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.
Bozlar U, Norton PT, Turba UC, Hagspiel KD Novel technique for evaluating complex pelvic arteriovenous malformations with catheter-directed subtracted MR angiography. J Vasc Interv Radiol. 2007 Jul;18(7):920-3. doi: 10.1016/j.jvir.2007.04.003.
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.
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.
Derbyshire JA, Herzka DA, McVeigh ER, Lederman RJ Efficient implementation of hardware-optimized gradient sequences for real-time imaging. Magn Reson Med. 2010 Dec;64(6):1814-20. doi: 10.1002/mrm.22211.
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.
Guttman MA, Dick AJ, Raman VK, Arai AE, Lederman RJ, McVeigh ER Imaging of myocardial infarction for diagnosis and intervention using real-time interactive MRI without ECG-gating or breath-holding. Magn Reson Med. 2004 Aug;52(2):354-61. doi: 10.1002/mrm.20174.
Huegli RW, Aschwanden M, Kos S, Rasmus M, Jaeger K, Jacob AL, Bilecen D Diagnostic pitfalls in postinterventional intraarterial magnetic resonance angiography after recanalization of femoropopliteal arterial occlusions. Acta Radiol. 2008 Dec;49(10):1129-36. doi: 10.1080/02841850802508942.
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.
Kuehne T, Yilmaz S, Schulze-Neick I, Wellnhofer E, Ewert P, Nagel E, Lange P Magnetic resonance imaging guided catheterisation for assessment of pulmonary vascular resistance: in vivo validation and clinical application in patients with pulmonary hypertension. Heart. 2005 Aug;91(8):1064-9. doi: 10.1136/hrt.2004.038265.
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.
Saikus CE, Lederman RJ Interventional cardiovascular magnetic resonance imaging: a new opportunity for image-guided interventions. JACC Cardiovasc Imaging. 2009 Nov;2(11):1321-31. doi: 10.1016/j.jcmg.2009.09.002.
Sampath S, Raval AN, Lederman RJ, McVeigh ER High-resolution 3D arteriography of chronic total peripheral occlusions using a T1-W turbo spin-echo sequence with inner-volume imaging. Magn Reson Med. 2007 Jan;57(1):40-9. doi: 10.1002/mrm.21098.
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.
Tello R, Mitchell PJ, Melhem ER, Witte D, Thomson KR Interventional catheter magnetic resonance angiography with a conventional 1.5-T magnet: work in progress. Australas Radiol. 1999 Nov;43(4):435-9. doi: 10.1046/j.1440-1673.1999.00706.x.
Interventional studies are often prospective and are specifically tailored to evaluate direct impacts of treatment or preventive measures on disease.
Observational studies are often retrospective and are used to assess potential causation in exposure-outcome relationships and therefore influence preventive methods.
Expanded access is a means by which manufacturers make investigational new drugs available, under certain circumstances, to treat a patient(s) with a serious disease or condition who cannot participate in a controlled clinical trial.
Clinical trials are conducted in a series of steps, called phases - each phase is designed to answer a separate research question.
Phase 1: Researchers test a new drug or treatment in a small group of people for the first time to evaluate its safety, determine a safe dosage range, and identify side effects.
Phase 2: The drug or treatment is given to a larger group of people to see if it is effective and to further evaluate its safety.
Phase 3: The drug or treatment is given to large groups of people to confirm its effectiveness, monitor side effects, compare it to commonly used treatments, and collect information that will allow the drug or treatment to be used safely.
Phase 4: Studies are done after the drug or treatment has been marketed to gather information on the drug's effect in various populations and any side effects associated with long-term use.