Sperimentazione Clinica Del Sistema INSIDE - Innovative SolutIons for DosimEtry in Hadrontherapy - Per il Monitoraggio Del Trattamento in Adroterapia

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Observational
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Italy
CNAO
RECRUITING
Pavia
Contact Information
Primary
Viviana Vitolo, MD
vitolo@cnao.it
00390382078501
Backup
Francesca Valvo, MD
direzionemedica@cnao.it
00390382078501
Time Frame
Start Date: 2019-07-16
Estimated Completion Date: 2025-12-31
Participants
Target number of participants: 40
Treatments
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
protons radiation therapy
the group of patients treated with proton radiation therapy, affected by one of the four pathologies foreseen in inclusion criteria
Sponsors
Leads: CNAO National Center of Oncological Hadrontherapy

This content was sourced from clinicaltrials.gov