Clinical trial NCT04246125: Patient Skin Dose in Interventional Radiology
Official title: Evaluation of the Patient Skin Dose in Interventional Radiology
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Aneurysm
Arteriovenous Malformations
Coronary Occlusion
Lung Neoplasms
Liver Neoplasms
Keywords: Dose archiving and communication systems
Dosimetry
Gafchromic film
Interventional radiology
Peak skin dose
Lead sponsor: Assistance Publique - Hôpitaux de Paris
Sponsor class: OTHER
First posted: 2020-01-29
Enrollment: 87
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Adult patients (≥ 18 years old) for whom an interventional radiology procedure is performed

Brief summary: Studies on radiation induced patients' skin lesions in interventional radiology highlighted the need for optimized and personalized patient dosimetry and adapted patient follow-up. Measurements using Gafchromic® films or thermoluminescent dosimeters have long been the only way to accurately evaluate the maximum absorbed dose to the patient skin. However as these dose measurements are tedious and expensive, they could not be systematically applicable in clinical practice. Therefore, more practical calculation methods have been developed. These software programs calculate the skin dose using dosimetric information from images DICOM header or radiation dose structured reports (RDSRs). Validation studies of these software programs are rare and when existent have many limitations.

Radiation Dose Monitor (RDM from Medsquare) is a software program for archiving and monitoring of radiation dose (DACS, Dosimetry Archiving Communication System) used in routine in the investigator's hospitals. A new functionality developed in RDM allows quick estimation without in-vivo measurements of the absorbed dose to the skin of the patient. Comparing RDM calculations with in-vivo measurements will enable this software validation so that it can be used in clinical routine.

Main objective: to validate RDM software for calculating patient skin dose in interventional radiology.

Detailed description: Methodology:

The study will consist of:

* Placing a rectangular dosimeter film (dimensions: 21 x 30 cm², 1mm thick) on the examination table under the sheet before installing the patient. This film is then read using a desktop scanner and specific software to determine the absorbed dose to the patient's skin. The film is not in direct contact with the patient and will not modify the standard procedure of interventional radiology.
* Collecting the weight and height of the patient
* Collecting the dosimetric information indicated in the dose report (RDSR) generated by the radiology equipment and automatically sent to the RDM DACS server at the end of the procedure (air kerma at the interventional reference point, dose area product, fluoroscopy time, X-ray tube, table and detector positions, field size, beam filtration, high voltage kV and mA current). This data is currently archived in a regulatory way, without modifying the usual patients' care pathway. This dosimetric information in addition to the technical information related to the equipment (radiology equipment brand and model, kerma calibration factor, examination table and mattress thickness) will be used as input data to the RDM software for skin dose calculations.

These last two points are realized in the classic framework of the patient care pathway and do not modify the standard procedure.

The comparison between measured and calculated absorbed dose for the validation of the calculation software will be done anonymously. The information collected does not permit the patient identification.

Eligibility criteria: Inclusion Criteria:

* Adult patients (≥ 18 years old) who have a therapeutic interventional radiology procedure for the following anatomical regions:

  * cerebral (neuroradiology)
  * thoracic (cardiology, lungs)
  * abdominal
* Patient informed and having expressed his non-opposition to participate in the research

Exclusion Criteria:

* Patients \<18 years old
* Diagnostic interventional radiology procedure
* Demented patients unable to receive information regarding their inclusion in the research protocol.

Primary outcomes:
measure: Maximum absorbed skin dose and dose distribution
timeFrame: Standard duration of the interventional radiology procedure carried out as part of usual care (maximum of 8 hours)
Secondary outcomes:
Other outcomes:
Locations:
city: Le Kremlin-Bicêtre
country: France
facility: AP-HP, Bicêtre Hospital, Nuclear medicine department
city: Paris
country: France
facility: AP-HP, Lariboisière Hospital, Cardiology department
city: Paris
country: France
facility: AP-HP, Lariboisière Hospital, Neuroradiology department
city: Paris
country: France
facility: AP-HP, Cochin Hospital, Radiology A department
city: Paris
country: France
facility: AP-HP, Necker-Enfants Malades Hospital, Pediatric radiology department
Study officials:
affiliation: AP-HP, Lariboisière hospital
name: Lama HADID-BEURRIER, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AP-HP, Cochin hospital
name: Catherine BOUCHARD
role: PRINCIPAL_INVESTIGATOR
affiliation: AP-HP, Necker hospital
name: Bouchra HABIB GERYES, PhD
role: PRINCIPAL_INVESTIGATOR
affiliation: AP-HP, Bicêtre hospital
name: Joëlle Ann FEGHALI, PhD
role: PRINCIPAL_INVESTIGATOR
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