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Innovative SolutIons for DosimEtry in Hadrontherapy (INSIDE) (INSIDE)

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ClinicalTrials.gov Identifier: NCT03662373
Recruitment Status : Recruiting
First Posted : September 7, 2018
Last Update Posted : July 21, 2020
Sponsor:
Information provided by (Responsible Party):
CNAO National Center of Oncological Hadrontherapy

Tracking Information
First Submitted Date July 3, 2018
First Posted Date September 7, 2018
Last Update Posted Date July 21, 2020
Actual Study Start Date July 16, 2019
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: September 6, 2018)
  • particles ranges [ Time Frame: average of 5 weeks (as a treatment duration) ]
    evaluate the quality of treatments in term of data collection and of particles range evaluated with PET scanner and Monte Carlo simulations
  • particles ranges for each pathology considered [ Time Frame: 4 months ]
    statistical analysis to assess the evaluations of treatment
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures Not Provided
Original Secondary Outcome Measures Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Innovative SolutIons for DosimEtry in Hadrontherapy (INSIDE)
Official Title Sperimentazione Clinica Del Sistema INSIDE - Innovative SolutIons for DosimEtry in Hadrontherapy - Per il Monitoraggio Del Trattamento in Adroterapia
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.
Detailed Description

A treatment monitoring instrumentation is highly demanded to maximize the benefits of hadrontherapy from the increased conformation of the released dose to the tumor volume with respect to the conventional radiotherapy.

Since almost all the energy of the charged particles is deposited in the end of their track (Bragg Peak region), the verification of the particle range by experimental measurements, performed during treatment delivery, can help to increase the therapy effectiveness while better sparing healthy tissues.

The INSIDE system is an innovative bi-modal instrumentation consisting of an in-beam Positron Emission Tomography (PET) scanner, to detect annihilation photons coming from positron isotope emitters, and a Dose Profiler to collect signals from charged particles emitted during treatment (e.g. protons in the case of carbon ion treatments).

The in-beam PET scanner is composed by two opposite panels of detectors placed above and below the patient bed, respectively. The Dose Profiler is positioned above the patient with an angle of 60°, forwardly with respect to the beam direction.

The INSIDE system is a passive instrumentation, i.e. no additional dose has to be released to the patient for particle range verification.

The INSIDE detectors are mounted on a mobile support and, immediately before the treatment delivery, they will be placed around the patient in the acquisition position, thanks to a dedicated hooking system designed to guarantee the maximum precision and accuracy in the particle range verification.

The INSIDE system mechanics is compatible with multi fields irradiation of patients affected by pathologies of Head-and-Neck and Brain districts.

In the clinical trial, patients affected by four selected pathologies will be included: meningioma and nasopharynx cancers treated with proton beams, Adenoid Cystic Carcinoma (ACC) and clival chordoma treated with carbon ion beams. These were chosen in order to study both projectile particles available at the CNAO centre (i.e., protons and carbon ions), and target specific pathologies which should most benefit from the range monitoring provided by the INSIDE system. Among them are cancers for which an early response is commonly observed and tumors which are located near cavities that can be filled with either water-like material (such as cancerous mass and inflamed tissues) or air.

The patients will undergo a longitudinal protocol of measurements in order to verify the agreement between the ongoing treatment and the prescription throughout the complete treatment period (lasting in average about 4-6 weeks for the selected pathologies).

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
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.
Condition Particle Therapy
Intervention
  • Radiation: carbon ions radiation therapy
    Carbon ion radiation therapy to treat adenoid cystic carcinoma, skull base (clivus) chordoma.
    Other Name: particle therapy
  • Radiation: protons radiation therapy
    Proton radiation therapy used to treat meningioma and squamocellular rhinopharynx carcinoma
    Other Name: particle therapy
Study Groups/Cohorts
  • 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
    Intervention: 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
    Intervention: Radiation: protons radiation therapy
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: September 6, 2018)
40
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2020
Estimated Primary Completion Date December 31, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • 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.

Exclusion Criteria

  • 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)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Viviana Vitolo, MD 00390382078501 vitolo@cnao.it
Contact: Francesca Valvo, MD 00390382078501 direzionemedica@cnao.it
Listed Location Countries Italy
Removed Location Countries  
 
Administrative Information
NCT Number NCT03662373
Other Study ID Numbers CNAO-OSSINSIDE-02-18
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party CNAO National Center of Oncological Hadrontherapy
Study Sponsor CNAO National Center of Oncological Hadrontherapy
Collaborators Not Provided
Investigators
Principal Investigator: Viviana Vitolo, MD CNAO National Center of Oncological Hadrontherapy
PRS Account CNAO National Center of Oncological Hadrontherapy
Verification Date July 2020