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UNC Radiology clinical and radiological science faculty are engaged in multiple clinical trials. Our studies investigate new approaches to diagnostic radiology and treating diseases and conditions. The clinical trials include close collaboration between scientists and physicians from many areas of expertise. All trials are overseen by the Institutional Review Board (IRB) to ensure the highest ethical standards.

RADIOLOGY SPECIALTY

Abdominal Imaging  | Breast Imaging  | Cardiac Imaging | Molecular Imaging & Therapeutics

Musculoskeletal Imaging |  Neuroradiology  | Thoracic Imaging

Abdominal Imaging

Cross-Sectional Study of Contrast-Enhanced Ultrasound with Lumason/Definity as a Screening Tool for Kidney Cancer in Patients with Von Hippel-Lindau

Purpose: To determine if contrast-enhanced ultrasound can detect abnormal features of kidney lesions in patients with Von-Hippel Lindau with the same accuracy as conventional ultrasound and contrast-enhanced magnetic resonance imaging.

PI: Emily Change, MD

Active Enrolling

For more information: ClinicalTrials.gov


Contrast-Enhanced Ultrasound for Kidney Cancer Subtyping and Staging

Purpose: To determine if contrast-enhanced ultrasound (CEUS), an experimental imaging test, can predict if a mass is malignant or benign.

PI: Emily Change, MD

Active Enrolling

For more information: ClinicalTrials.gov


Ersan Altun, M.D.

Multiparametric MRI (mpMRI) for Preoperative Staging and Treatment Planning for Newly-Diagnosed Prostate Cancer

Purpose: The purpose of this research study is to test if a new MRI imaging exam called mpMRI combined with PIRADSv2 is useful for evaluating prostate cancer in finding aggressive diseases.

PI: Ersan Altun, MD

Active Enrolling

For more information: ClinicalTrials.gov


Effect on Body Movement and Mental Skills in Patients Who Received Gadolinium-based Contrast Media for Magnetic Resonance Examination Multiple Times Within 5 Years (ODYSSEY)

Purpose: To prospectively assess the potential effect of repeated exposure to either a linear or a macrocyclic gadolinium-based contrast agent (GBCA) on change from baseline to Year 5 in motor and cognitive function among neurologically normal adults in comparison to a matched non-GBCA–exposed control group.

PI: Lauren Burke, MD

Active Enrolling

For more information: ClinicalTrials.gov


Novel MRI Sequence- MR Fingerprinting

The purpose of this study is to evaluate novel quantitative MRI techniques in clinical studies to determine whether they can provide better, faster and more useful information for clinical diagnosis. In this study, we propose to apply MR Fingerprinting at UNC and evaluate its performance for different diseases. These include but not limited to diseases in liver, kidney, cardiac, pancreas etc. We hypothesis that the quantitative MR imaging technique will lead to improved tissue characterization and diagnosis.

PI: Bryan Hyslop, MD

Completed: Data Analysis Stage

For more information: ClinicalTrials.gov


Contrast-enhanced Ultrasound for Complex Kidney Lesion Diagnosis in Patients with CKD extension (CEUS CKDx)

Purpose: The primary objective of the study is to estimate the sensitivity of CEUS in diagnosing kidney malignancy in patients with a risk factor for kidney malignancy and compare it to the current gold standard test in this patient population. Secondary analysis will include more optimal contrast-enhanced imaging with computed tomography (CT) or magnetic resonance imaging (MRI) in a subset of patients who can receive these studies. The study outcome will lead to immediate clinical application in patients with chronic kidney disease. Given the cost-effectiveness and adverse event profile, it has excellent potential to become established as first-line diagnostics in the general patient population as well.

PI: Emily Change, MD

Completed: Study Results


Contrast-enhanced Ultrasound for Complex Kidney Lesion Diagnosis (CEUS CKD)

Purpose: The primary objective of the study is to estimate the sensitivity of CEUS in diagnosing kidney malignancy in patients with a risk factor for kidney malignancy and compare it to the current gold standard test in this patient population. Secondary analysis will include more optimal contrast-enhanced imaging with computed tomography (CT) or magnetic resonance imaging (MRI) in a subset of patients who can receive these studies. The study outcome will lead to immediate clinical application in patients with chronic kidney disease. Given the cost-effectiveness and adverse event profile, it has excellent potential to become established as first-line diagnostics in the general patient population as well.

PI: Emily Change, MD

Completed: Study Results

Breast Imaging

Reproductive Axis Maturation in the Early Post- Menarchal Years: a Pilot Study

The purpose of this study is to determine the physiologic and pathophysiologic
underpinnings of irregular menstrual cycles among adolescents in the early postmenarchal
period.

PI: Cherie Kuzmiak, DO

Active Enrolling
For more information: Clinicaltrials.gov


TMIST

Purpose: To compare the proportions of participants in the Tomosynthesis (TM) and Digital Mammography (DM) study arms experiencing the occurrence of “advanced” breast cancer at any time during a period of 4.5 years from randomization, including the period of active screening and a period of clinical follow-up after the last screen (T4).
Participants: Women being screened for breast cancer.

PI: Cherie Kuzmiak, DO

Active Enrolling

For more information check out clinicaltrials.gov


Novel MRI sequence- MR Fingerprinting in Breast MRI- Feasibility study

The purpose of this study is to evaluate the novel quantitative MRI techniques, namely MR Fingerprinting (MRF), in clinical studies to establish the T1 and T2 value baselines of normal glandular tissue. The ultimate goal of this study is to evaluate the potential clinical efficacy of a novel magnetic resonance imaging (MRI) approach, MR fingerprinting, capable of providing quantitative measures of important tissue properties, which could provide important insights into the normal breast tissue.

PI: Cherie Kuzmiak, DO

Active Enrolling

For more information: ClinicalTrials.gov

Cardiac Imaging

James Gruden headshot

Post COVID-19 Hypoxemic Respiratory Failure Residual Pathophysiologic Outcomes

This is a 48-week, observational study looking to see if the inflammatory process of hypoxemic respiratory failure associated with COVID-19 leads to progressive pulmonary fibrosis.

PI: James Gruden, MD

Completed: Data Analysis Stage

For more information: ClinicalTrials.org


Molecular Imaging & Therapeutics

Jorge Oldan, MD Headshot

[18F] Fluoroestradiol (FES) PET as a Predictive Measure for Endocrine Therapy in Patients with Newly Diagnosed Metastatic Breast Cancer

This phase II trial studies F-18 16 alpha-fluoroestradiol (FES) positron emission tomography (PET)/computed tomography (CT) in predicting response to endocrine therapy in patients with newly diagnosed breast cancer that has spread to other parts of the body. FES is a radioactive form of the hormone estrogen and may “light up” where cancer is in the body. Diagnostic procedures using FES, such as FES PET/CT, may help measure the FES and help doctors predict how well the cancer will respond to treatment.

PI: Jorge Oldan, MD

Active Enrolling

For more information: ClinicalTrials.org


Jorge Oldan, MD Headshot

Evaluation of Endometriosis with 18F-fluoroestradiol PET / MRI

 The primary objective is to evaluate the sensitivity and specificity of 18F-fluorofuranylnorprogesterone (FFNP) PET/MR for evaluating endometriosis. Secondary objectives include comparing PET to conventional MRI, using histopathology from laparotomy as the gold standard and evaluating association of uptake values (SUV-max) with EHP-30 and pain rating scales, controlling for covariates.

PI: Jorge Oldan, MD

Active Enrolling

For more information: ClinicalTrials.org

Jorge Oldan, MD Headshot

18-fluorofuranylnorprogesterone (FFNP) PET/MRI as a potential biomarker of response to progesterone therapy in complex atypical hyperplasia (CAH) and grade 1 endometrial cancer (EC)

The purpose of this study is to evaluate FFNP PET/MRI’s utility for predicting response to Levonorgestrel-releasing Intrauterine Device (LR-IUD) hormonal therapy for Complex Atypical hyperplasia (CAH) and Endometrial Cancer (EC).

PI: Jorge Oldan, MD

Active Enrolling

For more information: ClinicalTrials.org

Amir Khandani headshot

The PONDER Study: Post-Operative Neurocognitive Decline: Exploring the Role of Synaptic Density

The purpose of this study is to determine the impact of surgery and anesthesia on brain structure (e.g., synaptic density, gray matter volume) and function (e.g., resting activity, cognition). The information we learn by doing this study may help us understand how surgery and anesthesia influence the brain.

PI: Amir Khandani, MD

Completed: Data Analysis Stage

For more information: ClinicalTrials.gov

Musculoskeletal Imaging

Daniel Nissman headshot

Wrist Fracture Evaluation with a Desktop Orthopedic Tomosynthesis System

Purpose: The primary objective is to compare (using a reader study) the sensitivity of Tomo-E compared to radiography of the wrist in detecting wrist fractures.

PI: Daniel Nissman, MD

Completed: Data Analysis Stage

For more information: ClinicalTrials.gov

Neuroradiology

 

High Frame Rate 3-D Super Resolution Ultrasound Microvascular Imaging

Purpose: This is a 3 arm single-center study of 35 patients scheduled to undergo a breast or thyroid biopsy that consent to undergo an acoustic angiography in conjunction with b-mode ultrasound prior to their scheduled biopsy. Prior to imaging clinical patients, the third arm will include 5 healthy volunteers that will be imaged to optimize imaging parameters. The primary objective of this study is to compare the sensitivity and specificity of super-resolution acoustic angiography with traditional b-mode ultrasound in the distinction of malignant versus benign breast and thyroid lesions. Secondary objectives include a comparison of area under the curve (AUC) for acoustic angiography versus b-mode ultrasound and a comparison of radiologist preference for the two imaging techniques for each of 3 lesion characteristics.

PI: Yeah Lee, MD, PhD

Active Enrolling

For more information: ClinicalTrials.gov


Change in Relative Cerebral Blood Volume as a Biomarker for Early Response to Bevacizumab in Patients with Recurrent Glioblastoma

Purpose: To determine whether binary changes (increase vs. decrease) in normalized rCBV within enhancing tumor from baseline to 2 weeks after initiation of anti-angiogenic therapy are associated with overall survival (OS).

PI: Yeah Lee, MD, PhD

Completed: Data Analysis Stage

For more information: ClinicalTrials.gov


Comparison of Stationary Breast Tomosynthesis and 2-D digital mammography in patients with known breast lesions

Purpose: The aim of this research is to perform a pilot clinical imaging study of patients undergoing biopsies for known breast lesions to compare the 3D s-DBT (stationary digital breast tomosynthesis) with the conventional 2-D digital mammography, the current gold standard, and to determine whether the 3-D images compared to the 2-D images will improve the Receiver Operating Characteristic curves.

PI: Yeah Lee, MD, PhD

Completed: Data Analysis Stage

For more information: ClinicalTrials.gov


Academic-Industrial Partnership for Translation of Acoustic Angiography

Purpose: the primary objective of this single arm study is to compare the sensitivity and specificity of acoustic angiography with traditional b-mode ultrasound in the distinction of malignant versus benign breast lesions. Secondary objectives include a comparison of area under the curve (AUC) for acoustic angiography versus b-mode ultrasound and a comparison of radiologist preference for the two imaging techniques for each of 3 lesion characteristics.

PI: Yeah Lee, MD, PhD

Completed: Data Analysis Stage

For more information: ClinicalTrials.gov


MR fingerprinting: A novel sequence applied to neuroimaging

The purpose of this study is to evaluate novel quantitative MRI techniques in clinical studies to determine whether they can provide better, faster and more useful information for clinical diagnosis. In this study, we propose to apply MR Fingerprinting at UNC and evaluate its performance for different neurological diseases. We hypothesis that the quantitative MR imaging technique will lead to improved tissue characterization and diagnosis.

PI: Yeah Lee, MD, PhD

Completed: Data Analysis Stage

For more information: ClinicalTrials.gov

Thoracic Imaging

Ertan Pamuklar, M.D.

Clinical Evaluation of Primary Sampling Scatter Correction for Chest Tomosynthesis

Purpose: This is a study that will evaluate the utility of a scatter reduction technique in reducing the dose and increasing the sensitivity of stationary digital chest tomosynthesis (s-DCT) in the detection of lungs. Digital tomosynthesis is an imaging modality that produces 3D sectional information using x-ray projections acquired over a limited scanning angle. Scatter is known to be the primary source of image degradation in x-ray-based imaging.

PI: Ertan Pamuklar, MD

Completed: Data Analysis Stage

For more information: ClinicaTrials.gov