Protocol: Evaluation Of Breast Masses Using Vibrational Doppler Imaging

Investigator: Brian S. Garra, MD & Robert Oppenheimer, MD

Summary Goals of project:

• To develop and evaluate vibrational doppler (VDI) as a novel sonographic technique for visualizing tissue elasticity.
• To determine the use of doppler ultrasound of tissue vibration as an aid to breast mass detection and diagnosis.
• To determine the optimal vibration frequency or pitch.
• Determine whether breast lumps can be classified as cancer or benign using VDI.

Protocol: A Prospective, Randomized Comparison Of The Use Of Iodinated Contrast Media or Carbon Dioxide During Renal Artery Stent Dilation.

Sponsor: Nycomed, AVE (pending)

Investigator: Christopher S. Morris, MD

Summary Goals of project:

• To compare angiographic and clinical outcomes (safety & efficacy) of renal artery stent dilation using iodinated contrast media to CO2 in patients with renal vascular disease and renal insufficiency.

Protocol: Combining Clinical, Sonographic, and Elastographic Feature To Improve The Detection Of Prostate Cancer.

Investigator: Brian S. Garra, MD

Summary Goals of project:

• To adapt new methods of ultrasound signal processing to the detection of prostate cancer.
• To determine which combination of the new methods of signal processing works best for detection of prostate cancer.
• To refine the methods above to produce a high-resolution image that may be used to guide a physician to the areas of the prostate gland most likely to contain cancer.

Protocol: Evaluation Of Clinical Applications of Elastography

Sponsor: NIH

Investigator: Brian S. Garra, MD

Summary Goals of project:

• To establish, define, and determine if elastography is capable of differentiating normal and abnormal tissues, including cancer, in an in vivo clinical environment in the breast and other superficial organs.

Protocol: Use of Backscattered Ultrasound To Assess Bone Density At Multiple Sites At Risk For Pathologic Fracture.

Sponsor: GE, FDA

Investigator: Brian S. Garra, MD

Summary Goals of project:

• To demonstrate that ultrasound backscatter may be used to accurately estimate bone mineral density in the hip and spine.

Protocol: ITI Renal Stent for the Treatment of Renovascular Hypertension

Sponsor: IntraTherapeutics, Inc

Investigator: Kenneth Najarian, MD

Summary Goals of Project:

• The purpose of the study is to demonstrate the ITI Renal Stent is safe and effective for the treatment of significant renovascular hypertension caused by renal artery stenosis or occlusion

Protocol:Comparison of B flow Sonography with Magnetic resonance Angiography, Contrast Arteriography, and Doppler Ultrasound for Carotid Stenosis Grading

Sponsor: General Electric

Investigator: Brian Garra, MD & Gary Alsofrom, MD

Summary Goals of Project:

• The aim of the study is to demonstrate B-flow/B-mode ultrasound estimates of carotid stenosis will be significantly more accurate and precise than doppler US estimates and will closely correlate with the gold standard test- carotid arteriography. Also, the estimates made using B-Flow/B-mode will correlate closely with magnetic resonance angiography.

Protocol: Ultrasound Localization of Neonatal Umbilical Catheter with Plain Radiography and Ultrasound: A Comparison

Investigator: Janice Gallant , MD

Summary: Objectives of the study include:

• Compare the reliability of assessing vascular catheter positioning using plain film vs. ultrasound. Evaluate and determine an appropriate approach to umbilical artery cathertization using ultrasound. Compare cost analysis, length of procedure time, and technical feasibility between the two scans

Pending Protocols

Quantitative Lymphoscintigraphy for Patients with Primary or Secondary Lymphedema.

Investigators: Brian Garra, MD & Patricia O’Brien, MD

3-D Breast imaging, determining accuracy for breast lesions

Investigators: Betty Sussman, MD, Kevin Kelly, MD & Brian Garra, MD

Optic Nerve Flow in Glaucoma Patients

Investigators: Brian Garra, MD

Low-dose doxycycline treatment of knee osteoarthritis

Investigators: Sheldon Cooper, MD, Bonita Libman, MD & Charles Pappas, MD

Radiology Component Protocols:

Subclinical Thrombosis associated with Peripherally Inserted Central Catheters (PICC)

Investigators: Katharine Habeeb, MD & T. Glen Bouder, MD

This study uses doppler ultrasound to determine if a patient with a PICC line has a developing blood clot in the arm with the IV.

A Phase II, Randomized, Double-Blind, Placebo Controlled Study to Evaluate the Preliminary Efficacy, Pharmokinetics, and Immunogenicity of BMS-188667 Administered to Subjects with Relapsing-Remitting Multiple Sclerosis

Sponsor: Bristol-Meyer Squibb

Investigators: Hillel Panitch, MD and Steve Braff, MD

Study aims to demonstrate the preliminary efficacy of BMS-188667 in subjects with relapsing-remitting multiple sclerosis, by showing a reduction in the cumulative number of new gadolinium-enhancing lesions that appear on T1-weighted MRI over Day 85 through Day 225 as compared to placebo. This study requires approximately 10 MRIs per patient enrolled.

Stable Isotopes Probes for Assessment of Gastric Emptying Times

Investigator: Naomi Fukagawa, MD PhD

The protocol objective is to test a consistent meal preparation containing a stable, nonradioactive compound that will be suitable for use in a practioners office assessing an individual’s gastric emptying time.

Bayer Study

Investigator: Hillel Panitch, MD

More information on this study to come.

Correlation of Sibling Pairs in ADHD Families

Investigator: James Hudziak, MD; Robert Althoff, MD

MRI of the head will be used to evaluate regional brain volume differences in sibling pairs with a history of ADHD to determine whether differences in volume and shape correspond with one or more different conceptions of ADHD.

Prognostic Significance of endorectal MRI in Predicting Outcome after Combined Radiation and Androgen suppression for Prostate Cancer: A Prospective Phase II Study

Investigators: Peter Swift, MD & George Philips, MD

The objective of this study is establish if the changes noted on an endorectal coil MRI study, performed at baseline and then after two months of total androgen suppression, predict for biochemical control after radiation therapy for prostate cancer. Images will be reviewed at a core lab as well as through our department for greater quality assurance.

Reduction in Obesity and Coronary Risk Factors after High Caloric Exercise Training in Overweight Coronary Patients

Investigators: Philip Ades, MD; Patrick Savage, MS

MRI of the Pelvis to Evaluate Uterine Fibroids

Investigator: Gailyn Thomas, MD

Use of MR to verify the diagnosis of uterine fibroids and obtain baseline measurements. Follow-up MR exams at 6 and 12 month timepoints will be perfomed to assess regrowth of uterine fibroids and provide assessment for clinical action.

NM Whole body Bone Scan in NSCLC

Sponsor: Glaxo-Smith Klein

Investigator: Steven Grunberg, MD

Use of nuclear imaging to evaluate patients with clinical evidence of bony metasases with a whole body bone scan. A bone scan will be performed at baseline for the patient's with clinical evidence at baseline and will be repeated every 6 weeks to follow the bony lesions for disease assessment.