Multi-parametric Imaging in Personalized Radiotherapy

Study Overview
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Brief Summary
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The study consists in the retrospective and prospective collection of imaging data (along with clinical information related to treatment) of skull-base chordoma patients treated with particle therapy, to derive imaging biomarkers which, integrated with advanced mathematical models, will allow predicting treatment outcome on a multi-scale basis.

Detailed Description
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The study design consists of the retrospective collection of routinely-acquired data (CT, MRI and dose maps, along with relevant clinical information) and the prospective acquisition of optimized non-invasive MR imaging data, of skull-based chordoma patients treated with particle therapy (PT) at the National Center for Oncological Hadrontherapy (CNAO, Pavia, Italy). This data will be stored in a proper repository under CNAO's control, shared with Politecnico di Milano through encrypted channels, and it will be used to implement mathematical models able to predict treatment outcome at different scales (macroscopic, microscopic and radiobiological).

Official Title
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A Technical Framework for Combining Multi-parametric Imaging With Advanced Modelling in Personalized Radiotherapy

Conditions
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Skull Base Chordoma

Intervention / Treatment
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* Diagnostic Test: diffusion MRI sequences


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Patients with histologically confirmed diagnosis of chordoma of the skull base Particle therapy with curative intent Karnofsky Performance status greater than or equal to 60 Patients with macroscopic disease detectable at pre-radiotherapy imaging Patients undergoing PT with standardized treatment procedures Patients who have signed the written informed consent for research Exclusion Criteria: Metastatic disease Palliative treatment Other malignancies with disease-free interval < 5 years (excepting pre- cancerous lesions) Pregnancy Simultaneous CHT or Immunotherapy Extensive metal instrumentation/implants Patients with autoimmune diseases (ADs) -including collagen-vascular (CVD) and inflammatory bowel (IBD)

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Prospective non-invasive MRI acquisitions are planned to be performed<br>Prospective non-invasive MRI acquisitions are planned to be performed | Diagnostic Test: diffusion MRI sequences<br>* Diffusion MRI sequences will be optimized to derive more accurate estimates of microstructure and microvasculature of tumour and healthy organs: multiple b-values will be acquired and advanced diffusivity models considered. MRI sequences to derive tumour hypoxia (i.e. indicative of radioresistance) will be also considered along with MR spectroscopy to evaluate tumour microenvironment.<br>|
| retrospective group<br>patients treated for skull base chordoma with particle therapy | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| collect data from MRI acquisition | The prospective part of the study aims to collect data from MRI acquisition. It is not focused on patients treatment. | 1 year from the treatment provided in routine clinical setting |