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NCT Number: NCT05888064

Multi-parametric Imaging 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.

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Key information

Conditions

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

Primary outcomes

  1. 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.

Study contacts

Contact information is provided by the study sponsor or research team.

Alberto Iannalfi, MD

CONTACT

[email protected]

0382078501

Cristina Bono, MSc

CONTACT

[email protected]

0382078613

Sponsors and collaborators

Lead sponsor

CNAO National Center of Oncological Hadrontherapy

Other

Collaborators

  • Dept. of Electronics, Informatics, Bioengineering, Politecnico di Milano, Italy

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2025
Study completion
2025
First posted
Jun 5, 2023
Registry last updated
Aug 21, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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