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Trial Title:
Multi-parametric Imaging in Personalized Radiotherapy
NCT ID:
NCT05888064
Condition:
Skull Base Chordoma
Conditions: Official terms:
Chordoma
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Diagnostic Test
Intervention name:
diffusion MRI sequences
Description:
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.
Arm group label:
Prospective non-invasive MRI acquisitions are planned to be performed
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).
Criteria for eligibility:
Study pop:
skull-based chordoma patients treated with particle therapy at the National Center for
Oncological Hadrontherapy (CNAO, Pavia, Italy).
Sampling method:
Probability Sample
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)
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
CNAO
Address:
City:
Pavia
Zip:
27100
Country:
Italy
Status:
Recruiting
Contact:
Last name:
Cristina Bono, MSc
Phone:
0382078613
Email:
cristina.bono@cnao.it
Start date:
April 19, 2022
Completion date:
August 18, 2025
Lead sponsor:
Agency:
CNAO National Center of Oncological Hadrontherapy
Agency class:
Other
Collaborator:
Agency:
Dept. of Electronics, Informatics, Bioengineering, Politecnico di Milano, Italy
Agency class:
Other
Source:
CNAO National Center of Oncological Hadrontherapy
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05888064
