CT-guided percutaneous lung biopsy: are lesions closer to the diaphragm more likely for failure and complications?

No. 379 CT-guided percutaneous lung biopsy: are lesions closer to the diaphragm more likely for failure and complications? M.V. Patel, O. Ahmed, D. Jilani, S. Zangan; University of Chicago Hospitals, Chicago, IL Purpose: CT-guided percutaneous lung biopsy is a valuable tool in the diagnosis and management of pulmonary nodules and masses. However, the procedure is occasionally unsuccessful and carries risks such as pneumothorax. Lesions closer to the diaphragm may be more technically challenging secondary to respiratory motion and proximity to critical mediastinal structures. The objective of this study is to determine the impact of lesion proximity to the diaphragm on biopsy yield and complication rates. Materials and Methods: An IRB approved retrospective review of all CT-guided percutaneous lung biopsies at a single institution performed between August 1st, 2011 and July 31st, 2013 yielded 184 patients who underwent a total of 190 lung biopsies. The shortest distance of the target lesion from the diaphragm was measured on preprocedure sagittal reformatted CT images. Pathology and 2-hour post-procedure chest radiograph results were then collected from these patients. Results: The average distance of the target lesion from the diaphragm was 8.2cm. Nondiagnostic pathology results occurred in 29 patients (15%). For every 5cm closer to the diaphragm, the odds of nondiagnostic pathology result of a target lesion increase by 52% (p1⁄40.042). The odds of postbiopsy pneumothorax were not significantly different for lesions based on their distance from the diaphragm. These relationships held true when controlling for patient demographic parameters, presence of emphysema, cavitary nature of the target lesion and needle gauge. Conclusion: In our study the odds of nondiagnostic biopsy increased for lesions closer to the diaphragm but the odds of complications were not affected. This information can be useful in determining the likelihood of success of percutaneous lung biopsy. When multiple lesions are present, assuming other parameters are equivalent, targeting nodules or masses farther away from the diaphragm may improve diagnostic yield without increasing complications. Educational Exhibit Abstract No. 380 The ABCs of the FDA: a primer on the role of the FDA in medical device approvals and interventional radiology-related research A. Adamovich, S.J. Park, G. Siskin, M. Englander, K. Mandato, A. Herr, L. Keating; Radiology, Albany Medical Center, Albany, NY Learning Objectives: The learning objectives for this educational exhibit include (1) reviewing the history of the FDA and its role in medical device regulation, (2) outlining the FDA processes for medical device approval and investigational device exemptions, (3) discussing the potential role of the FDA in Interventional Radiology-related research. Background: Since the early 1900s, the FDA has played an important role in the regulation of drugs. Beginning in 1938, the FDA began regulating devices, culminating in the 1976 Medical Device Amendments, which initiated the current system of device development and approval. This is of particular relevance to device-driven specialties such as Interventional Radiology. With the passage of the Affordable Care Act, the cost and effectiveness of procedures is coming under increasing scrutiny. The data necessary to support the use of procedures falling under the domain of Interventional Radiology requires well-designed, prospective clinical trials. Interventional radiologists interested in performing this research must have an understanding of the FDA and its role in device regulation and device-related research. Clinical Findings/Procedure Details: Research in Interventional Radiology typically requires interaction with the FDA. Whether it is through industry-sponsored device trials during the approval process for new devices or investigator-initiated research prospectively evaluating the role of existing, significant-risk devices for new or established procedures, interaction with the FDA is an integral part of performing significant research in IR. This educational exhibit will review the potential areas of interface between the FDA and Interventional Radiology, including the processes for medical device approval and investigational device exemptions (IDE). Conclusion and/or Teaching Points: The research required to support the use of medical devices in Interventional JVIR ’ Posters and Exhibits S169 Radiology requires an understanding of the role of the FDA in device development, study, and regulation. This educational exhibit will provide guidance for Interventional Radiologists interested in investigating new and existing devices in order to continue the history of progress and innovation in this field. P oters nd Exibits Abstract No. 381 Enhanced antitumor efficacy of a novel vascular disrupting agent (CKD-516) for transarterial infusion therapy in hepatocelluar carcinoma (HCC) model Y. Kim, J. Chung, J. Park, S. Kim, H. Jae, C. Ahn, D. Lee, Y. So; Radiology, Seoul National University College of Medicine, Seoul, Republic of Korea; Chong Kun Dang Research Institute, CKD Pharmaceuticals, Yongin, Republic of Korea; Department of Materials Science and Engineering, College of Engineering, Seoul National University, Seoul, Republic of Korea; Deartment of Polymer Science and Engineering, Sungkyunkwan University, Suwon, Republic of Korea; Radiology, SMG-SNU Boramae Medical Center, Seoul, Republic of Korea Purpose: CKD-516, a novel tubulin polymerization inhibitor, was developed as a dual-function agent to achieve an antimitotic effect on cancer cells and a vascular disrupting effect on preexisting tumor vessels. Our study aims to evaluate the efficacy of CKD-516 as a therapeutic agent for transarterial infusion therapy in HCC model. Materials and Methods: Experiments were performed in accordance with National Institutes of Health guidelines for the care and use of laboratory animals. VX2 carcinoma was orthotopically implanted in the liver of 11 rabbits. When the tumor diameter reached 15 20mm, the animals were randomly divided into two groups according to the CKD-516 (0.42 mg/kg) administration routes used; group A (intravenous injection, n1⁄45), and group B (intraarterial injection, n1⁄46). Dynamic contrast enhanced (DCE) MRI was performed to measure the changes of kinetic parameters in tumors before CKD-516 administration for baseline, and at day 1, and 7 postadministration. Immediately after the last MR imaging, all animals were euthanized to obtain the apoptosis rates of tumors by Tunel assay. Mean values were determined for all of the parameters measured by the perfusion maps of DCE-MRI, and apoptosis rates. A two-tailed p value less than .05 was considered to indicate a significant difference by Mann-Whitney test. Results: Serial DCE-MRI showed a similar decrease in Ktrans parameters from baseline between groups at day 1 posttreatment (58.4% in group A; 50.9% in group B), but a different recovery at day 7 (106.6% in group A; 60.1% in group B) with a statistical significance (po0.05). The tumor apoptosis rates on pathological examination were higher in group B (92.7%) than group A (74.9%) suggesting better therapeutic effect of the intraarterial administration. Conclusion: The intraarterial injection of CKD-516 may have a therapeutic benefit compared with the systemic injection in the HCC model. The application of CKD-516 to conventional TACE should be done by combing with a bead or Lipiodol for further investigation. Reference 1. Kim KW, Lee JM, Jeon YS, et al. Vascular disrupting effect of CKD-516: preclinical study using DCE-MRI. Invest New Drugs