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AneurysmDPPRINCT04246125

Patient Skin Dose in Interventional Radiology

An observational study of Aneurysm and Arteriovenous Malformations, run by Assistance Publique - Hôpitaux de Paris at 5 sites in France.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
Interventional radiology : skin dose measurements
Type of treatment
Surgery or procedure
How many people
87 participants
Where
5 sitesFrance
Study dates
13 Oct 2020to 7 Jun 2022
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

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

Who may be able to join

  • 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

Who cannot join

  • Patients <18 years old
  • Diagnostic interventional radiology procedure
  • Demented patients unable to receive information regarding their inclusion in the research protocol.

Trial locations and contacts

5 sites in 1 country.

5 sites in 1 country

France5 sites

  • AP-HP, Bicêtre Hospital, Nuclear medicine department

    Le Kremlin-Bicêtre, 94275

  • AP-HP, Lariboisière Hospital, Cardiology department

    Paris, 75010

  • AP-HP, Lariboisière Hospital, Neuroradiology department

    Paris, 75010

  • AP-HP, Cochin Hospital, Radiology A department

    Paris, 75014

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

    Paris, 75743

Other trials in France

About this study

Official title: Evaluation of the Patient Skin Dose in Interventional Radiology

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.

Read the detailed 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.

Being tested
Interventional radiology : skin dose measurements
Keywords
Dose archiving and communication systems, Dosimetry, Gafchromic film, Interventional radiology, Peak skin dose
Medical subject headings
Aneurysm, Arteriovenous Malformations, Coronary Occlusion, Lung Neoplasms, Liver Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Interventional radiology : skin dose measurementsProcedure or surgery

    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.

Study groups in NCT04246125
Study groupRoleWhat they receive
Therapeutic interventional radiologyPatients 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.
Receives: Procedure: Interventional radiology : skin dose measurements

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: Standard duration of the interventional radiology procedure carried out as part of usual care (maximum of 8 hours)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted29 Jan 2020
  2. Study start13 Oct 2020
  3. Primary completion7 Jun 2022
  4. Study completion7 Jun 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Cross-sectional
Enrolment
87 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04246125
Sponsor's protocol ID
APHP191082
Other IDs
2019-A02411-56
Acronym
DPPRI
Status last verified
Feb 2023
First submitted
27 Jan 2020
Last updated
16 Feb 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Food and Drug Administration (FDA). Avoidance of serious x-ray-induced skin injuries to patients during fluoroscopically-guided procedures, 1994.

  • 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.

    PubMed 11459599

  • Miller DL. Efforts to optimize radiation protection in interventional fluoroscopy. Health Phys. 2013 Nov;105(5):435-44. doi: 10.1097/HP.0b013e31829c355a.

    PubMed 24077043

  • Bor D, Olgar T, Toklu T, Caglan A, Onal E, Padovani R. Patient doses and dosimetric evaluations in interventional cardiology. Phys Med. 2009 Mar;25(1):31-42. doi: 10.1016/j.ejmp.2008.03.002. Epub 2008 Apr 25.

    PubMed 18440265

  • 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.

    PubMed 20826892

  • 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.

    PubMed 20117030

  • den Boer A, de Feijter PJ, Serruys PW, Roelandt JR. Real-time quantification and display of skin radiation during coronary angiography and intervention. Circulation. 2001 Oct 9;104(15):1779-84. doi: 10.1161/hc4001.097057.

    PubMed 11591614

  • Balter S. Methods for measuring fluoroscopic skin dose. Pediatr Radiol. 2006 Sep;36 Suppl 2(Suppl 2):136-40. doi: 10.1007/s00247-006-0193-3.

    PubMed 16862416

  • Chida K, Kagaya Y, Saito H, Takai Y, Takahashi S, Yamada S, Kohzuki M, Zuguchi M. Total entrance skin dose: an effective indicator of maximum radiation dose to the skin during percutaneous coronary intervention. AJR Am J Roentgenol. 2007 Oct;189(4):W224-7. doi: 10.2214/AJR.07.2422.

    PubMed 17885036

  • 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.

    PubMed 20706859

  • 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.

    PubMed 25788618

  • Digital Imaging and Communications in Medicine (DICOM). Supplement 94: Diagnostic X-Ray radiation Dose Reporting (Dose SR), 2005.

  • 1IEC/PAS 61910-1. Medical electrical equipment - Radiation dose documentation - Part 1: Radiation dose structured report for radiography and radioscopy, 2007.

  • 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.

    PubMed 21992367

Questions about this trial

What is this clinical trial studying?

An observational study of Aneurysm and Arteriovenous Malformations, run by Assistance Publique - Hôpitaux de Paris at 5 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 16 Feb 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 5 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Maximum absorbed skin dose and dose distribution (time frame: Standard duration of the interventional radiology procedure carried out as part of usual care (maximum of 8 hours)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT04246125, which also lists 29 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 16 Feb 2023.

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