Multi-parametric Imaging in Personalized Radiotherapy

Skull Base Chordoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05888064
• Other study ID #: CNAO 43 2021
• Status: Recruiting
• Start date: April 19, 2022
• Est. completion date: April 18, 2025

Study information

• Verified date: June 2023
• Source: CNAO National Center of Oncological Hadrontherapy
• Contact: Alberto Iannalfi, MD
• Phone: 0382078501
• Email: alberto.iannalfi[@]cnao.it
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 35
• Est. completion date: April 18, 2025
• Est. primary completion date: February 18, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Chordoma
• Skull Base Chordoma

Intervention

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.

Locations

Country	Name	City	State
Italy	CNAO	Pavia	Pv

Sponsors (2)

Lead Sponsor	Collaborator
CNAO National Center of Oncological Hadrontherapy	Dept. of Electronics, Informatics, Bioengineering, Politecnico di Milano, Italy

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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