Ignite Creation Date:
2025-12-25 @ 1:27 AM
Ignite Modification Date:
2025-12-27 @ 10:57 PM
Study NCT ID:
NCT04048694
Status:
COMPLETED
Last Update Posted:
2019-08-07
First Post:
2016-09-08
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Comparative Study of Calculating the X-ray Dose to the Skin of the Patient Exposed
Sponsor:
University Hospital, Brest
Organization:
Study Overview
Official Title:
Comparative Study of Calculating the Dose to the Skin by the Dosemap® Software and Its Measurement in Vivo by Gafchromic Movie
Status:
COMPLETED
Status Verified Date:
2019-08
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
DOSEMAP
Brief Summary:
The main objective is to estimate the precision of the calculation by the software DoseMap ® towards the in vivo measure by gafchromic movie.
Detailed Description:
The procedures of Interventional Cardiology are realized under exposure in the X-rays which can be sometimes important for the patient according to the nature of the procedure.
The estimation of the dose in the skin following a procedure of interventional cardiology is difficult. The knowledge of this dose allows to anticipate the appearance of determinist effects, and so to activate a dermatological follow-up of the exposed patient in case of overtaking of a dose threshold. Unfortunately, it is impossible to measure it directly and the thresholds of exposures are fixed from the measure of the kerma in the air accumulated at the exit of the tube with X-ray, what remains very indistinct.
Since a few years the manufacturers propose tools allowing an estimation of the dose the skin of the patient. The DoseMap software ® allows to consider this dose from the data of exposure supplied by the system. To do it, it uses a modelling simplified of the patient to feign the deposit of dose in the latter.
It seems to us interesting to verify the precision of this simulation by comparing it with a measure of the in vivo dose.
The estimation of the dose in the skin following a procedure of interventional cardiology is difficult. The knowledge of this dose allows to anticipate the appearance of determinist effects, and so to activate a dermatological follow-up of the exposed patient in case of overtaking of a dose threshold. Unfortunately, it is impossible to measure it directly and the thresholds of exposures are fixed from the measure of the kerma in the air accumulated at the exit of the tube with X-ray, what remains very indistinct.
Since a few years the manufacturers propose tools allowing an estimation of the dose the skin of the patient. The DoseMap software ® allows to consider this dose from the data of exposure supplied by the system. To do it, it uses a modelling simplified of the patient to feign the deposit of dose in the latter.
It seems to us interesting to verify the precision of this simulation by comparing it with a measure of the in vivo dose.
Study Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: