XFM: (X-ray Fused With MRI) Guided Cardiac Catheterization

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ClinicalTrials.gov Identifier: NCT02737579

Recruitment Status : Active, not recruiting

First Posted : April 14, 2016

Last Update Posted : March 31, 2022

View this study on Beta.ClinicalTrials.gov

Sponsor:

Information provided by (Responsible Party):

Joshua Kanter, Children's National Research Institute

No Study Results Posted on ClinicalTrials.gov for this Study

About Study Results Reporting on ClinicalTrials.gov

Recruitment Status :	Active, not recruiting
Estimated Primary Completion Date :	December 31, 2024
Estimated Study Completion Date :	December 31, 2024

Publications:

de Silva R, Gutierrez LF, Raval AN, McVeigh ER, Ozturk C, Lederman RJ. X-ray fused with magnetic resonance imaging (XFM) to target endomyocardial injections: validation in a swine model of myocardial infarction. Circulation. 2006 Nov 28;114(22):2342-50. doi: 10.1161/CIRCULATIONAHA.105.598524. Epub 2006 Nov 13.

Gutierrez LF, Silva Rd, Ozturk C, Sonmez M, Stine AM, Raval AN, Raman VK, Sachdev V, Aviles RJ, Waclawiw MA, McVeigh ER, Lederman RJ. Technology preview: X-ray fused with magnetic resonance during invasive cardiovascular procedures. Catheter Cardiovasc Interv. 2007 Nov 15;70(6):773-82. doi: 10.1002/ccd.21352.

Faranesh AZ, Kellman P, Ratnayaka K, Lederman RJ. Integration of cardiac and respiratory motion into MRI roadmaps fused with x-ray. Med Phys. 2013 Mar;40(3):032302. doi: 10.1118/1.4789919.

George AK, Sonmez M, Lederman RJ, Faranesh AZ. Robust automatic rigid registration of MRI and X-ray using external fiducial markers for XFM-guided interventional procedures. Med Phys. 2011 Jan;38(1):125-41. doi: 10.1118/1.3523621.

Gutierrez LF, Ozturk C, McVeigh ER, Lederman RJ. A practical global distortion correction method for an image intensifier based x-ray fluoroscopy system. Med Phys. 2008 Mar;35(3):997-1007. doi: 10.1118/1.2839099.

Kleinerman RA. Cancer risks following diagnostic and therapeutic radiation exposure in children. Pediatr Radiol. 2006 Sep;36 Suppl 2(Suppl 2):121-5. doi: 10.1007/s00247-006-0191-5.

Andreassi MG, Ait-Ali L, Botto N, Manfredi S, Mottola G, Picano E. Cardiac catheterization and long-term chromosomal damage in children with congenital heart disease. Eur Heart J. 2006 Nov;27(22):2703-8. doi: 10.1093/eurheartj/ehl014. Epub 2006 May 22.

Beels L, Bacher K, De Wolf D, Werbrouck J, Thierens H. gamma-H2AX foci as a biomarker for patient X-ray exposure in pediatric cardiac catheterization: are we underestimating radiation risks? Circulation. 2009 Nov 10;120(19):1903-9. doi: 10.1161/CIRCULATIONAHA.109.880385. Epub 2009 Oct 26.

Schwartz GJ, Haycock GB, Edelmann CM Jr, Spitzer A. A simple estimate of glomerular filtration rate in children derived from body length and plasma creatinine. Pediatrics. 1976 Aug;58(2):259-63.

Kiringoda R, Thurm AE, Hirschtritt ME, Koziol D, Wesley R, Swedo SE, O'Grady NP, Quezado ZM. Risks of propofol sedation/anesthesia for imaging studies in pediatric research: eight years of experience in a clinical research center. Arch Pediatr Adolesc Med. 2010 Jun;164(6):554-60. doi: 10.1001/archpediatrics.2010.75.

Haustein J, Laniado M, Niendorf HP, Louton T, Beck W, Planitzer J, Schoffel M, Reiser M, Kaiser W, Schorner W, et al. Triple-dose versus standard-dose gadopentetate dimeglumine: a randomized study in 199 patients. Radiology. 1993 Mar;186(3):855-60. doi: 10.1148/radiology.186.3.8430199.

Niendorf HP, Alhassan A, Geens VR, Clauss W. Safety review of gadopentetate dimeglumine. Extended clinical experience after more than five million applications. Invest Radiol. 1994 Jun;29 Suppl 2:S179-82. doi: 10.1097/00004424-199406001-00059. No abstract available.

Niendorf HP, Dinger JC, Haustein J, Cornelius I, Alhassan A, Clauss W. Tolerance data of Gd-DTPA: a review. Eur J Radiol. 1991 Jul-Aug;13(1):15-20. doi: 10.1016/0720-048x(91)90049-2.

Niendorf HP, Haustein J, Cornelius I, Alhassan A, Clauss W. Safety of gadolinium-DTPA: extended clinical experience. Magn Reson Med. 1991 Dec;22(2):222-8; discussion 229-32. doi: 10.1002/mrm.1910220212.

Niendorf HP, Haustein J, Louton T, Beck W, Laniado M. Safety and tolerance after intravenous administration of 0.3 mmol/kg Gd-DTPA. Results of a randomized, controlled clinical trial. Invest Radiol. 1991 Nov;26 Suppl 1:S221-3; discussion S232-5. doi: 10.1097/00004424-199111001-00075. No abstract available.

Dillman JR, Ellis JH, Cohan RH, Strouse PJ, Jan SC. Frequency and severity of acute allergic-like reactions to gadolinium-containing i.v. contrast media in children and adults. AJR Am J Roentgenol. 2007 Dec;189(6):1533-8. doi: 10.2214/AJR.07.2554.

Sundgren PC, Leander P. Is administration of gadolinium-based contrast media to pregnant women and small children justified? J Magn Reson Imaging. 2011 Oct;34(4):750-7. doi: 10.1002/jmri.22413.

Deo A, Fogel M, Cowper SE. Nephrogenic systemic fibrosis: a population study examining the relationship of disease development to gadolinium exposure. Clin J Am Soc Nephrol. 2007 Mar;2(2):264-7. doi: 10.2215/CJN.03921106. Epub 2007 Feb 7.

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