Multi-parametric Imaging in Personalized Radiotherapy

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

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.

Study Overview

• Status: Recruiting
• Conditions: Skull Base Chordoma
• Intervention / Treatment: Diagnostic test: diffusion MRI sequences

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).

• Study Type: Observational
• Enrollment (Estimated): 35

Contacts and Locations

• Study Contact: Name: Cristina Bono, MSc; Phone Number: 0382078613; Email: cristina.bono@cnao.it
• Study Contact Backup: Name: Alberto Iannalfi, MD; Phone Number: 0382078501; Email: alberto.iannalfi@cnao.it

Study Locations

• Italy
  • Pv
    • Pavia, Pv, Italy, 27100
      • Recruiting
      • CNAO
      • Contact: Cristina Bono, MSc; Phone Number: 0382078613; Email: cristina.bono@cnao.it

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Probability Sample

Study Population

skull-based chordoma patients treated with particle therapy at the National Center for Oncological Hadrontherapy (CNAO, Pavia, Italy).

Description

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)

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Prospective non-invasive MRI acquisitions are planned to be performed	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.
retrospective group; patients treated for skull base chordoma with particle therapy

What is the study measuring?

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

Collaborators and Investigators

• Sponsor: CNAO National Center of Oncological Hadrontherapy
• Collaborators: Dept. of Electronics, Informatics, Bioengineering, Politecnico di Milano, Italy
• Investigators: Principal Investigator: Alberto Iannalfi, MD, CNAO National Center of Oncological Hadrontherapy

Study record dates

Study Major Dates

• Study Start (Actual): April 19, 2022
• Primary Completion (Estimated): August 18, 2025
• Study Completion (Estimated): August 18, 2025

Study Registration Dates

• First Submitted: March 3, 2023
• First Submitted That Met QC Criteria: May 24, 2023
• First Posted (Actual): June 5, 2023

Study Record Updates

• Last Update Posted (Actual): August 21, 2024
• Last Update Submitted That Met QC Criteria: August 20, 2024
• Last Verified: August 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Germ Cell and Embryonal; Chordoma
• Other Study ID Numbers: CNAO 43 2021

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No