Actively Recruiting

Age: 18Years +
All Genders
NCT03662373

Innovative SolutIons for DosimEtry in Hadrontherapy (INSIDE)

Led by CNAO National Center of Oncological Hadrontherapy · Updated on 2025-08-11

40

Participants Needed

1

Research Sites

337 weeks

Total Duration

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AI-Summary

What this Trial Is About

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

Official Title

Innovative SolutIons for DosimEtry in Hadrontherapy (INSIDE)

Who Can Participate

Age: 18Years +
All Genders

Eligibility Criteria

Eligible

You may qualify if you...

  • Patients treated at CNAO with protons or carbon ions using a horizontal beam line
  • Diagnosed with meningioma, adenoid cystic carcinoma, skull base (clivus) chordoma, or squamous cellular rhinopharynx carcinoma
  • Full compatibility of the INSIDE monitoring system with all beam delivery devices in the planned irradiation position
  • All emergency procedures remain possible with the INSIDE system positioned
  • Signed written informed consent from the patient
Not Eligible

You will not qualify if you...

  • Missing informed consent
  • Not diagnosed with one of the selected pathologies
  • Failure of pre-treatment compatibility technical assessment
  • Failure of pre-treatment emergency procedures check
  • Medical or individual reasons such as need for short time test

AI-Screening

AI-Powered Screening

Complete this quick 3-step screening to check your eligibility

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Trial Site Locations

Total: 1 location

1

CNAO

Pavia, Pavia, Italy, 27100

Actively Recruiting

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Research Team

V

Viviana Vitolo, MD

CONTACT

F

Francesca Valvo, MD

CONTACT

How is the study designed?

Study Type

OBSERVATIONAL

Masking

N/A

Allocation

N/A

Model

N/A

Primary Purpose

N/A

Number of Arms

2

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