Skull Base ChordomaNCT05888064
Multi-parametric Imaging in Personalized Radiotherapy
An observational study of Skull Base Chordoma, run by CNAO National Center of Oncological Hadrontherapy at 1 site in Italy.
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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Skull Base Chordoma
- What is being tested?
- diffusion MRI sequences
- How many people
- 35 participants
- Where
- 1 siteItaly
- Study dates
- 19 Apr 2022to 18 Aug 2025
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: skull-based chordoma patients treated with particle therapy at the National Center for Oncological Hadrontherapy (CNAO, Pavia, Italy).
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
Italy1 site, 1 recruiting
- Recruiting
CNAO
Pavia, Pv, 27100
Cristina Bono, MSc, 0382078613, cristina.bono@cnao.it
About this study
Official title: 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.
Read the 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).
- Conditions
- Skull Base Chordoma
- Being tested
- diffusion MRI sequences
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
diffusion MRI sequencesDiagnostic 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.
| Study group | Role | What they receive |
|---|---|---|
| Prospective non-invasive MRI acquisitions are planned to be performed | Prospective non-invasive MRI acquisitions are planned to be performed Receives: Diagnostic Test: diffusion MRI sequences | |
| retrospective group | patients treated for skull base chordoma with particle therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year from the treatment provided in routine clinical setting
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2023
- Study start19 Apr 2022
- Primary completion18 Aug 2025 (estimated)
- Study completion18 Aug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Skull Base ChordomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 35 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CNAO National Center of Oncological Hadrontherapy
- Sponsor type
- University, hospital or other
- Collaborators
- Dept. of Electronics, Informatics, Bioengineering, Politecnico di Milano, Italy
- Responsible party
- Sponsor
- Investigators
- Alberto Iannalfi, MD, Principal investigator, CNAO National Center of Oncological Hadrontherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05888064
- Sponsor's protocol ID
- CNAO 43 2021
- Status last verified
- Aug 2024
- First submitted
- 3 Mar 2023
- Last updated
- 21 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Technical Framework for Combining Multi-parametric Imaging With Advanced Modelling in Personalized Radiotherapy
- ClinicalTrials.gov ID
- NCT05888064
- Acronym / sponsor ID
- CNAO 43 2021
- Conditions
- Skull Base Chordoma
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 35 participants (estimated)
- Lead sponsor
- CNAO National Center of Oncological HadrontherapyUniversity, hospital or other
- Collaborators
- Dept. of Electronics, Informatics, Bioengineering, Politecnico di Milano, Italy
- Study start
- 19 Apr 2022 (actual)
- Primary completion
- 18 Aug 2025 (estimated)
- Study completion
- 18 Aug 2025 (estimated)
- First posted
- 5 Jun 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Prospective non-invasive MRI acquisitions are planned to be performed | – | Diagnostic Test: diffusion MRI sequencesProspective non-invasive MRI acquisitions are planned to be performed |
| retrospective group | – | –patients treated for skull base chordoma with particle therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- skull-based chordoma patients treated with particle therapy at the National Center for Oncological Hadrontherapy (CNAO, Pavia, Italy).
Key inclusion criteria (6 listed)
- 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
Key exclusion criteria (7 listed)
- Metastatic disease
- Palliative treatment
- Other malignancies with disease-free interval < 5 years (excepting pre- cancerous lesions)
- Pregnancy
- Simultaneous CHT or Immunotherapy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| diffusion MRI sequencesDiffusion 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. | Diagnostic test | Prospective non-invasive MRI acquisitions are planned to be performed |
Primary outcome
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.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Aug 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Alberto Iannalfi, MD principal investigator
CNAO National Center of Oncological Hadrontherapy
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Skull Base Chordoma, run by CNAO National Center of Oncological Hadrontherapy at 1 site in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 21 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Alberto Iannalfi, MD (0382078501, alberto.iannalfi@cnao.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
collect data from MRI acquisition (time frame: 1 year from the treatment provided in routine clinical setting). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Aug 2024.