Head and Neck CancerRadiomicArtNCT05081531
AI for Head Neck Cancer Treated With Adaptive RadioTherapy (RadiomicART)
A study testing Adaptive Radiotherapy in people with Head and Neck Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.
Trial summary
Current clinical management algorithms for squamous cell carcinoma of head and neck (HNSCC) involve the use of surgery and / or radiotherapy (RT) depending on the stage of the disease at diagnosis. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Head and Neck Cancer
- What is being tested?
- Adaptive Radiotherapy
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 50 participants
- Where
- 1 siteItaly
- Study dates
- 5 Oct 2021to 31 May 2026
- Phase
- Interventional
- 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
Who may be able to join
- ECOG Performance status 0 to 2
- Life expectancy > 12 months
- Histological proven squamous cell carcinoma of the pharynx, larynx or oral cavity
- Locally advanced stage disease classified as T3-T4 or N1-3
- Radical radiotherapy +/- chemotherapy indicated as the primary treatment modality
- Visible disease at the primary site on imaging performed within 4 weeks of starting treatment
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- Adequate liver function
- Adequate renal function for infusion of iv. contrast for CT-scan and MRI-scan
- Adequate bone marrow function
- Written informed consent
- No previous radiation therapy on head and neck region
Who cannot join
- Inability to provide informed consent
- Presence of distant metastases
- Previous radiation therapy on head and neck region
- Pregnant or breastfeeding patients
- Prior malignancy within the last five years (except adequately treated basal cell carcinoma of the skin or in situ carcinoma of the skin or in situ carcinoma of the cervix, surgically cured, or localized prostate cancer without evidence of biochemical progression)
- Mental conditions rendering the patient incapable to understand the nature, scope, and consequences of the study
Show all 9Show fewer
- Allergy or contraindication to contrast agents
- General contraindications to MRI
- ECOG PS >=3
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Artificial Intelligence for Locally Advanced Head Neck Cancer Treated With Multi-modality Adaptive RadioTherapy: Machine Learning-based Radiomic Prediction of Outcome and Toxicity (RadiomicART)
Current clinical management algorithms for squamous cell carcinoma of head and neck (HNSCC) involve the use of surgery and / or radiotherapy (RT) depending on the stage of the disease at diagnosis. Radical RT, exclusive or in combination with systemic therapy, represents an effective therapeutic option according to the international guidelines. Despite the recent technological advancements in the field of RT, about 30-50% of patients will develop locoregional failure after primary treatment . Moreover, although the development of Intensity modulated radiation therapy (IMRT) and Volumetric modulated arc therapy (VMAT) techniques allowed a greater sparing of dose on healthy tissues, radiation-induced toxicity still represents a relevant concern, impacting on quality of life. The continuous effort of personalized medicine has the goal of improving patient's outcome, in terms of both disease's control and pattern of toxicity. Advanced imaging modalities appear to play an essential role in the customization of the radiation treatment as shown through the use of Adaptive Radiotherapy (ART) and radiomic. With ART we mean the adaptation of tumor volumes and surrounding organs at risk (OARs) to the shrinkage and patient emaciation during RT treatment. Adaptive radiotherapy (ART) includes techniques that allow knowledge of patient-specific anatomical variations informed by Image-guided radiotherapies (IGRTs) to feedback into the plan and dose-delivery optimization during the treatment course. Radiomic is the extraction of quantitative features from medical images to characterize tumor pathology or heterogeneity. Radiomic features extracted from medical images can be used as input features to create a machine learning model able to predict survival, and to guide treatment thanks to its predictive value in view of therapy personalization.
The combination of both ART and radiomic analysis could potentially be considered a further advance in the personalization of oncological treatments, and in particular for radiation treatments. For this reason, the investigators designed the present research project with the aim to prospectively evaluate a machine learning-based radiomic approach to predict outcome and toxicity of HNSCC patients treated with ART by mean of CT, MRI and PET-scan.
Read the detailed description
Squamous cell carcinoma of the head and neck (HNSCC) is characterized by an incidence in Europe of 140.000 new cases per year, with survival rates at 5 years ranging from 25 to 65%.
Current clinical management algorithms for HNSCC patients involve the use of surgery and / or radiotherapy depending on the stage of the disease at diagnosis. Radical radiotherapy (RT), exclusive or in combination with systemic therapy, represents an effective therapeutic option according to the international guidelines.
Despite the recent technological advancements in the field of radiation therapy, about 30-50% of patients will develop locoregional failure after primary treatment of head and neck cancer. Moreover, although the development of Intensity modulated radiation therapy (IMRT) and Volumetric modulated arc therapy (VMAT) techniques allowed a greater sparing of dose on healthy tissues, radiation-induced toxicity still represents a relevant concern, impacting on quality of life of cancer patients even for long time after treatment.
The continuous effort of personalized medicine has the goal of improving patient's outcome, in terms of both disease's control and pattern of toxicity. Advanced imaging modalities appear to play an essential role in the customization of the radiation treatment as shown through the use of Adaptive Radiotherapy (ART) and radiomic.
With ART the investigators mean the adaptation of tumor volumes and surrounding organs at risk (OARs) to the shrinkage and patient emaciation during RT treatment.
The recent literature showed that tumor shrinkage can reach 70% by the end of the RT treatment, and at the same time OARs, such as parotid glands, can reduce their size by 7 to 70%. These alterations, if not taken into account, can lead to an unexpected delivery of lower dose on the tumor and higher dose of OARs compared to what planned.
Adaptive radiotherapy (ART) includes techniques that allow knowledge of patient-specific anatomical variations informed by Image-guided radiotherapies (IGRTs) to feedback into the plan and dose-delivery optimization during the treatment course. The persisting weakest link in the treatment chain for radiotherapy remains clinician-led target identification.
Compared to CT or CBCT, MRI offers superior soft-tissue definition with no associated radiation risk. MRI identifies targets larger than on CT because tumour that otherwise would have been missed is now seenah; however, most commonly, targets are reported to be smaller when delineated on MRI. The resulting smaller MRI-derived target improves the therapeutic ratio so enabling dose escalation. The availability of 'functional' MRI sequences holds promise that geometric adaptation maybe complemented by biological adaptation. Diffusion-weighted imaging (DWI) is a functional imaging technique dependent on the random motion of water molecules to generate image contrast. As tumours usually have greater cellularity than normal tissue, they demonstrate higher signal intensity, i.e., restricted diffusion on MRI. This is reflected in the low mean apparent diffusion coefficient (ADC) value. This has potential to provide both qualitative and quantitative information. Change in the ADC has been used to identify early treatment response, and to predict local recurrence. Therefore, on-board DWI could identify early non-responders who may benefit from change in treatment approach.
Radiomic is the extraction of quantitative features from medical images to characterize tumor pathology or heterogeneity. Radiomic features extracted from medical images can be used as in put features to create a machine learning model able to predict survival, and to guide treatment thanks to its predictive value in view of therapy personalization.
We previously evaluated in a retrospective study the qualitative analysis of the radiomic characteristics of head and neck tumor tissues, in order to identify a predictive signature of the biological characteristics of the tumor. The investigators stratified HNSCC patients according to the most significant radiomic features into high- and low-risk groups of relapse and survival after radio-chemotherapy.
The combination of both ART and radiomic analysis could potentially be considered a further advance in the personalization of oncological treatments, and in particular for radiation treatments. For this reason, the investigator designed the present research project with the aim to prospectively evaluate a machine learning-based radiomic approach to predict outcome and toxicity of HNSCC patients treated with ART by mean of CT, MRI and PET-scan.
- Conditions
- Head and Neck Cancer
- Being tested
- Adaptive Radiotherapy
- 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.
Adaptive RadiotherapyRadiation
All the patients will be treated with VMAT technique in its RapidArc form. A simultaneous integrated boost (SIB) technique will be used. The GTV will encompass the tumor delineated on CT scan, adjusted for MRI and PET scans. Patients will be treated with a total dose of 66 Gy, 60 Gy and 54 Gy on PTV1, PTV2 and PTV3, respectively, delivered in 30 fractions, 5 fractions per week.
| Study group | Role | What they receive |
|---|---|---|
| Adaptive Radiotherapy in Head and Neck cancer patients | Other | Patients will be treated with a total dose of 66 Gy, 60 Gy and 54 Gy on PTV1, PTV2 and PTV3, respectively, delivered in 30 fractions, 5 fractions per week.
At week 3 from RT start, patients will repeat contrast simulation CT with, and MRI and FDG-PET scan for treatment replanning. Patient will start with the new plan in week 4. Receives: Radiation: Adaptive Radiotherapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Locoregional recurrence free survival
Locoregional recurrence free survival in head and neck cancer patients treated with adaptive radiotherapy
Measured: 1 year
Secondary outcomes (2)
Progression Free Survival
Progression Free Survival in head and neck cancer patients treated with adaptive radiotherapy
Measured: 1 year
Overall Survival
Overall Survival in head and neck cancer patients treated with adaptive radiotherapy
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 posted18 Oct 2021
- Study start5 Oct 2021
- Primary completion31 May 2026 (estimated)
- Study completion31 May 2026 (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.
- More trials run by Istituto Clinico HumanitasThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 50 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Istituto Clinico Humanitas
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05081531
- Sponsor's protocol ID
- 2986
- Acronym
- RadiomicArt
- Status last verified
- Apr 2025
- First submitted
- 5 Oct 2021
- Last updated
- 30 Apr 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Apr 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Artificial Intelligence for Locally Advanced Head Neck Cancer Treated With Multi-modality Adaptive RadioTherapy: Machine Learning-based Radiomic Prediction of Outcome and Toxicity (RadiomicART)
- ClinicalTrials.gov ID
- NCT05081531
- Acronym / sponsor ID
- RadiomicArt / 2986
- Conditions
- Head and Neck Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 50 participants (estimated)
- Lead sponsor
- Istituto Clinico HumanitasUniversity, hospital or other
- Study start
- 5 Oct 2021 (actual)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 31 May 2026 (estimated)
- First posted
- 18 Oct 2021 (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.
Current clinical management algorithms for squamous cell carcinoma of head and neck (HNSCC) involve the use of surgery and / or radiotherapy (RT) depending on the stage of the disease at diagnosis. Radical RT, exclusive or in combination with systemic therapy, represents an effective therapeutic option according to the international guidelines. Despite the recent technological advancements in the field of RT, about 30-50% of patients will develop locoregional failure after primary treatment . Moreover, although the development of Intensity modulated radiation therapy (IMRT) and Volumetric modulated arc therapy (VMAT) techniques allowed a greater sparing of dose on healthy tissues, radiation-induced toxicity still represents a relevant concern, impacting on quality of life. The continuous effort of personalized medicine has the goal of improving patient's outcome, in terms of both disease's control and pattern of toxicity. Advanced imaging modalities appear to play an essential role in the customization of the radiation treatment as shown through the use of Adaptive Radiotherapy (ART) and radiomic. With ART we mean the adaptation of tumor volumes and surrounding organs at risk (OARs) to the shrinkage and patient emaciation during RT treatment. Adaptive radiotherapy (ART) includes techniques that allow knowledge of patient-specific anatomical variations informed by Image-guided radiotherapies (IGRTs) to feedback into the plan and dose-delivery optimization during the treatment course. Radiomic is the extraction of quantitative features from medical images to characterize tumor pathology or heterogeneity. Radiomic features extracted from medical images can be used as input features to create a machine learning model able to predict survival, and to guide treatment thanks to its predictive value in view of therapy personalization.
The combination of both ART and radiomic analysis could potentially be considered a further advance in the personalization of oncological treatments, and in particular for radiation treatments. For this reason, the investigators designed the present research project with the aim to prospectively evaluate a machine learning-based radiomic approach to predict outcome and toxicity of HNSCC patients treated with ART by mean of CT, MRI and PET-scan.
Detailed description
Squamous cell carcinoma of the head and neck (HNSCC) is characterized by an incidence in Europe of 140.000 new cases per year, with survival rates at 5 years ranging from 25 to 65%.
Current clinical management algorithms for HNSCC patients involve the use of surgery and / or radiotherapy depending on the stage of the disease at diagnosis. Radical radiotherapy (RT), exclusive or in combination with systemic therapy, represents an effective therapeutic option according to the international guidelines.
Despite the recent technological advancements in the field of radiation therapy, about 30-50% of patients will develop locoregional failure after primary treatment of head and neck cancer. Moreover, although the development of Intensity modulated radiation therapy (IMRT) and Volumetric modulated arc therapy (VMAT) techniques allowed a greater sparing of dose on healthy tissues, radiation-induced toxicity still represents a relevant concern, impacting on quality of life of cancer patients even for long time after treatment.
The continuous effort of personalized medicine has the goal of improving patient's outcome, in terms of both disease's control and pattern of toxicity. Advanced imaging modalities appear to play an essential role in the customization of the radiation treatment as shown through the use of Adaptive Radiotherapy (ART) and radiomic.
With ART the investigators mean the adaptation of tumor volumes and surrounding organs at risk (OARs) to the shrinkage and patient emaciation during RT treatment.
The recent literature showed that tumor shrinkage can reach 70% by the end of the RT treatment, and at the same time OARs, such as parotid glands, can reduce their size by 7 to 70%. These alterations, if not taken into account, can lead to an unexpected delivery of lower dose on the tumor and higher dose of OARs compared to what planned.
Adaptive radiotherapy (ART) includes techniques that allow knowledge of patient-specific anatomical variations informed by Image-guided radiotherapies (IGRTs) to feedback into the plan and dose-delivery optimization during the treatment course. The persisting weakest link in the treatment chain for radiotherapy remains clinician-led target identification.
Compared to CT or CBCT, MRI offers superior soft-tissue definition with no associated radiation risk. MRI identifies targets larger than on CT because tumour that otherwise would have been missed is now seenah; however, most commonly, targets are reported to be smaller when delineated on MRI. The resulting smaller MRI-derived target improves the therapeutic ratio so enabling dose escalation. The availability of 'functional' MRI sequences holds promise that geometric adaptation maybe complemented by biological adaptation. Diffusion-weighted imaging (DWI) is a functional imaging technique dependent on the random motion of water molecules to generate image contrast. As tumours usually have greater cellularity than normal tissue, they demonstrate higher signal intensity, i.e., restricted diffusion on MRI. This is reflected in the low mean apparent diffusion coefficient (ADC) value. This has potential to provide both qualitative and quantitative information. Change in the ADC has been used to identify early treatment response, and to predict local recurrence. Therefore, on-board DWI could identify early non-responders who may benefit from change in treatment approach.
Radiomic is the extraction of quantitative features from medical images to characterize tumor pathology or heterogeneity. Radiomic features extracted from medical images can be used as in put features to create a machine learning model able to predict survival, and to guide treatment thanks to its predictive value in view of therapy personalization.
We previously evaluated in a retrospective study the qualitative analysis of the radiomic characteristics of head and neck tumor tissues, in order to identify a predictive signature of the biological characteristics of the tumor. The investigators stratified HNSCC patients according to the most significant radiomic features into high- and low-risk groups of relapse and survival after radio-chemotherapy.
The combination of both ART and radiomic analysis could potentially be considered a further advance in the personalization of oncological treatments, and in particular for radiation treatments. For this reason, the investigator designed the present research project with the aim to prospectively evaluate a machine learning-based radiomic approach to predict outcome and toxicity of HNSCC patients treated with ART by mean of CT, MRI and PET-scan.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Adaptive Radiotherapy in Head and Neck cancer patients | Other | Radiation: Adaptive RadiotherapyPatients will be treated with a total dose of 66 Gy, 60 Gy and 54 Gy on PTV1, PTV2 and PTV3, respectively, delivered in 30 fractions, 5 fractions per week. At week 3 from RT start, patients will repeat contrast simulation CT with, and MRI and FDG-PET scan for treatment replanning. Patient will start with the new plan in week 4. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- ECOG Performance status 0 to 2
- Life expectancy > 12 months
- Histological proven squamous cell carcinoma of the pharynx, larynx or oral cavity
- Locally advanced stage disease classified as T3-T4 or N1-3
- Radical radiotherapy +/- chemotherapy indicated as the primary treatment modality
Key exclusion criteria (9 listed)
- Inability to provide informed consent
- Presence of distant metastases
- Previous radiation therapy on head and neck region
- Pregnant or breastfeeding patients
- Prior malignancy within the last five years (except adequately treated basal cell carcinoma of the skin or in situ carcinoma of the skin or in situ carcinoma of the cervix, surgically cured, or localized prostate cancer without evidence of biochemical progression)
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 |
|---|---|---|
| Adaptive RadiotherapyAll the patients will be treated with VMAT technique in its RapidArc form. A simultaneous integrated boost (SIB) technique will be used. The GTV will encompass the tumor delineated on CT scan, adjusted for MRI and PET scans. Patients will be treated with a total dose of 66 Gy, 60 Gy and 54 Gy on PTV1, PTV2 and PTV3, respectively, delivered in 30 fractions, 5 fractions per week. | Radiation | Adaptive Radiotherapy in Head and Neck cancer patients |
Primary outcome
Locoregional recurrence free survival
Time frame: 1 year
Locoregional recurrence free survival in head and neck cancer patients treated with adaptive radiotherapy
2 secondary outcomes
Progression Free Survival
Time frame: 1 year
Overall Survival
Time frame: 1 year
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 30 Apr 2026.
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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?
A study testing Adaptive Radiotherapy in people with Head and Neck Cancer, run by Istituto Clinico Humanitas at 1 site in Italy.
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 11 inclusion and 9 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 30 Apr 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 Italy. 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?
Locoregional recurrence free survival (time frame: 1 year). 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 30 Apr 2026.