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| ID | Type | Description | Link |
|---|---|---|---|
| 2019-A02411-56 | Other Identifier | IDRCB |
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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.
Methodology:
The study will consist of:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeutic interventional radiology | Patients undergoing an interventional radiology procedure, at risk for developing radiation-induced skin lesions, including acts of therapeutic interventional neuroradiology (angioplasties, embolization of aneurysms, embolization of arteriovenous malformations , etc…), embolizations and ablations of thoracic tumors, therapeutic cardiac acts (transluminal angioplasties and chronic coronary occlusions) and abdominal embolizations. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Interventional radiology : skin dose measurements | Procedure | Therapeutic interventional radiology procedure for the following anatomical regions:
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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) |
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Inclusion Criteria:
Adult patients (≥ 18 years old) who have a therapeutic interventional radiology procedure for the following anatomical regions:
Patient informed and having expressed his non-opposition to participate in the research
Exclusion Criteria:
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Adult patients (≥ 18 years old) for whom an interventional radiology procedure is performed
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| Name | Affiliation | Role |
|---|---|---|
| Lama HADID-BEURRIER, PhD | AP-HP, Lariboisière hospital | Principal Investigator |
| Catherine BOUCHARD | AP-HP, Cochin hospital | Principal Investigator |
| Bouchra HABIB GERYES, PhD | AP-HP, Necker hospital | Principal Investigator |
| Joëlle Ann FEGHALI, PhD | AP-HP, Bicêtre hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| AP-HP, Bicêtre Hospital, Nuclear medicine department | Le Kremlin-Bicêtre | 94275 | France | |||
| AP-HP, Lariboisière Hospital, Cardiology department |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| Background | Food and Drug Administration (FDA). Avoidance of serious x-ray-induced skin injuries to patients during fluoroscopically-guided procedures, 1994. | ||
| 11459599 | Background | Valentin J. Avoidance of radiation injuries from medical interventional procedures. Ann ICRP. 2000;30(2):7-67. doi: 10.1016/S0146-6453(01)00004-5. | |
| 24077043 |
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| ID | Term |
|---|---|
| D000783 | Aneurysm |
| D001165 | Arteriovenous Malformations |
| D054059 | Coronary Occlusion |
| D008175 | Lung Neoplasms |
| D008113 | Liver Neoplasms |
| ID | Term |
|---|---|
| D014652 | Vascular Diseases |
| D002318 | Cardiovascular Diseases |
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
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|
| Paris |
| 75010 |
| France |
| AP-HP, Lariboisière Hospital, Neuroradiology department | Paris | 75010 | France |
| AP-HP, Cochin Hospital, Radiology A department | Paris | 75014 | France |
| AP-HP, Necker-Enfants Malades Hospital, Pediatric radiology department | Paris | 75743 | France |
| Background |
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| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D003327 | Coronary Disease |
| D017202 | Myocardial Ischemia |
| D006331 | Heart Diseases |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
| D004067 | Digestive System Neoplasms |
| D004066 | Digestive System Diseases |
| D008107 | Liver Diseases |