Multi-parametric Imaging in Personalized Radiotherapy
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: diffusion MRI sequences.
- Who it may be relevant to
- Registry conditions: Skull Base Chordoma. Basic parameters: from 18 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Italy
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
A Technical Framework for Combining Multi-parametric Imaging With Advanced Modelling in Personalized Radiotherapy
Overview
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
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).
Interventions
- Diagnostic test diffusion MRI sequences
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.
Primary outcome measures
- collect data from MRI acquisition [Time frame: 1 year from the treatment provided in routine clinical setting]
Eligibility criteria
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)
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
Italy · 1 center
- CNAO — Pavia
Identifiers
NCT: NCT05888064 · CNAO 43 2021