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UNC School of Medicine

Research

Clinical Trials

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

Ersan Alton headshot. Male with short dark hair and eyes wearing glasses looking at the camera. He is wearing a blue shirt, red tie, and black suit jacket.

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 – Closed to Enrollment
For more information: ClinicalTrials.gov

Breast Imaging

Cherie Kuzmiak headshot. A female with a pixie cut and brown eyes smiling at the camera. She is wearing a light pink shirt.

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

Cherie Kuzmiak headshot. A female with a pixie cut and brown eyes smiling at the camera. She is wearing a light pink shirt.

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 – Closed to Enrollment
For more information check out clinicaltrials.gov

Interventional Radiology

Nikki Keefe's headshot. Female with long, honey blonde hair and green eyes smiling at the camera. She is wearing a white doctor's coat, and black blouse underneath. She is standing in front of a glass building with greenery in front it it.

Local Radiofrequency Ablation plus External Beam Radiation for the Treatment of Painful Thoracic and Lumbar Spine Tumors

Purpose: To determine if the combination of kyphoplasty with Osteocool ablation plus radiation therapy results in improved patient pain management for the treatment of thoracic and lumbar spine tumors.
PI: Nicole Keefe, MD
Active Enrolling

Nima Kokabi's headshot. A male with dark brown hair and eyes smiling at the camera. He is wearing a white shirt, bright yellow tie, and dark blue suit jacket.

Observational basket trial to collect tissue to develop and train a live tumor diagnostic platform (ELEPHAS-02)

The primary objective of this study is to train and validate the ELEPHAS live tumor diagnostic platform and determine the ex-vivo accuracy of the Cybrid Score using in-vivo RECIST 1.1 as the reference method.
Participants: We will enroll up to 416 subjects across all study sites. Subjects suspected of or diagnosed with Stage IV/metastatic and undergoing biopsy for the following:(1) Lung: Non-small cell lung cancer (NSCLC), (2) Head and Neck: Squamous Cell Carcinoma, (HNSCC), excluding nasopharyngeal and salivary gland cancers, (3) Kidney: Clear Cell Renal Cell Carcinoma (ccRCC), (4) Bladder: Urothelial Carcinoma (UC), (5) Skin: Cutaneous Melanoma, excluding Uveal Melanoma, (6)Uterus: endometrial cancer, (7) Colon and Rectum: Microsatellite instability-high (MSIH)/ deficient mismatch repair (dMMR) Colorectal Cancer (CRC) (8)Liver: Hepatocellular Carcinoma.
PI: Nima Kokabi, MD, FRCPC
Active Enrolling
For more information: ClinicalTrials.org

Nima Kokabi's headshot. A male with dark brown hair and eyes smiling at the camera. He is wearing a white shirt, bright yellow tie, and dark blue suit jacket.

A Prospective, Post-Approval, Open-Label, Multi-Center United States (US) Registry to Evaluate the Effectiveness and Safety of Obsidio in Clinical Practice (OCCLUDE)

Purpose: To assess effectiveness and safety outcomes of patients who undergo embolization with Obsidio™ Conformable Embolic.
PI: Nima Kokabi, MD, FRCPC
Active – Closed to Enrollment
For more information: ClinicalTrials.org

Nima Kokabi's headshot. A male with dark brown hair and eyes smiling at the camera. He is wearing a white shirt, bright yellow tie, and dark blue suit jacket.

Evaluation of a Simple-Prep Controlled Embolic (GPX Trial)

Purpose: To evaluate the safety and effectiveness of the GPX® Embolic Device when used as indicated for embolization requiring distal vessel penetration.
PI: Nima Kokabi, MD, FRCPC
Active – Closed to Enrollment
For more information: ClinicalTrials.org

David Mauro headshot. Male with brown hair and eyes is smiling at the camera. He is wearing a white shirt, a black checkered tie, and a white doctor's coat.

A prospective, multicenter, open-label single arm study evaluating the safety and efficacy of selective internal radiation therapy (SIRT) using SIR-Spheres® Y-90 resin microspheres on duration of response (DoR) and objective response rate (ORR) in hepatocellular carcinoma (HCC) patients (DOORwaY90 Study)

Purpose: To evaluate the safety and effectiveness of SIRT using SIR-Spheres Y-90 resin microspheres as first-line treatment for local control of HCC in patients with Barcelona Clinic Liver Cancer (BCLC) stage A, B1, B2, and C.
PI: David Mauro, MD
Active – Closed to Enrollment
For more information: ClinicalTrials.org

David Mauro headshot. Male with brown hair and eyes is smiling at the camera. He is wearing a white shirt, a black checkered tie, and a white doctor's coat.

Efficacy & Safety of LOBOTM Vascular Occlusion Device for Embolization of Pulmonary Arteriovenous Malformations (PAVM)

Purpose:To evaluate both the technical success and efficacy of PAVM embolization using the LOBO™ device.
PI: David Mauro, MD
Active Enrolling
For more information: ClinicalTrials.org

Gloria Salazar's headshot. A female with brown hair and eyes is smiling at the camera. She is wearing a white blouse and light blue and white jacket.

Randomized Controlled, Single-blind, Parallel-Group Trial of Ovarian Vein and Pelvic Vein Embolization in Women with Chronic Pelvic Pain and Pelvic Varices (EMBOLIZE Trial)

Purpose: To assess whether bilateral ovarian vein embolization (OVE) and pelvic vein embolization (PVE) reduces pain symptoms and improves quality of life in women with pelvic venous disease (PeVD) and chronic pelvic pain (CPP).
PI: Gloria Salazar, MD
Active Enrolling
For more information: ClinicalTrials.org

Hyeon Yu's headshot. An Asian male with black hair and brown eyes wearing glasses is looking at the camera. He is wearing a light blue shirt, dark blue tie, and grey suit jacket.

Streamlined Resin Y90 Radiation Segmentectomy for Small HCC: One & Done Trial

Purpose: To evaluate the safety and efficacy of streamlining Yttrium-90 radioembolization workflow for patients with small Hepatocellular Carcinoma (HCC) ( < 5 cm) that have no aggressive features on baseline imaging.
PI: Hyeon yu, MD
Active – Closed to Enrollment
For more information: ClinicalTrials.org

Molecular Imaging & Therapeutics

Jorge Oldan's headshot. Male with brown thinning hair and brown eyes wearing glasses. He is wearing a blue open-collar button-down shirt.

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's headshot. Male with brown thinning hair and brown eyes wearing glasses. He is wearing a blue open-collar button-down shirt.

A Phase II Trial to Evaluate Functional Imaging in Prediction of Response to Abemaciclib for Advanced Hormone Receptor-Positive, HER2-Negative Breast Cancer

Purpose: to assess the accuracy of FFNP-PET in predicting response to abemaciclib + endocrine therapy.
PI: Jorge Oldan, MD
Active Enrolling
For more information: ClinicalTrials.org

Jorge Oldan's headshot. Male with brown thinning hair and brown eyes wearing glasses. He is wearing a blue open-collar button-down shirt.

Portable Gamma Camera for Evaluation of Therapeutic Radiopharmaceutical Extravasation

Purpose: to use a portable gamma camera to determine the extravasation rates in patients receiving Radiopharmaceutical therapy.
PI: Jorge Oldan, MD
Active Enrolling

Jorge Oldan's headshot. Male with brown thinning hair and brown eyes wearing glasses. He is wearing a blue open-collar button-down shirt.

P01 Endometriosis Diagnostic and Therapeutic Collaborative Center- Project 1: Diagnosis and Treatment of Endometriosis: A Translational Approach

Purpose:To determine mechanisms preventing inflammation resolution in women with endometriosis.
PI: Jorge Oldan, MD
Active – Closed to Enrollment

Jorge Oldan's headshot. Male with brown thinning hair and brown eyes wearing glasses. He is wearing a blue open-collar button-down shirt.

EA1211: Interim FDG-PET/CT for PreDIcting Response of HER2+ Breast Cancer to Neoadjuvant Therapy: DIRECT trial

Purpose: To investigate the performance of FDG-PET/CT as a predictor of pathologic complete respone (pCR) in patients treated with neoadjuvant HER2-directed therapy.
PI: Jorge Oldan, MD
Active – Closed to Enrollment

For more information: ClinicalTrials.org

Neuroradiology

Yueh Lee, MD, PhD, headshot. An Asian male with short black hair and brown eyes, wearing glasses, is looking at the camera. He is wearing a white shirt, a pink tie, and a grey suit jacket.

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 – Closed to Enrollment
For more information: ClinicalTrials.gov

Yueh Lee, MD, PhD, headshot. An Asian male with short black hair and brown eyes, wearing glasses, is looking at the camera. He is wearing a white shirt, a pink tie, and a grey suit jacket.

Academic-Industrial Partnership for Translation of Acoustic Angiography: Contrast Enhanced Super Resolution (CESR) Imaging

Purpose:To evaluate the sensitivity and specificity of Contrast Enhanced Super-Resolution (CESR) imaging in the analysis of known breast, liver, and kidney lesions by comparing image analyses to the pathological results for these lesions.
PI: Yeah Lee, MD, PhD
Active – Enrolling
For more information: ClinicalTrials.gov

Yueh Lee, MD, PhD, headshot. An Asian male with short black hair and brown eyes, wearing glasses, is looking at the camera. He is wearing a white shirt, a pink tie, and a grey suit jacket.

EAF223: Phase II Glioblastoma Accelerated Biomarkers Learning Environment Trial (GABLE)

Purpose:For each biomarker (Dynamic Susceptibility Contrast-Enhanced MR Imaging, 18F-fluciclovine PET, MR Spectroscopy), to evaluate whether the biomarker can stratify patients with newly diagnosed glioblastoma (GBM) that have progressive enhancement within 12 weeks post-XRT into risk groups based on overall survival.
PI: Yeah Lee, MD, PhD
Active – Enrolling
For more information: ClinicalTrials.gov

Pediatrics

Will Pryor's headshot. A male with light brown hair, a beard, and blue eyes is smiling at the camera. He is wearing a blue and white checkered shirt with a pink bow tie and a white doctor's coat.

Accuracy of ultrasound for the evaluation of percutaneous gastrostomy tube position and leakage

Evaluate the accuracy of ultrasound for the evaluation of percutaneous gastrostomy tube positioning following replacement in comparison with fluoroscopic evaluation.
PI: William Pryor, MD
Active Enrolling
For more information: ClinicalTrials.gov