Innovative SolutIons for DosimEtry in Hadrontherapy (INSIDE)

NCT03662373 | Recruiting

• 1 other identifier: CNAO-OSSINSIDE-02-18
• Study Type: observational
• Target: 40
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

on line monitoring; PET in beam; Hadrontherapy

Outcome Measures

Primary Outcomes (2)

• particles ranges

  evaluate the quality of treatments in term of data collection and of particles range evaluated with PET scanner and Monte Carlo simulations

  average of 5 weeks (as a treatment duration)

• particles ranges for each pathology considered

  statistical analysis to assess the evaluations of treatment

  4 months

Study Arms (2)

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

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

Radiation: protons radiation therapy

Interventions

carbon ions radiation therapy RADIATION

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

Also known as: particle therapy

carbon ions radiation therapy

protons radiation therapy RADIATION

Proton radiation therapy used to treat meningioma and squamocellular rhinopharynx carcinoma

Also known as: particle therapy

protons radiation therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

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.

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• CNAO National Center of Oncological Hadrontherapy: lead

Study Sites (1)

CNAO

Pavia, Pavia, 27100, Italy

RECRUITING

Study Officials

• Viviana Vitolo, MD

  CNAO National Center of Oncological Hadrontherapy

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Viviana Vitolo, MD

CONTACT

00390382078501; vitolo@cnao.it

Francesca Valvo, MD

CONTACT

00390382078501; direzionemedica@cnao.it

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 3, 2018
• First Posted: September 7, 2018
• Study Start: July 16, 2019
• Primary Completion: December 31, 2025
• Study Completion: December 31, 2025
• Last Updated: August 11, 2025

Record last verified: 2025-02

Locations

IT (1)