Lung Neoplasms Clinical Trial
— DPPRIOfficial title:
Evaluation of the Patient Skin Dose in Interventional Radiology
Verified date | February 2023 |
Source | Assistance Publique - Hôpitaux de Paris |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Observational |
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.
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. |
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 |
Lead Sponsor | Collaborator |
---|---|
Assistance Publique - Hôpitaux de Paris |
France,
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* Note: There are 29 references in all — Click here to view all references
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) |
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