Particle TherapyINSIDENCT03662373
Innovative SolutIons for DosimEtry in Hadrontherapy (INSIDE)
An observational study of Particle Therapy, run by CNAO National Center of Oncological Hadrontherapy at 1 site in Italy.
Trial summary
The study aim is to test the clinical feasibility and effectiveness of an online qualitative monitoring device named INSIDE system during hadrontherapy treatments. This instrumentation is composed by detectors able to acquire secondary signals generated by the interaction of the primary beam with human tissues. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Particle Therapy
- What is being tested?
- carbon ions radiation therapy and protons radiation therapy
- Type of treatment
- Surgery or procedure
- How many people
- 40 participants
- Where
- 1 siteItaly
- Study dates
- 16 Jul 2019to 31 Dec 2025
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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: Study population is represented by all patients undergoing to treatment at CNAO, selected on the pathology and on the particle used for their radiation therapy. 40 patients affected by one of the four pathologies foreseen and which can offer morphological variations during treatment cycle.
Who may be able to join
- patients treated at CNAO with protons or carbon ions with horizontal beam line.
- meningioma, ACC, skull base (clivus) chordoma, squamous cellular rhinopharynx carcinoma
- full compatibility of the INSIDE monitoring system with all beam delivery devices in the established irradiating position
- all emergency procedures are possible notwithstanding INSIDE system positioned.
- signed written informed consent by patient.
Who cannot join
- missing informed consent
- not affected by one of the selected pathologies
- failure of pre-treatment compatibility technical assessment
- failure of pre-treatment emergency procedures check
- medical or individual reasons (i.e. short time test needed)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Italy1 site, 1 recruiting
- Recruiting
CNAO
Pavia, Pavia, 27100
Cristina Bono, MSc, +39(0)382078613, cristina.bono@cnao.it
About this study
Official title: Sperimentazione Clinica Del Sistema INSIDE - Innovative SolutIons for DosimEtry in Hadrontherapy - Per il Monitoraggio Del Trattamento in Adroterapia
The study aim is to test the clinical feasibility and effectiveness of an online qualitative monitoring device named INSIDE system during hadrontherapy treatments.
This instrumentation is composed by detectors able to acquire secondary signals generated by the interaction of the primary beam with human tissues. From these measurements performed during irradiation, the INSIDE system estimates the particle beam range inside the patient's body and check the compliance of the ongoing treatment with the clinical prescription, with the aim to optimize the delivered dose.
Read more
The study aims to longitudinally monitor patients treated with hadrontherapy at the Italian National Centre of Oncological Hadrontherapy (CNAO) in Pavia in order to:
- evaluate the stability of the INSIDE system response and the significance of the monitoring measurement;
- study the clinical tolerances between ongoing and prescribed treatments within which the differences in particle range are not clinically relevant;
- assess what impact an instrument such as the INSIDE system can have on the clinical routine;
- evaluate the benefits of such a monitoring system with respect to treatment planning constraints.
Read the detailed description
A treatment monitoring instrumentation is highly demanded to maximize the benefits of hadrontherapy from the increased conformation of the released dose to the tumor volume with respect to the conventional radiotherapy.
Since almost all the energy of the charged particles is deposited in the end of their track (Bragg Peak region), the verification of the particle range by experimental measurements, performed during treatment delivery, can help to increase the therapy effectiveness while better sparing healthy tissues.
The INSIDE system is an innovative bi-modal instrumentation consisting of an in-beam Positron Emission Tomography (PET) scanner, to detect annihilation photons coming from positron isotope emitters, and a Dose Profiler to collect signals from charged particles emitted during treatment (e.g. protons in the case of carbon ion treatments).
The in-beam PET scanner is composed by two opposite panels of detectors placed above and below the patient bed, respectively. The Dose Profiler is positioned above the patient with an angle of 60°, forwardly with respect to the beam direction.
The INSIDE system is a passive instrumentation, i.e. no additional dose has to be released to the patient for particle range verification.
The INSIDE detectors are mounted on a mobile support and, immediately before the treatment delivery, they will be placed around the patient in the acquisition position, thanks to a dedicated hooking system designed to guarantee the maximum precision and accuracy in the particle range verification.
The INSIDE system mechanics is compatible with multi fields irradiation of patients affected by pathologies of Head-and-Neck and Brain districts.
In the clinical trial, patients affected by four selected pathologies will be included: meningioma and nasopharynx cancers treated with proton beams, Adenoid Cystic Carcinoma (ACC) and clival chordoma treated with carbon ion beams. These were chosen in order to study both projectile particles available at the CNAO centre (i.e., protons and carbon ions), and target specific pathologies which should most benefit from the range monitoring provided by the INSIDE system. Among them are cancers for which an early response is commonly observed and tumors which are located near cavities that can be filled with either water-like material (such as cancerous mass and inflamed tissues) or air.
The patients will undergo a longitudinal protocol of measurements in order to verify the agreement between the ongoing treatment and the prescription throughout the complete treatment period (lasting in average about 4-6 weeks for the selected pathologies).
- Conditions
- Particle Therapy
- Being tested
- carbon ions radiation therapy, protons radiation therapy
- Keywords
- on line monitoring, PET in beam, Hadrontherapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
carbon ions radiation therapyRadiation
Also called particle therapy
Carbon ion radiation therapy to treat adenoid cystic carcinoma, skull base (clivus) chordoma.
protons radiation therapyRadiation
Also called particle therapy
Proton radiation therapy used to treat meningioma and squamocellular rhinopharynx carcinoma
| Study group | Role | What they receive |
|---|---|---|
| carbon ions radiation therapy | the group of patients treated with carbon ion radiation therapy, affected by one of the four pathologies foreseen in inclusion criteria Receives: Radiation: carbon ions radiation therapy | |
| protons radiation therapy | the group of patients treated with proton radiation therapy, affected by one of the four pathologies foreseen in inclusion criteria Receives: Radiation: protons radiation therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
particles ranges
evaluate the quality of treatments in term of data collection and of particles range evaluated with PET scanner and Monte Carlo simulations
Measured: average of 5 weeks (as a treatment duration)
particles ranges for each pathology considered
statistical analysis to assess the evaluations of treatment
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Sep 2018
- Study start16 Jul 2019
- Primary completion31 Dec 2025 (estimated)
- Study completion31 Dec 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Particle TherapyStudies 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
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CNAO National Center of Oncological Hadrontherapy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Viviana Vitolo, MD, Principal investigator, CNAO National Center of Oncological Hadrontherapy
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03662373
- Sponsor's protocol ID
- CNAO-OSSINSIDE-02-18
- Acronym
- INSIDE
- Status last verified
- Feb 2025
- First submitted
- 3 Jul 2018
- Last updated
- 11 Aug 2025
- 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 11 Aug 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Sperimentazione Clinica Del Sistema INSIDE - Innovative SolutIons for DosimEtry in Hadrontherapy - Per il Monitoraggio Del Trattamento in Adroterapia
- ClinicalTrials.gov ID
- NCT03662373
- Acronym / sponsor ID
- INSIDE / CNAO-OSSINSIDE-02-18
- Conditions
- Particle Therapy
- Keywords
- on line monitoring, PET in beam, Hadrontherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- CNAO National Center of Oncological HadrontherapyUniversity, hospital or other
- Study start
- 16 Jul 2019 (actual)
- Primary completion
- 31 Dec 2025 (estimated)
- Study completion
- 31 Dec 2025 (estimated)
- First posted
- 7 Sep 2018 (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 aim is to test the clinical feasibility and effectiveness of an online qualitative monitoring device named INSIDE system during hadrontherapy treatments.
This instrumentation is composed by detectors able to acquire secondary signals generated by the interaction of the primary beam with human tissues. From these measurements performed during irradiation, the INSIDE system estimates the particle beam range inside the patient's body and check the compliance of the ongoing treatment with the clinical prescription, with the aim to optimize the delivered dose.
The study aims to longitudinally monitor patients treated with hadrontherapy at the Italian National Centre of Oncological Hadrontherapy (CNAO) in Pavia in order to:
- evaluate the stability of the INSIDE system response and the significance of the monitoring measurement;
- study the clinical tolerances between ongoing and prescribed treatments within which the differences in particle range are not clinically relevant;
- assess what impact an instrument such as the INSIDE system can have on the clinical routine;
- evaluate the benefits of such a monitoring system with respect to treatment planning constraints.
Detailed description
A treatment monitoring instrumentation is highly demanded to maximize the benefits of hadrontherapy from the increased conformation of the released dose to the tumor volume with respect to the conventional radiotherapy.
Since almost all the energy of the charged particles is deposited in the end of their track (Bragg Peak region), the verification of the particle range by experimental measurements, performed during treatment delivery, can help to increase the therapy effectiveness while better sparing healthy tissues.
The INSIDE system is an innovative bi-modal instrumentation consisting of an in-beam Positron Emission Tomography (PET) scanner, to detect annihilation photons coming from positron isotope emitters, and a Dose Profiler to collect signals from charged particles emitted during treatment (e.g. protons in the case of carbon ion treatments).
The in-beam PET scanner is composed by two opposite panels of detectors placed above and below the patient bed, respectively. The Dose Profiler is positioned above the patient with an angle of 60°, forwardly with respect to the beam direction.
The INSIDE system is a passive instrumentation, i.e. no additional dose has to be released to the patient for particle range verification.
The INSIDE detectors are mounted on a mobile support and, immediately before the treatment delivery, they will be placed around the patient in the acquisition position, thanks to a dedicated hooking system designed to guarantee the maximum precision and accuracy in the particle range verification.
The INSIDE system mechanics is compatible with multi fields irradiation of patients affected by pathologies of Head-and-Neck and Brain districts.
In the clinical trial, patients affected by four selected pathologies will be included: meningioma and nasopharynx cancers treated with proton beams, Adenoid Cystic Carcinoma (ACC) and clival chordoma treated with carbon ion beams. These were chosen in order to study both projectile particles available at the CNAO centre (i.e., protons and carbon ions), and target specific pathologies which should most benefit from the range monitoring provided by the INSIDE system. Among them are cancers for which an early response is commonly observed and tumors which are located near cavities that can be filled with either water-like material (such as cancerous mass and inflamed tissues) or air.
The patients will undergo a longitudinal protocol of measurements in order to verify the agreement between the ongoing treatment and the prescription throughout the complete treatment period (lasting in average about 4-6 weeks for the selected pathologies).
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| carbon ions radiation therapy | – | Radiation: carbon ions radiation therapythe group of patients treated with carbon ion radiation therapy, affected by one of the four pathologies foreseen in inclusion criteria |
| protons radiation therapy | – | Radiation: protons radiation therapythe group of patients treated with proton radiation therapy, affected by one of the four pathologies foreseen in inclusion criteria |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Study population is represented by all patients undergoing to treatment at CNAO, selected on the pathology and on the particle used for their radiation therapy. 40 patients affected by one of the four pathologies foreseen and which can offer morphological variations during treatment cycle.
Key inclusion criteria (5 listed)
- patients treated at CNAO with protons or carbon ions with horizontal beam line.
- meningioma, ACC, skull base (clivus) chordoma, squamous cellular rhinopharynx carcinoma
- full compatibility of the INSIDE monitoring system with all beam delivery devices in the established irradiating position
- all emergency procedures are possible notwithstanding INSIDE system positioned.
- signed written informed consent by patient.
Key exclusion criteria (5 listed)
- missing informed consent
- not affected by one of the selected pathologies
- failure of pre-treatment compatibility technical assessment
- failure of pre-treatment emergency procedures check
- medical or individual reasons (i.e. short time test needed)
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 |
|---|---|---|
| carbon ions radiation therapyAlso: particle therapyCarbon ion radiation therapy to treat adenoid cystic carcinoma, skull base (clivus) chordoma. | Radiation | carbon ions radiation therapy |
| protons radiation therapyAlso: particle therapyProton radiation therapy used to treat meningioma and squamocellular rhinopharynx carcinoma | Radiation | protons radiation therapy |
Primary outcome
particles ranges
Time frame: average of 5 weeks (as a treatment duration)
evaluate the quality of treatments in term of data collection and of particles range evaluated with PET scanner and Monte Carlo simulations
particles ranges for each pathology considered
Time frame: 4 months
statistical analysis to assess the evaluations of treatment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Aug 2025.
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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.
Viviana Vitolo, 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 Particle Therapy, 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 5 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 11 Aug 2025. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Viviana Vitolo, MD (00390382078501, vitolo@cnao.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
particles ranges (time frame: average of 5 weeks (as a treatment duration)). The study lists 2 primary outcomes in all. 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 11 Aug 2025.