SUSCEPTIBILITY ARTIFACTS ON T2*‐WEIGHTED MAGNETIC RESONANCE IMAGING OF THE CANINE AND FELINE SPINE

The T2*‐weighted gradient recalled echo sequence is a sensitive means to detect blood degradation products. While not a routine sequence in magnetic resonance imaging of the spine in small animals, it can provide additional valuable information in select cases. The goal of this retrospective, cross‐sectional study was to describe findings when acquiring this sequence during magnetic resonance imaging examination of the spine in small animals. The University of Tennessee's veterinary radiology database was searched for dogs and cats that underwent magnetic resonance imaging for suspect spinal disease in which a T2*‐weighted gradient recalled echo sequence was acquired and susceptibility artifact was identified. The following information was recorded: signalment, clinical signs, location and appearance of susceptibility artifact, and final diagnosis. Thirty‐nine cases were included in the study. Extradural susceptibility artifacts were observed in cases of intervertebral disc herniation with or without associated hemorrhage (n = 28), extradural hemorrhage associated with spinal trauma (n = 2), hemophilia (n = 1), and in a cystic extradural mass (n = 1). Remaining lesions displaying susceptibility artifact were intramedullary and included presumptive acute noncompressive nucleus pulposus extrusion (n = 2), hematoma (n = 1), hemangiosarcoma metastasis (n = 1), intramedullary disc extrusion (n = 1), presumptive meningomyelitis (n = 1), and a mass of undetermined etiology (n = 1). Inclusion of a T2*‐weighted gradient recalled echo sequence may be helpful in spinal magnetic resonance imaging when standard imaging sequences are ambiguous or intramedullary lesions are observed.     

Pre-operative fibrous osteodystrophy and severe,refractory, post-operative hypocalcemia following parathyroidectomy in a dog

A 13-year-old dog exhibited dramatic, radiographic osteopenia consistent with fibrous osteodystrophy secondary to primary hyperparathyroidism. Following parathyroidectomy, the dog developed severe, prolonged hypocalcemia, but was successfully treated and discharged 32 d after surgery. A variety of factors may have contributed to this dog’s hypocalcemia including hypoparathyroidism and hungry bone syndrome.     

Anatomical Variations of the Blood Vascular System in Veterinary Medicine

Traditional veterinary anatomical models describe the branches of the caudal gluteal artery as the iliolumbar, cranial gluteal, lateral caudal, satellite of the ischiatic nerve and dorsal perineal arteries. However, some classical veterinary anatomy textbooks often indicate variations the general organization of the arterial tree, without giving any pattern of origin or illustrations of the different branching. The aim of this study was to investigate the presumptive variability of the caudal gluteal artery. Two hundred and thirty‐two pelvic halves from 116 adult dogs were examined. Twelve anatomical variations were found, nine occurring in more than 5% of the dogs, and three in <5%. A ‘long‐type’ internal iliac artery, which means short caudal gluteal and internal pudendal arteries, was identified, while a ‘perineal trunk’ was observed as an interesting arterial variation. If the caudal segment alone is taken into consideration, identical vascular patterns in both hemi‐pelvises are found in 17% of the dogs. Significant statistical correlation was found for four different types of anatomic variations and gender, two types of variations and body size, one type of variation for body side and one type of variation for head shape.     

Responses to the Standard for Exchange of Nonclinical Data (SEND) in non-US countries

The Standard for the Exchange of Nonclinical Data (SEND), adopted by the US FDA, is part of a set of regulations and guidances requiring the submission of standardized electronic study data for nonclinical and clinical data submissions. SEND is the nonclinical implementation of SDTM (Study Data Tabulation Model), the standard electronic format for clinical regulatory submissions to FDA. SEND, SDTM, and the associated Controlled Terminology have been developed by CDISC (Clinical Data Interchange Standards Consortium). In order to successfully implement SEND, interdisciplinary contributions between sponsors and CROs, need a model for task allocation. This is being undertaken by the Pharmaceutical Users Software Exchange (PhUSE). Because SEND is currently the preferred submission format of the US FDA only and will become required by it starting in December 2016, only American academic societies and companies are actively involved. An exception to this is the INHAND initiative, which leads the way in standardizing terminology for toxicological pathology. On the other hand, international globalization of other clinical and nonclinical practices is not feasible because there are substantial differences between the US and non-US countries in CRO involvement in drug development. Thus, non-US countries must consider and develop approaches to SEND that meet their needs. This paper summarizes the activities of the major organizations involved in SEND development and implementation, discusses the effective use of SEND, and details a compliance scheme (research material of the Showa University School of Medicine) illustrating how pharmaceutical companies can complete a large amount of work up to an FDA application with the effective utilization of CROs and solution providers.