Patient Skin Dose in Interventional Radiology

  • STATUS
    Recruiting
  • End date
    Apr 13, 2024
  • participants needed
    150
  • sponsor
    Assistance Publique - Hôpitaux de Paris
Updated on 13 March 2021

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.

Description

Methodology

The study will consist of:

  • Placing a rectangular dosimeter film (dimensions: 21 x 30 cm, 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.

Details
Condition Pulmonary Disease, Lung Disease, Vascular Diseases, Vascular Diseases, LIVER DISEASE, LIVER DISEASE, Liver Disorders, Coronary Occlusion, Lung Neoplasm, Lung Cancer, HEPATIC NEOPLASM, Liver Cancer, Neoplasm of unspecified nature of digestive system, Digestive System Neoplasms, Arteriovenous malformation, Abnormal Blood Vessels (Arteriovenous Malformations), Aneurysm, Aneurysm, Abnormal Blood Vessels (Arteriovenous Malformations), Lung Cancer, Liver Cancer, Lung Disease, Liver Disorders, Digestive System Neoplasms, coronary artery occlusion, hepatoma, tumor liver, liver tumor, liver tumours, arteriovenous malformations, aneurysms, lung tumor
Treatment Interventional radiology : skin dose measurements
Clinical Study IdentifierNCT04246125
SponsorAssistance Publique - Hôpitaux de Paris
Last Modified on13 March 2021

Eligibility

Yes No Not Sure

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
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