Patient Skin Dose in Interventional Radiology

Lung Neoplasms Clinical Trial

— DPPRI  

Official title:

Evaluation of the Patient Skin Dose in Interventional Radiology

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04246125
• Other study ID #: APHP191082
• Secondary ID: 2019-A02411-56
• Status: Completed
• Start date: October 13, 2020
• Est. completion date: June 7, 2022

Study information

• Verified date: February 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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 cm², 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 87
• Est. completion date: June 7, 2022
• Est. primary completion date: June 7, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Aneurysm
• Arteriovenous Malformations
• Coronary Occlusion
• Liver Neoplasms
• Lung Neoplasms
• Neoplasms

Intervention

Procedure:
• Interventional radiology : skin dose measurements
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.

Locations

Country	Name	City	State
France	AP-HP, Bicêtre Hospital, Nuclear medicine department	Le Kremlin-Bicêtre
France	AP-HP, Cochin Hospital, Radiology A department	Paris
France	AP-HP, Lariboisière Hospital, Cardiology department	Paris
France	AP-HP, Lariboisière Hospital, Neuroradiology department	Paris
France	AP-HP, Necker-Enfants Malades Hospital, Pediatric radiology department	Paris

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

References & Publications (29)

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Giordano C, D'Ercole L, Gobbi R, Bocchiola M, Passerini F. Coronary angiography and percutaneous transluminal coronary angioplasty procedures: Evaluation of patients' maximum skin dose using Gafchromic films and a comparison of local levels with reference levels proposed in the literature. Phys Med. 2010 Oct;26(4):224-32. doi: 10.1016/j.ejmp.2010.01.001. Epub 2010 Feb 8. — View Citation

Greffier J, Van Ngoc Ty C, Agelou M, Coulot J, Ledermann B, Ovtchinnikoff S, Pereira F, Beregi JP, Bonniaud G. Impact of the calibration conditions of XR-RV3 films on peak skin dose measurements in interventional radiology. Radiat Prot Dosimetry. 2017 Apr 25;174(2):207-215. doi: 10.1093/rpd/ncw116. — View Citation

Greffier J, Van Ngoc Ty C, Bonniaud G, Moliner G, Ledermann B, Schmutz L, Cornillet L, Cayla G, Beregi JP, Pereira F. Assessment of peak skin dose in interventional cardiology: A comparison between Gafchromic film and dosimetric software em.dose. Phys Med. 2017 Jun;38:16-22. doi: 10.1016/j.ejmp.2017.05.044. Epub 2017 May 8. — View Citation

IEC 61267. Medical Diagnostic X-ray Equipment - Radiation Conditions for Use in the Determination of Characteristics, 2005.

IEC/PAS 61910-1. Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured report for radiography and radioscopy, 2014.

Johnson PB, Borrego D, Balter S, Johnson K, Siragusa D, Bolch WE. Skin dose mapping for fluoroscopically guided interventions. Med Phys. 2011 Oct;38(10):5490-9. doi: 10.1118/1.3633935. — View Citation

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Khodadadegan Y, Zhang M, Pavlicek W, Paden RG, Chong B, Huettl EA, Schueler BA, Fetterly KA, Langer SG, Wu T. Validation and initial clinical use of automatic peak skin dose localization with fluoroscopic and interventional procedures. Radiology. 2013 Jan;266(1):246-55. doi: 10.1148/radiol.12112295. Epub 2012 Nov 9. — View Citation

Khodadadegan Y, Zhang M, Pavlicek W, Paden RG, Chong B, Schueler BA, Fetterly KA, Langer SG, Wu T. Automatic monitoring of localized skin dose with fluoroscopic and interventional procedures. J Digit Imaging. 2011 Aug;24(4):626-39. doi: 10.1007/s10278-010-9320-7. — View Citation

Magnier F, Poulin M, Van Ngoc Ty C, Osmond E, Bonniaud G, Coulot J, Pereira B, Boyer L, Guersen J, Cassagnes L. Comparison of Patient Skin Dose Evaluated Using Radiochromic Film and Dose Calculation Software. Cardiovasc Intervent Radiol. 2018 May;41(5):762-771. doi: 10.1007/s00270-018-1888-1. Epub 2018 Feb 7. — View Citation

McCabe BP, Speidel MA, Pike TL, Van Lysel MS. Calibration of GafChromic XR-RV3 radiochromic film for skin dose measurement using standardized x-ray spectra and a commercial flatbed scanner. Med Phys. 2011 Apr;38(4):1919-30. doi: 10.1118/1.3560422. — View Citation

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Rana VK, Rudin S, Bednarek DR. A tracking system to calculate patient skin dose in real-time during neurointerventional procedures using a biplane x-ray imaging system. Med Phys. 2016 Sep;43(9):5131. doi: 10.1118/1.4960368. — View Citation

Sanchez RM, Vano E, Fernandez JM, Escaned J. Evaluation of a real-time display for skin dose map in cardiac catheterisation procedures. Radiat Prot Dosimetry. 2015 Jul;165(1-4):240-3. doi: 10.1093/rpd/ncv033. Epub 2015 Mar 18. — View Citation

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Ying CK, Kandaiya S. Patient skin dose measurements during coronary interventional procedures using Gafchromic film. J Radiol Prot. 2010 Sep;30(3):585-96. doi: 10.1088/0952-4746/30/3/012. Epub 2010 Sep 8. — View Citation

* Note: There are 29 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Maximum absorbed skin dose and dose distribution	Measurement of the maximum absorbed dose value and dose mapping by the Gafchromic® film dosimeter (in-vivo measurements within interventional radiology procedure). Comparison between measured and calculated values by the RDM software.	Standard duration of the interventional radiology procedure carried out as part of usual care (maximum of 8 hours)