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Innovative SolutIons for DosimEtry in Hadrontherapy (INSIDE)

NCT03662373 · Status: RECRUITING · Type: OBSERVATIONAL · Enrollment: 40

Last updated 2025-08-11

No results posted yet for this 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.

Conditions

  • Particle Therapy

Interventions

RADIATION

carbon ions radiation therapy

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

RADIATION

protons radiation therapy

Proton radiation therapy used to treat meningioma and squamocellular rhinopharynx carcinoma

Sponsors & Collaborators

  • CNAO National Center of Oncological Hadrontherapy

    lead OTHER

Principal Investigators

  • Viviana Vitolo, MD · CNAO National Center of Oncological Hadrontherapy

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-07-16
Primary Completion
2025-12-31
Completion
2025-12-31

Countries

  • Italy

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03662373 on ClinicalTrials.gov