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

Study acronym: RadiomicArt
StatusActive, Not Recruiting
PhaseNot applicable
Started
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Record status
This record was last updated April 30, 2026 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

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  1. Notable Primary and study completion dates: Oct 1, 2025 to May 31, 2026v5
  2. Notable Primary and study completion dates: Oct 1, 2024 to Oct 1, 2025
    • Trial status: Recruiting to Active, Not Recruiting
    • Site details revised
    v4
  3. Minor Re-verified, no change to tracked fieldsv3
  4. Minor Study description expanded, about 3 words
    • Study title shortened, about 4 words
    v2
  5. Minor Study First Submitted
  • Stopped: an ongoing trial was terminated, suspended or withdrawn.
  • Notable: the trial’s plan changed such as a big move in its timeline or size, a new primary endpoint, sponsor or phase, or recruiting opened or resumed.
  • Minor: routine progress and housekeeping, such as sites added or enrollment closed.
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.
Trial Details
NCT Number NCT05081531
Lead Sponsor Istituto Clinico Humanitas
Conditions
(from sponsor)
Head and Neck Cancer
Related terms Head and Neck Neoplasms
Enrollment 50 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov