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

• ClinicalTrials.gov Identifier: NCT02737579
• Recruitment Status: Active, not recruiting
• First Posted: April 14, 2016
• Last Update Posted: March 31, 2022
• Sponsor: Joshua Kanter
• Information provided by (Responsible Party): Joshua Kanter, Children's National Research Institute

Tracking Information

• First Submitted Date: February 17, 2016
• First Posted Date: April 14, 2016
• Last Update Posted Date: March 31, 2022
• Actual Study Start Date: July 23, 2013
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures (submitted: April 11, 2016)

Radiation exposure measurement [ Time Frame: At the end of each catheterization procedure through study completion,up to 8 years. ]

Comparisons with data from historical controls undergoing matched invasive cardiology procedures at Children's National Medical Center

• Original Primary Outcome Measures: Same as current

Current Secondary Outcome Measures (submitted: April 11, 2016)

• Fluoroscopy time measurement [ Time Frame: At the end of each catheterization procedure through study completion,up to 8 years. ]
  Comparisons with data from historical controls undergoing matched procedures at Children's National Medical Center
• Contrast volume measurement [ Time Frame: At the end of each catheterization procedure through study completion, up to 8 years. ]
  Comparisons with data from historical controls undergoing matched invasive cardiology procedures at Children's National Medical Center will be examined.
• Procedure time measurement [ Time Frame: At the end of each catheterization procedure through study completion,up to 8 years. ]
  Comparisons with data from historical controls undergoing matched procedures at Children's National Medical Center

• Original Secondary Outcome Measures: Same as current
• Current Other Pre-specified Outcome Measures: Not Provided
• Original Other Pre-specified Outcome Measures: Not Provided

Descriptive Information

• Brief Title: XFM: (X-ray Fused With MRI) Guided Cardiac Catheterization
• Official Title: XFM: (X-ray Fused With MRI) Guided Cardiac Catheterization
• Brief Summary: This study will evaluate the use of x-ray fused with MR images as an imaging tool to help guide catheter tools during diagnostic and therapeutic cardiac catheterization procedures.

Detailed Description

Cardiovascular interventional procedures are currently conducted under the guidance of X-ray fluoroscopy. Magnetic resonance imaging (MRI) can provide increased soft tissue information about the cardiovascular system. By combining the familiar X-ray environment with superior magnetic resonance imaging, the investigator hopes to enhance and expand the capabilities of cardiac catheterization techniques.

The investigator will conduct cardiac catheterization procedures using XFM guidance in pediatric research patients who are undergoing medically necessary procedures. The investigator aims to decrease the exposure of these patients to the routine hazards of ionizing radiation and contrast exposure compared to the standard of care approach.

• Study Type: Interventional
• Study Phase: Not Applicable
• Study Design: Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Diagnostic
• Condition: Congenital Heart Defect

Intervention

Procedure: XFM guidance

X-ray images and MRI roadmaps are aligned, during the medically indicated catheterization procedure, both conventional X-ray and investigational XFM images are displayed side-by-side. The operator may choose to be guided by either.

Study Arms

XFM guidance

X-ray fused cardiac MRI images used for guidance tool to perform cardiac catheterization procedure

Intervention: Procedure: XFM guidance

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.

Recruitment Information

• Recruitment Status: Active, not recruiting
• Actual Enrollment (submitted: October 14, 2019): 27
• Original Estimated Enrollment (submitted: April 11, 2016): 200
• Estimated Study Completion Date: December 31, 2024
• Estimated Primary Completion Date: December 31, 2024 (Final data collection date for primary outcome measure)

Eligibility Criteria

Inclusion Criteria:

1. Children and adults of any age
2. Undergoing clinically-indicated cardiovascular catheterization

Exclusion Criteria:

1. Cardiovascular instability precluding baseline medially-necesary MRI
2. Women who are pregnant
3. Women who are nursing and who do not plan to discard breast milk for 24 hours
4. All patients who are medically judged to have contraindication(s) to MRI scanning. Contraindications include implanted metal devices which are contraindicated for MRI scanning

Sex/Gender

• Sexes Eligible for Study: All

• Ages: Child, Adult, Older Adult
• Accepts Healthy Volunteers: No
• Contacts: Contact information is only displayed when the study is recruiting subjects
• Listed Location Countries: United States

Administrative Information

• NCT Number: NCT02737579
• Other Study ID Numbers: 3879; Internal Bridge Funding ( Other Grant/Funding Number: Children's Research Institute, Children's National )
• Has Data Monitoring Committee: No
• U.S. FDA-regulated Product: Not Provided

IPD Sharing Statement

• Plan to Share IPD: No

• Current Responsible Party: Joshua Kanter, Children's National Research Institute
• Original Responsible Party: Same as current
• Current Study Sponsor: Joshua Kanter
• Original Study Sponsor: Same as current
• Collaborators: Not Provided

Investigators

• Principal Investigator: Joshua Kanter, MD; Children's National Hospital System

• PRS Account: Children's National Research Institute
• Verification Date: March 2022