Actively Recruiting
Innovative Solutions for Dosimetry in Hadrontherapy (INSIDE) Monitoring System for Treatment Verification in Particle Therapy
Led by CNAO National Center of Oncological Hadrontherapy · Updated on 2025-08-11
40
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the clinical feasibility and effectiveness of an innovative online monitoring device called the INSIDE system during hadrontherapy treatments for certain cancers. The study focuses on patients treated at the Italian National Centre of Oncological Hadrontherapy with proton or carbon ion radiation for specific tumors such as meningioma, nasopharynx cancer, adenoid cystic carcinoma, and clival chordoma. The goal is to measure how well the INSIDE system can track the particle beam range inside the patient's body and ensure treatment matches the clinical plan, aiming to optimize the dose delivered while protecting healthy tissues. The INSIDE system combines two types of detectors: an in-beam Positron Emission Tomography (PET) scanner and a Dose Profiler, which collect signals generated during treatment without adding extra radiation to the patient. These detectors are placed around the patient immediately before treatment and remain in position during the irradiation. The system is compatible with multi-field irradiation and is used during the entire treatment period, which typically lasts about 4 to 6 weeks for the selected conditions. The study groups include patients receiving either carbon ion radiation therapy or proton radiation therapy. Participants undergo a longitudinal monitoring protocol where measurements are taken throughout the treatment to compare the ongoing therapy with the prescribed plan. Researchers will evaluate the stability of the INSIDE system's response, the clinical tolerances for particle range differences, and the potential benefits of integrating the system into routine clinical practice. The primary outcomes focus on particle range measurements averaged over five weeks and separately analyzed for each pathology over four months. The study's total duration and assessments support optimizing hadrontherapy treatment delivery and safety.
CONDITIONS
Brief Title
Innovative SolutIons for DosimEtry in Hadrontherapy (INSIDE)
Who Can Participate
Eligibility Criteria
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 established irradiating position
- All emergency procedures possible while INSIDE system is positioned
- Signed written informed consent by the patient
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 preventing participation (e.g., short time test needed)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - Approximately 4 to 6 weeks
Participants undergoing proton or carbon ion radiation therapy are monitored using the INSIDE system to verify particle range during treatment delivery without additional radiation exposure.
Visits occur during each treatment session over the treatment period
Duration - Up to 4 months
Participants are observed to verify the agreement between ongoing treatment and the prescription throughout the complete treatment period and up to 4 months for assessing particle ranges by pathology.
Follow-up visits as scheduled for long-term assessment
Trial Site Locations
Total: 1 location
1
CNAO
Pavia, Pavia, Italy, 27100
Actively Recruiting
Research Team
V
Viviana Vitolo, MD
F
Francesca Valvo, MD
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
Frequently Asked Questions
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