Multi-parametric Imaging in Personalized Radiotherapy

NCT05888064 | Recruiting

• 1 other identifier: CNAO 43 2021
• Study Type: observational
• Target: 35
• Locations: 1 country
• Sites: 1

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.

Conditions

Skull Base Chordoma

Outcome Measures

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.

  1 year from the treatment provided in routine clinical setting

Study Arms (2)

Prospective non-invasive MRI acquisitions are planned to be performed

Prospective non-invasive MRI acquisitions are planned to be performed

Diagnostic Test: diffusion MRI sequences

retrospective group

patients treated for skull base chordoma with particle therapy

Interventions

diffusion MRI sequences DIAGNOSTIC_TEST

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.

Prospective non-invasive MRI acquisitions are planned to be performed

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• CNAO National Center of Oncological Hadrontherapy: lead
• Dept. of Electronics, Informatics, Bioengineering, Politecnico di Milano, Italy: collaborator

Study Sites (1)

CNAO

Pavia, Pv, 27100, Italy

RECRUITING

Study Officials

• Alberto Iannalfi, MD

  CNAO National Center of Oncological Hadrontherapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Alberto Iannalfi, MD

CONTACT

0382078501; alberto.iannalfi@cnao.it

Cristina Bono, MSc

CONTACT

0382078613; cristina.bono@cnao.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 3, 2023
• First Posted: June 5, 2023
• Study Start: April 19, 2022
• Primary Completion: August 18, 2025
• Study Completion: August 18, 2025
• Last Updated: August 21, 2024

Record last verified: 2024-08

Locations

IT (1)