Skull Base Chordoma
Conditions
Brief summary
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_TESTdiffusion 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.
Sponsors
Dept. of Electronics, Informatics, Bioengineering, Politecnico di Milano, Italy
CNAO National Center of Oncological Hadrontherapy
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| collect data from MRI acquisition | 1 year from the treatment provided in routine clinical setting | The prospective part of the study aims to collect data from MRI acquisition. It is not focused on patients treatment. |
Countries
Italy
Contacts
Primary ContactAlberto Iannalfi, MD
Backup ContactCristina Bono, MSc
Outcome results
None listed