Monitoring device for hadrontherapy treatments
Sperimentazione Clinica Del Sistema INSIDE - Innovative SolutIons for DosimEtry in Hadrontherapy - Per il Monitoraggio Del Trattamento in Adroterapia
This study is testing a new monitoring device to see if it can improve hadrontherapy treatments by providing real-time feedback on how the treatment is working for cancer patients.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 40 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | CNAO National Center of Oncological Hadrontherapy Academic / other |
| Locations | 1 site (Pavia, Pavia) |
| Trial ID | NCT03662373 on ClinicalTrials.gov |
What this trial studies
This study evaluates the clinical feasibility and effectiveness of the INSIDE system, an online monitoring device designed for hadrontherapy treatments. The system utilizes detectors to acquire secondary signals from the interaction of the particle beam with human tissues, allowing for real-time estimation of the particle beam range and compliance with treatment prescriptions. By longitudinally monitoring patients at the Italian National Centre of Oncological Hadrontherapy, the study aims to assess the stability of the INSIDE system's response and the clinical tolerances of treatment variations. This innovative approach seeks to enhance the effectiveness of hadrontherapy while minimizing damage to healthy tissues.
Who should consider this trial
Good fit: Ideal candidates include patients with meningioma, ACC, skull base chordoma, or squamous cellular rhinopharynx carcinoma receiving proton or carbon ion therapy at CNAO.
Not a fit: Patients who do not have one of the specified conditions or cannot provide informed consent will not benefit from this study.
Why it matters
Potential benefit: If successful, this monitoring system could significantly improve the precision and effectiveness of hadrontherapy treatments for cancer patients.
How similar studies have performed: While the approach of using in-beam monitoring systems is innovative, similar studies have shown promise in enhancing treatment accuracy in radiation therapy.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * 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. Exclusion Criteria * 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)
Where this trial is running
Pavia, Pavia
- Cnao — Pavia, Pavia, Italy (Recruiting)
Study contacts
- Principal investigator: Viviana Vitolo, MD — CNAO National Center of Oncological Hadrontherapy
- Study coordinator: Viviana Vitolo, MD
- Email: vitolo@cnao.it
- Phone: 00390382078501
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.