Multi-parametric Imaging in Personalized Radiotherapy

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

35 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-04-19

Study Completion Date

2025-08-18

Brief Summary

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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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Detailed Description

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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).

Conditions

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Skull Base Chordoma

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Prospective non-invasive MRI acquisitions are planned to be performed

diffusion MRI sequences

Intervention Type 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.

retrospective group

patients treated for skull base chordoma with particle therapy

No interventions assigned to this group

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No