Multi-parametric Imaging in Personalized Radiotherapy

August 20, 2024 updated by: CNAO National Center of Oncological Hadrontherapy

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

Intervention / Treatment

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

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Italy
    • Pv
      • Pavia, Pv, Italy, 27100

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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
Time Frame: 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.
1 year from the treatment provided in routine clinical setting

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

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

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

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

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

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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