Patient Skin Dose in Interventional Radiology

NCT04246125 | Completed

• 2 other identifiers: APHP1910822019-A02411-56
• Study Type: observational
• Target: 87
• Locations: 1 country
• Sites: 5

Brief 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.

Conditions

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

Keywords

Dose archiving and communication systems; Dosimetry; Gafchromic film; Interventional radiology; Peak skin dose

Outcome Measures

Primary Outcomes (1)

• 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)

Study Arms (1)

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.

Procedure: Interventional radiology : skin dose measurements

Interventions

Interventional radiology : skin dose measurements PROCEDURE

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.

Therapeutic interventional radiology

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Adult patients (≥ 18 years old) for whom an interventional radiology procedure is performed

You may qualify if:

• 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

You may not qualify if:

• Patients \<18 years old
• Diagnostic interventional radiology procedure

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (5)

AP-HP, Bicêtre Hospital, Nuclear medicine department

Le Kremlin-Bicêtre, 94275, France

Location

AP-HP, Lariboisière Hospital, Cardiology department

Paris, 75010, France

Location

AP-HP, Lariboisière Hospital, Neuroradiology department

Paris, 75010, France

Location

AP-HP, Cochin Hospital, Radiology A department

Paris, 75014, France

Location

AP-HP, Necker-Enfants Malades Hospital, Pediatric radiology department

Paris, 75743, France

Location

Related Publications (29)

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  BACKGROUND

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MeSH Terms

Conditions

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

Condition Hierarchy (Ancestors)

Vascular Diseases; Cardiovascular Diseases; Vascular Malformations; Cardiovascular Abnormalities; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Coronary Disease; Myocardial Ischemia; Heart Diseases; Respiratory Tract Neoplasms; Thoracic Neoplasms; Neoplasms by Site; Neoplasms; Lung Diseases; Respiratory Tract Diseases; Digestive System Neoplasms; Digestive System Diseases; Liver Diseases

Study Officials

• 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

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: CROSS SECTIONAL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 27, 2020
• First Posted: January 29, 2020
• Study Start: October 13, 2020
• Primary Completion: June 7, 2022
• Study Completion: June 7, 2022
• Last Updated: February 16, 2023

Record last verified: 2023-02

Locations

FR (5)