Comparative Study of Calculating the X-ray Dose to the Skin of the Patient Exposed

Measure of the X-ray Dose Clinical Trial

— DOSEMAP  

Official title:

Comparative Study of Calculating the Dose to the Skin by the Dosemap® Software and Its Measurement in Vivo by Gafchromic Movie

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04048694
• Other study ID #: DOSEMAP
• Status: Completed
• Start date: April 11, 2016
• Est. completion date: October 27, 2016

Study information

• Verified date: August 2019
• Source: University Hospital, Brest
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The main objective is to estimate the precision of the calculation by the software DoseMap ® towards the in vivo measure by gafchromic movie.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 27, 2016
• Est. primary completion date: October 27, 2016
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Procedure of Interventional Cardiology potentially more irradiant (angioplasty of the circumflex artery , or of several vessels)

• Body mass index > 25

• Collection of the Non-opposition of the patient

Exclusion Criteria:

• Diagnostic coronarography,

• Emergency procedures,

• Minor patients

Related Conditions & MeSH terms

• Measure of the X-ray Dose

Locations

Country	Name	City	State
France	CHRU de Brest	Brest

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Brest

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference between the calculation by the software and the measurement by the dosimetry film		6 months