Innovative SolutIons for DosimEtry in Hadrontherapy (INSIDE)

NCT03662373 · tracked via the Priya Life Science Italy tracker

Sponsor

CNAO National Center of Oncological Hadrontherapy

Phase

Observational

Started

2019-07-16

Last updated

2025-08-11

Condition(s) studied

Particle Therapy

Investigational drug(s) / intervention(s)

carbon ions radiation therapyprotons radiation therapy

carbon ions radiation therapy: Carbon ion radiation therapy to treat adenoid cystic carcinoma, skull base (clivus) chordoma.

protons radiation therapy: Proton radiation therapy used to treat meningioma and squamocellular rhinopharynx carcinoma

Study 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. 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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

—

Healthy volunteers

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)

Primary outcome measure(s)

particles ranges — 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 — 4 months
statistical analysis to assess the evaluations of treatment

Trial sites (1)

Facility	City	Region	Status
CNAO	Pavia	Pavia	Recruiting

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT03662373 on ClinicalTrials.gov ↗ ← All trials in Italy