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NCT05081531Active, not recruiting

AI for Head Neck Cancer Treated With Adaptive RadioTherapy (RadiomicART)

Artificial Intelligence for Locally Advanced Head Neck Cancer Treated With Multi-modality Adaptive RadioTherapy: Machine Learning-based Radiomic Prediction of Outcome and Toxicity (RadiomicART)

Source: ClinicalTrials.gov · Last updated 30 Apr 2026

Brief summary (registry, in English)

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.

Status (registry)
Active, not recruiting
Study type
Interventional
Enrollment
50 (estimated)
First submitted
5 Oct 2021
Start date
5 Oct 2021
Primary completion date
31 May 2026
Lead sponsor
Istituto Clinico Humanitas
NCT number
NCT05081531

What you commit to

  • Study type: Interventional
  • Planned participants: 50
  • From 5 Oct 2021 to the primary completion date, 31 May 2026
  • 1 site in 1 country
  • Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

  • Previous radiation therapy on head and neck region

Other illness

  • 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
  • Allergy or contraindication to contrast agents

Other

  • Inability to provide informed consent
  • Presence of distant metastases
  • Pregnant or breastfeeding patients
  • General contraindications to MRI
  • ECOG PS \>=3

Who the study is looking for

  • 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
  • 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

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Save your city in your profile to sort them by distance.

SiteCityCountrySite status
Humanitas Clinical institute
Coordinator of this site? Confirm its status
RozzanoItalyUnknown status

This page is information, not medical advice. Discuss any trial with your doctor.