Multi-parametric Imaging in Personalized Radiotherapy
ConditionSkull Base Chordoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCNAO National Center of Oncological Hadrontherapy
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
Metastatic disease
Palliative treatment
Other malignancies with disease-free interval < 5 years (excepting pre- cancerous lesions)
Pregnancy
Trial population
skull-based chordoma patients treated with particle therapy at the National Center for Oncological Hadrontherapy (CNAO, Pavia, Italy).
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
diffusion MRI sequences
Diagnostic testDiffusion 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.
Treatment groups
35 Participants
are divided into 2 treatment groupsGroup A: Prospective non-invasive MRI acquisitions are planned to be performed1 intervention
Group B: retrospective group0 interventions
Trial outcomes
Primary outcomes
1
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.
Time frame
1 year from the treatment provided in routine clinical settingSponsors and contacts
Click on the lead sponsor to view all of their trials.
CNAO National Center of Oncological Hadrontherapy
Lead sponsor
Dept. of Electronics, Informatics, Bioengineering, Politecnico di Milano, Italy
Collaborator
Source ClinicalTrials.gov