CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 87 enrolled
Drug / intervention
Interventional radiology : skin dose measurementsprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT04246125
NCT04246125N/ACompleted

Evaluation of the Patient Skin Dose in Interventional Radiology

Assistance Publique - Hôpitaux de Paris·observational·Posted Jan 29, 2020·Updated Feb 16, 2023

In Brief

An observational study evaluating Interventional radiology : skin dose measurements for Aneurysm and 4 related conditions. Completed, enrolled 87 participants across 5 sites.

Detailed 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.

Study Details

Study Typeobservational
Allocation--
Masking--
Primary Purpose--
CountriesFrance
Collaborators--

Timeline

N/ACompletedFinished
2020202120222023202420252026
First PostedJan 29, 2020
Enrollment StartOct 13, 2020
Primary CompletionJun 7, 2022
TodayJul 2, 2026
Enrollment to primary: 1.7 yearsPosted 6.4 years ago

Interventions

Interventional radiology : skin dose measurementsprocedure

Therapeutic interventional radiology procedure for the following anatomical regions: * cerebral (neuroradiology) * thoracic (cardiology, lungs) * abdominal Assessment of peak skin dose and dose mapping with use of Gafchromic film dosimeter and the estimation of the absorbed dose to the skin with use of RDM software program.