)
- Lead sponsor
- Maastricht Radiation OncologyUniversity, hospital or other
- Collaborators
- Universitaire Ziekenhuizen KU Leuven, Radboud University Medical Center, The Netherlands Cancer Institute, University Hospital, Basel, Switzerland, University of Zurich, University Medical Center Groningen, Isala, Tianjin Medical University Cancer Institute and Hospital, Fondazione Policlinico Universitario Agostino Gemelli IRCCS, Cardiff University, The Leeds Teaching Hospitals NHS Trust, The Christie NHS Foundation Trust, Cambridge University Hospitals NHS Foundation Trust, Hospital Israelita Albert Einstein, University of Pennsylvania, Liverpool Hospital, South Western Sydney Local Health District, MVR Cancer Centre and Research Institute India, H. Lee Moffitt Cancer Center and Research Institute, Oslo University Hospital, Christian Medical College, Vellore, India, Fudan University, Swiss Institute of Bioinformatics, Guangdong Provincial People's Hospital, National Institute of Technology Calicut, Maastricht University
- Study start
- 1 Jul 2021 (actual)
- Primary completion
- 30 Sep 2023 (actual)
- Study completion
- 1 Jul 2027 (estimated)
- First posted
- 20 Mar 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.
Identifying the outline of a Gross Tumour Volume (GTV) in lung cancer is an essential step in radiation treatment. Clinical research, such as radiomics and image-based prognostication, requires the GTV to be pre-defined on massive imaging datasets. The ARGOS community creates an open-source and vendor-agnostic federated learning infrastructure that makes it possible to train a deep learning neural network to automatically segment Lung Cancer GTV on computed tomography images. To reduce risks associated with sharing of patient data, we have used a data-secure Federated Learning paradigm known as the "Personal Health Train" that has been jointly developed by MAASTRO Clinic and the Dutch Comprehensive Cancer Organization (IKNL). The successful completion of this project will deliver a highly scalable and readily-reusable framework where multiple clinics anywhere in the world - large or small - can equitably collaborate and solve complex clinical problems with the help of artificial intelligence and massive amounts of data, while reducing the barriers associated with moving sensitive patient data across borders.
Detailed description
Lung cancer (LC) is the single leading cancer cause of death worldwide (age-standardized rate of 18.5 per 100,000 population), outstripping the mortality from cancers of the breast, gastro-intestinal tract and reproductive organs. Radiotherapy (RT), often in combination with other treatments, has an essential role in managing LC. An essential step in the RT process is to draw the outline of the Gross Tumor Volume (GTV) in the lung on axial computed tomography (CT) scans. The step is required for precisely directing tumoricidal radiation to the target, and simultaneously avoiding irradiation of adjacent healthy tissue as much as reasonably achievable.
However, tumor outlining by hand consumes a large amount of expert physician time, and has demonstrably high levels of inter- and intra-observer variability. Part of a clinical solution would require validated automated systems that work well for complex GTVs in a wide variety of clinical settings. In recent times, a subclass of artificial intelligence known as deep learning neural networks (DLNNs) has shown promising potential to assist clinicians for such image processing tasks. The immense appeal of DLNN-based tools, if they can be safely shown to add value into radiotherapy clinical workflow, is easily understandable - these have the potential to significantly boost the productivity of clinicians by automating a portion of labor-intensive work.
In respect to LC, models trained on selective data from few institutions are the norm. What the field lacks is not simply large sample size, but sufficient diversity and heterogeneity of subjects to represent the real world, and the means to train a DLNN on such a population. That such a population exists among all the RT clinics around the world is indisputable, however the question is how do we utilize data from all over the world for such a purpose.
"Federated Learning" very clearly addresses this by side-stepping a few of the administrative complication of transferring individual-patient level data across national borders. Federated learning is an implementation of the Personal Health Train (PHT) paradigm, where we send research questions to each other in the form of software and exchange anonymous statistical results (such as a DLNN model) instead of sending patient data around. Hence PHT addresses two of the major challenges of using large-scale cancer data at a single stroke: (a) using data for a good purpose in spite of the geographic dispersion of oncology data, and (b) reducing privacy concerns associated sharing of private patient data across borders.
Objective
Project ARGOS will demonstrate how some of the infrastructural challenges of federated deep learning and early clinical feasibility barriers to an LC GTV DLNN-based automated segmentation model might be developed using a PHT approach. ARGOS adopts a global, cooperative, vendor-agnostic and inter-disciplinary approach to AI development using decentralized imaging datasets. As our first starting step, we will focus on less complex clinical cases where the LC primary GTV is mostly contained inside the lung.
ARGOS plans to use existing radiotherapy planning CT delineations from several leading radiotherapy centres throughout Europe, Asia, Oceania and North America. No new patient data will be required because all the existing data already resides inside RT clinics as a result of standard-of-care treatment.
The initial objective will be to train a DLNN that automatically segments the LC primary GTV that is mostly or entirely contained in the lung parenchyma. The ARGOS partners will also independently validate the globally-trained model on holdout validation and external test datasets.
Sub-objectives
- Share know-how among radiotherapy centres around the world for setting up the required radiotherapy imaging data and metadata as "FAIR imaging data stations".
- Offer a vendor-neutral and platform-agnostic open-source architecture for global federated deep learning ("secure tracks").
- Provide a registration and credentialing procedure for packaging deep learning algorithms as a docker container software application ("docker trains").
- Define a project governance structure and standardized operational principles, including collaborative research agreements, data protection and intellectual property valorization.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Retrospectively archive/registry-extracted adult lung cancer patients treated with external beam radiotherapy, having a GTV mass in the lung (not exclusively mediastinal disease) on radiotherapy planning CT, such that a Primary Lung GTV has been delineated by a human expert physician (i.e. radiation oncologist).
Key inclusion criteria (8 listed)
- Primary lung cancer, either small-cell or non-small cell
- Any stage of primary disease
- Radiotherapy planning Computed Tomography (CT) series taken before the commencement of radiotherapy
- Gross Tumor Volume delineated (see primary outcome above)
- CT series in DICOM format
Key exclusion criteria (5 listed)
- Not a primary in the lung
- Exclusively nodal disease in mediastinum with no visible hyperintense mass within the outlines of the lung parenchyma
- Only has CT series taken after lung resection
- CT reconstructed pixel spacing (spatial resolution) exceeding 1.1 mm per pixel
- CT reconstructed slice thickness is greater than 3 mm per slice
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 |
|---|---|---|
| RadiotherapyRadiotherapy | Radiation | – |
Primary outcome
As-treated primary GTV delineation in lung
Time frame: Before radiotherapy
Gross Tumor Volume as delineated by a medical professional on a treatment planning computed tomography scan for the purpose of radiation planning/dosimetry but not re-drawn/re-edited for this research study.
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 15 Oct 2026.
- Derived from this study: PubMed 39912580Choudhury A, Volmer L, Martin F, Fijten R, Wee L, Dekker A, Soest JV. Advancing Privacy-Preserving Health Care Analytics and Implementation of the Personal Health Train: Federated Deep Learning Study. JMIR AI. 2025 Feb 6;4:e60847. doi: 10.2196/60847.
- \[1\] The Personal Health TrainLink provided by the sponsor.
- Individual participant dataSharing planned: No. Federated learning does not require transfer of patient data to the leading investigator.
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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.
The record lists no contact. Use the official record to reach the sponsor.
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 Lung Cancer, run by Maastricht Radiation Oncology at 1 site in Netherlands.
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 8 inclusion and 5 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: under way, not looking for participants, as of the sponsor's last update on 15 Oct 2026. 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 Netherlands. 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?
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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
As-treated primary GTV delineation in lung (time frame: Before radiotherapy). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05775068, which also lists 1 linked publication.
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 15 Oct 2026.