Cho YH, Cho KR, Park EK, Seo BK, Woo OH, Cho SB, Bae JW Significance of Additional Non-Mass Enhancement in Patients with Breast Cancer on Preoperative 3T Dynamic Contrast Enhanced MRI of the Breast. Iran J Radiol. 2016 Jan 23;13(1):e30909. doi: 10.5812/iranjradiol.30909. eCollection 2016 Jan.
Ha GW, Yi MS, Lee BK, Youn HJ, Jung SH Clinical outcome of magnetic resonance imaging-detected additional lesions in breast cancer patients. J Breast Cancer. 2011 Sep;14(3):213-8. doi: 10.4048/jbc.2011.14.3.213. Epub 2011 Sep 29.
Lee SM, Nam KJ, Choo KS, Kim JY, Jeong DW, Kim HY, Kim JY Patterns of malignant non-mass enhancement on 3-T breast MRI help predict invasiveness: using the BI-RADS lexicon fifth edition. Acta Radiol. 2018 Nov;59(11):1292-1299. doi: 10.1177/0284185118759139. Epub 2018 May 14.
Machida Y, Shimauchi A, Tozaki M, Kuroki Y, Yoshida T, Fukuma E Descriptors of Malignant Non-mass Enhancement of Breast MRI: Their Correlation to the Presence of Invasion. Acad Radiol. 2016 Jun;23(6):687-95. doi: 10.1016/j.acra.2016.01.014. Epub 2016 Mar 11.
Park SY, Han BK, Ko ES, Ko EY, Cho EY Additional lesions seen in magnetic resonance imaging of breast cancer patients: the role of second-look ultrasound and imaging-guided interventions. Ultrasonography. 2019 Jan;38(1):76-82. doi: 10.14366/usg.18002. Epub 2018 Jun 23.
Shin K, Phalak K, Hamame A, Whitman GJ Interpretation of Breast MRI Utilizing the BI-RADS Fifth Edition Lexicon: How Are We Doing and Where Are We Headed? Curr Probl Diagn Radiol. 2017 Jan - Feb;46(1):26-34. doi: 10.1067/j.cpradiol.2015.12.001. Epub 2015 Dec 15. Review.
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.
