Innovative SolutIons for DosimEtry in Hadrontherapy (INSIDE)
ConditionParticle Therapy
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorCNAO National Center of Oncological Hadrontherapy
About this trial
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 criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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
Trial 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.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
carbon ions radiation therapy
RadiationCarbon ion radiation therapy to treat adenoid cystic carcinoma, skull base (clivus) chordoma.
protons radiation therapy
RadiationProton radiation therapy used to treat meningioma and squamocellular rhinopharynx carcinoma
Treatment groups
40 Participants
are divided into 2 treatment groupsGroup A: carbon ions radiation therapy1 intervention
Group B: protons radiation therapy1 intervention
Trial outcomes
Primary outcomes
1
particles ranges
evaluate the quality of treatments in term of data collection and of particles range evaluated with PET scanner and Monte Carlo simulations
Time frame
average of 5 weeks (as a treatment duration)2
particles ranges for each pathology considered
statistical analysis to assess the evaluations of treatment
Time frame
4 monthsSponsors and contacts
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Source ClinicalTrials.gov