Faculty Research Initiatives - Investigator Initiated Clinical Research
Investigator initiated clinical research provides meaningful answers to medical and scientific questions within a leading academic medical institution. Principal investigators conceive, design and manage the research in their specialty field of radiology.
Investigator Initiated Clinical Research
Principal Investigator: Laura R. Carucci, M.D.
INTUSSUSCEPTION ON MDCT FOLLOWING ROUX-EN-Y GASTRIC BYPASS (RYGBP) SURGERY: INCIDENCE AND IMPLICATIONS
Principal Investigator: Laura R. Carucci, M.D.
Sub-investigator: Mary Ann Turner, M.D.
Intussusception is a complication of gastric bypass (GBP) surgery for morbid obesity that is a reported rare cause of small bowel obstruction following RYGBP and occurs most often at the distal small bowel anastomosis. With technological advances, we now more frequently identify small bowel intussusception in the general population on CT, however, often the etiology and significance are unknown. Intussusception may be an incidental, transient finding detected on abdominal CT or may be associated with additional complications including obstruction, incarceration and rarely perforation. Many RYGBP patients present with nonspecific abdominal pain and undergo radiologic evaluation with CT of the abdomen and pelvis. However, the incidence and significance of Intussusception diagnosed with CT following RYGBP has not been described in the radiologic literature.
CHARACTERIZATION OF URETHRAL DIVERTICULA USING CT
Principal Investigator: Laura R. Carucci, M.D.
Sub-investigators: Adam P. Klausner, M.D., Ann S. Fulcher, M.D., FACR
Urethral diverticula occur in up to 6% of women and frequently present with postvoid dribbling, urethral pain and dyspareunia. In patients with classic symptomatology, a diagnosis of UD may be made with voiding cystourethrography (VCUG) and/or MRI. However, many patients may present with nonspecific and persistent abdomen and pelvis to assess the entire urinary tract. Also, UD may be an incidental finding in a patient undergoing CT for a different reason. However, the diagnosis of UD with CT has not been described in the radiologic literature, therefore, UD may be an under recognized finding on CT. We believe that CT may diagnose a urethral diverticulum, and may also assess for potential complications of a UD including calculi and neoplasm.
Investigator Initiated Clinical Research
Principal Investigator: Ann S. Fulcher, M.D.
PANCREAS DIVISUM WITHOUT PANCREATITIS ON MRCP: PREVALENCE AND SIGNIFICANCE
Principal Investigator: Ann S. Fulcher, M.D., FACR
Sub-investigators: Dengbin Wang, M.D., Ph.D., (visiting professor), Jinxing Yu, M.D.
Pancreas divisum is currently believed to be a cause of chronic and/or relapsing acute pancreatitis. However, to our knowledge, there has been no published study investigating the prevalence of pancreas divisum in patients without symptoms of pancreatitis. Therefore, the purpose of this study was to determine the prevalence of pancreas divisum in the general population — patients without symptoms of pancreatitis — in order to determine whether the presence of pancreas divisum is truly associated with a higher incidence of pancreatitis.
Investigator Initiated Clinical Research
Principal Investigator: John D. Grizzard, M.D.
UTILITY OF CINE MRI, DELAYED ENHANCEMENT AND FIRST-PASS PERFUSION IN THE EVALUATION OF CARDIAC MASSES BY MAGNETIC RESONANCE IMAGING
Principal Investigator: John D. Grizzard, M.D.
Sub-investigator: Sarah Joyner, M.D. (Cardiology)
In collaboration with cardiologists and radiologists at Duke University, Drs. Grizzard and Joyner are investigating the usefulness of new MRI techniques for diagnosing cardiac masses. The challenge in evaluating a patient with a suspected cardiac mass is the accurate differentiation of the mass, because different types of masses require very different kinds of treatment, or even no treatment. Therefore, the goal of cardiac mass imaging, and of this study, is to minimize unnecessary invasive procedures to the patient and to direct appropriate medical management.
STANDARD FOR QUANTIFICATION OF DELAYED-ENHANCEMENT MAGNETIC RESONANCE IMAGING OF MYOCARDIAL INFARCTION - A MULTICENTER STUDY
Principal Investigator: John D. Grizzard, M.D.
Sub-investigator: Igor Klem, M.D. (Duke Cardiovascular Magnetic Resonance Center)
- To study the extent and source of variability in scar size measurements.
- To compare the visually determined scar size measurements to those generated with the use of computer-defined scar size using SEGMENT software.
- To study the agreement of visual assessment of scar size using a 5-point scoring system for 17 segments and quantitative measurements.
Investigator Initiated Clinical Research
Principal Investigator: Daniel Komorowski, M.D.
A HUMANITARIAN DEVICE EXEMPTION TREATMENT PROTOCOL OF THERASPHERE® FOR TREATMENT OF UNRESECTABLE HEPATOCELLULAR CARCINOMA
Principal Investigator: Daniel Komorowski, M.D.
Sub-investigators: Melvin J. Fratkin, M.D.(Ret.), Shiyu Song, M.D.,
TheraSphere® is a therapeutic device which consists of yttrium-90 as an integral constituent of insoluble glass microspheres. TheraSphere® is a non-dissolvable, non-biodegradable glass microsphere. The study has the following objectives:
- Provide supervised access to treatment with TheraSphere® to eligible patients with primary cancer to the liver who are not surgical resection candidates.
- Evaluate patient experience and toxicities associated with TheraSphere® treatment.
Investigator Initiated Clinical Research
Principal Investigator: Malcolm K. Sydnor, M.D.
RADIOFREQUENCY ABLATION VERSUS LASER ABLATION OF THE INCOMPETENT GREATER SAPHENOUS VEIN: A PROSPECTIVE RANDOMIZED TRIAL
Principal Investigator: Malcolm K. Sydnor, M.D.
Sub-investigators: Daniel A, Leung M.D., Leroy Thacker Ph.D. (Statistician)
Chronic venous insufficiency is estimated to affect 25 million Americans. This condition leads to varicose veins and their associated symptoms. The most common cause is a refluxing or incompetent Greater Saphenous Vein, which results in pooling of deoxygenated blood in the lower extremities rather than successfully transport of the blood back to the heart and lungs. A newer, less invasive, treatment option has emerged - Endovenous Thermal Ablation - in which a laser fiber or radiofrequency probe is inserted into the vein. While both types of ablation are accepted treatment options, neither technology have proven to have fewer complications or superior results.
RADIOFREQUENCY ABLATION VERSUS LASER ABLATION OF THE INCOMPETENT SMALL SAPHENOUS VEIN: A PROSPECTIVE RANDOMIZED TRIAL
Principal Investigator: Malcolm K. Sydnor, M.D.
Sub-investigators: Daniel Komorowksi, M.D., Leroy Thacker, Ph.D. (Statistician)
Chronic venous insufficiency is estimated to affect 25 million Americans. This condition leads to varicose veins and their associated symptoms. One cause is a refluxing or incompetent Small Saphenous Vein, which results in pooling of deoxygenated blood in the lower extremities rather than successfully transport of the blood back to the heart and lungs. A newer, less invasive, treatment option has emerged - Endovenous Thermal Ablation - in which a laser fiber or radiofrequency probe is inserted into the vein. While both types of ablation are accepted treatment options, neither technology have proven to have fewer complications or superior results.
A RETROSPECTIVE EVALUATION OF LONGEVITY OF FISTULAS IN DIALYSIS PATIENTS WITH CENTRAL VENOUS STENOSIS AND OCCLUSIONS AFTER ANGIOGRAPHIC INTERVENTION
Principal Investigator: Malcolm K. Sydnor, M.D.
Patients with end-stage renal disease do not have functional kidneys, leading to the need to dialyze their blood in order to filter out toxins produced daily by the body. Means of completing this include kidney transplantation or regular dialysis through catheters or arteriovenous shunts. Much work remains on developing the optimal scheme for long term central venous patency in dialysis patients with surgically created graft or fistula. The goal of this retrospective study is to determine the expected outcomes of patients with central venous stenoses or occlusions after they have undergone percutaneous treatments including angioplasty and stenting. This will give both patients and treating physicians an idea of what to expect so they can plan for the future including how long they can expect the access to function before they will likely need another intervention, consideration of a new access in a different limb, or consideration for kidney transplantation in a timely manner.
A RETROSPECTIVE, COMPARISON OF AVAILABLE SELF-EXPANDING COVERED STENTS IN DIALYSIS FISTULAS INCLUDING ACUTE OCCLUSION RATE, PRIMARY PATENCY, AND PRIMARY ASSISTED PATENCY
Principal Investigator: Malcolm K. Sydnor, M.D.
The primary accepted means for individuals with chronic renal failure to receive dialysis prior to kidney transplantation is through surgically placed upper extremity arteriovenous grafts and fistulas. Invariably, areas of stenosis develop in these grafts and their venous outflow. Traditional treatment has been venoplasty. However, when venoplasty fails, conventional treatment now includes placement of covered stents across these stenoses. Currently available, there are three types of self-expanding covered stents. We aim to review all such placements of each device over a four year period to compare the devices in terms of acute occlusion rate and long-term patency with the aim of identifying a statistically significant superior device.
A RETROSPECTIVE, COMPARISON OF OUTCOMES STUDY BETWEEN COVERED AND BARE METAL STENTS IN THE SUPERFICIAL FEMORAL ARTERY AS MEASURED BY PRIMARY PATENCY, PRIMARY ASSISTED PATENCY AND LIMB SALVAGE
Principal Investigator: Malcolm K. Sydnor, M.D.
Currently, for treatment of superficial femoral artery lesions, an interventional radiologist can use a covered or bare metal stent. However, currently only studies with sort follow up times comparing the two exists. The purpose of this study is to compare the long-term efficacy of limb salvage between covered and uncovered superficial femoral artery stents in patients with peripheral artery disease.
SPLENIC ARTERY EMBOLIZATION IN THE BLUNT TRAUMA PATIENT: SPLENIC SALVAGE RATE AND RADIATION DOSE OF PROXIMAL EMBOLIZATION WHEN COMPARED TO DISTAL EMBOLIZATION
Principal Investigator: Malcolm K. Sydnor, M.D.
Sub-investigators: Robert Halvorsen, M.D., Kumapley Lartevi (VCU School of Medicine, 2008), Daniel Leung M.D., Daniel Komorowski, M.D., Ajai Malhotra, M.D. (Trauma Surgery), Leroy Thacker, Ph.D. (Biostatistics), Jaime Tisnado, M.D.
In this medical student project supported by the Society of Interventional Radiology Foundation, researchers compared several factors — fluoroscopy time, radiation dose and outcome — in patients who underwent splenic arterial embolization for blunt abdominal trauma. Embolization of the splenic artery is a well-known and accepted treatment for blunt splenic trauma. Its primary advantages are control of hemorrhage and preservation of splenic function. Although several studies have shown that embolization of the main splenic artery is as effective as distal embolization, other studies advocate distal selective embolization with microcatheter technology. The aim of this study was to compare patient outcomes and radiation doses for proximal vs. distal splenic arterial embolization in order to provide appropriate recommendations.
Investigator Initiated Clinical Research
Principal Investigator: Jinxing Yu, M.D.
THE RELATIONSHIP BETWEEN IV FLUID INFUSION AND A SMALL AMOUNT OF ISOLATED ABDOMINAL AND PELVIC FREE FLUID IN BLUNT MALE TRAUMA PATIENTS: DETECTION WITH MDCT
Principal Investigator: Jinxing Yu, M.D.
Sub-investigators: Ann S. Fulcher, M.D., FACR, Mary Ann Turner, M.D., Charles Cockrell, M.D. (Ret.)
For many years, the male BAT patients were not expected to have any intraperitoneal fluid. If a male BAT patient did have isolated pelvic free fluid, some surgeons would do an explorative laparotomy to avoid delayed diagnosis of bowel and/or mesenteric injury. With the rapid advance of MDCT, we can now identify male BAT patients with isolated pelvic free fluid, which occurs at a frequency of about 5%. A small amount of pelvic free fluid in these patients in the absence of visualized organ injury (thereby, isolated) may be an incidental finding of little clinical significance, not requiring further treatment. This study aims to look at the potential causes of pelvic free fluid and best treatment options for these patients.
COST COMPARISON BETWEEN MRI GUIDED PROSTATE BIOPSIES AND TRUS GUIDED PROSTATE BIOPSIES IN PATIENTS WITH PERSISTENT ELEVATED PSA AND AT LEAST TWO PRIOR NEGATIVE TRUS GUIDED BIOPSIES
Principal Investigator: Jinxing Yu, M.D.
Sub-investigators: Ann S. Fulcher, M.D., FACR, Mary Ann Turner, M.D.
TRUS guided prostate biopsy in patients with persistent elevated PSA and two prior negative TRUS biopsies yield very low positive rates (5-15%). This results in subsequent repeats in TRUS biopsies, which over time generates enormous costs outweighing potential clinical benefits. Multi-parametric prostate MRI and MRI-guided biopsy have been proven to be excellent modalities to detect and localize prostate cancer, and yields a much higher positive rate in patients with at least two negative TRUS biopsies. This study is comparing the two modalities of prostate biopsy guidance to compare the positive rates and accumulated expenditures associated with each.
OBSTRUCTION OF PANCREATIC DUCT (PD) WITH NON VISUALIZATION OF A PORTION OF PD, PANCREATIC CARCINOMA OR PANCREATITIS: DIFFERENTIATION BY MRCP
Principal Investigator: Jinxing Yu, M.D.
Sub-investigators: Ann S. Fulcher, M.D., FACR, Mary Ann Turner, M.D.
To date, there has been no published study to demonstrate the usefulness of the morphologic changes in the obstructed PD to distinguish pancreatic carcinoma from pancreatitis by MRCP when a portion of PD is not visualized. We hypothesize that even with a portion of PD not visualized, there are other changes of the PD at MRCP including gradual and smooth tapering of proximal PD versus abrupt interruption with irregularity, and are more indicative of pancreatitis, despite the presence of ductal dilation or a mass. MRCP and MRI, a noninvasive imaging technique, is widely used for further evaluation in these situations. However, it is difficult to differentiate pancreatitis from pancreatic carcinoma in some instances, even with MR, particularly when a portion of PD is not visualized. Therefore, the purpose of the study is to determine if pancreatitis and pancreatic carcinoma can be differentiated on the bases of changes of the PD proximal and distal to the point of the ductal obstruction, as well as changes at the site of obstruction and in the common bile duct.
BOWEL AND MESENTERIC INJURY FOLLOWING BLUNT ABDOMINAL TRAUMA: EVALUATION WITH MDCT
Principal Investigator: Jinxing Yu, M.D.
Sub-investigators: Ann Fulcher, M.D., FACR, Robert Kennedy, IV, M.D., Ajai Malhotra, M.D. (Trauma Surgery), Mary Ann Turner, M.D.
Bowel and mesenteric injury is a surgical emergency, but it is not always obvious clinically or radiographically. In the era of multidetector computed tomography and picture archiving and communications systems, radiologists are able to detect subtle features of BMI and to determine the quantity and volume, and attenuation values of free fluid in blunt abdominal trauma patients, which are an important CT feature of bowel injury. Therefore, determining the accuracy of MDCT for the detection of bowel and mesenteric injuries in BAT patients may be important to prevent unnecessary surgery and to identify BMI that may previously have been missed. The aim of this study is to set thresholds, thereby maximizing the sensitivity and specificity of MDCT for diagnosing BMI and thus for identifying surgical patients.
MULTIDETECTOR CT DETECTION OF A SMALL AMOUNT OF ISOLATED PELVIC FREE FLUID IN MALE BLUNT TRAUMA PATIENTS: PREVALENCE AND SIGNIFICANCE
Principal Investigator: Jinxing Yu, M.D.
Sub-investigators: Ann Fulcher, M.D., FACR, Jonathan Ha, M.D., Robert Halvorsen, M.D., Ajai Malhotra, M.D. (Trauma Surgery), Mary Ann Turner, M.D.
The presence of large amounts of abdominal or pelvic free fluid on CT scan, even without evidence of organ injury, may require surgical intervention. However, management is less obvious when only small amounts of isolated pelvic free fluid are present, particularly in male blunt abdominal trauma patients, who, unlike their female counterparts, are not expected to have any intraperitoneal fluid. It is possible that in males, a small amount of pelvic free fluid in the absence of visualized organ injury may have little clinical significance and not require further intervention. The development of MDCT technology and the emergence of digital image archive systems have facilitated the means to precisely assess the volume and attenuation of free fluid. Therefore, the goal of the study is to determine thresholds for quantity and attenuation values of isolated pelvic free fluid in male BAT patients to guide management decisions.
PANCREATITIS ASSOCIATED WITH PANCREAS DIVISUM: IMAGING FEATURES ON MRI AND MRCP
Principal Investigator: Jinxing Yu, M.D.
Sub-investigators: Ann Fulcher, M.D., FACR, Mary Ann Turner, M.D., Dengbin Wang, M.D., Ph.D. (visiting professor)
The clinical significance of pancreas divisum remains controversial. Although the majority of patients with pancreas divisum have no clinical symptoms, there is a subset of patients who have either unexplained abdominal pain or relapsing acute pancreatitis. These patients may benefit from interventional management. Imaging exams play an important role in the diagnosis of pancreatitis and pancreas divisum. However, there is no published data on the imaging findings of pancreatitis associated with pancreas divisum except those on ERCP and MRCP. The purpose of this study is to establish the imaging features of pancreatitis associated with pancreas divisum and to identify the imaging characteristics of patients who may benefit from intervention.