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

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT04048694
Acronym
DOSEMAP
Enrollment
100
Registered
2019-08-07
Start date
2016-04-11
Completion date
2016-10-27
Last updated
2019-08-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Measure of the X-ray Dose

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.

Interventions

None listed

Sponsors

University Hospital, Brest
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frame
Difference between the calculation by the software and the measurement by the dosimetry film6 months

Countries

France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026