Clinical Trials

Tomosynthesis Mammographic Imaging Screening Trial (TMIST) (PI: Kuzmiak)

Purpose: To compare the proportions of participants in the Tomosynthesis (TM) and Digital Mammography (DM) study arms experiencing the occurrence of an “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 screening for breast cancer.
Procedures (methods): In this trial, women will be randomized to screening with Breast Tomosynthesis(TM) or Digital Mammography (DM). The frequency and number of screening examinations will vary with their menopausal status and whether they have breast cancer risk factors. Women eligible for annual screening will have 5 mammograms – at baseline (T0) and four annual follow-up screening examinations (T1, T2, T3, and T4). Women eligible for biennial screening will have 3 mammograms – at baseline (T0) T2 and T4. Participant accrual is expected to be complete within 36 months after the study is funded, allowing 6 months for study activation after funding commences. All participants will be followed for at least 4.5 to 8 years after study entry.

A prospective, multicenter, multi-arm, clinical case collection program to acquire breast image data and establish an image library of exams for use in future research studies, training, marketing, and advance new product development efforts. (PI: Kuzmiak)

Purpose: The primary objective of this study is to establish a library of cases for use in future SoftVue™ research studies, user training, and marketing. Secondary objectives involve determining the frequency and severity of adverse events (AEs) to further evaluate the safety of SoftVue™.
Participants: This study will collectively enroll up to 20,500 women across multiple sites. Each arm has a different subject population based on its aim.
Procedures (methods): This multi-center prospective case collection protocol is composed of four arms using the SoftVue™ (SV) automated whole breast ultrasound system. While the SoftVue™ examination procedure will be the same for all arms, the recruitment and data collection plans vary between different arms. This project design is strictly case collection; any known investigational and statistical plans for future analyses are described in the protocol appendices.

Comparison of Stationary Breast Tomosynthesis and 2-D digital mammography in patients with known breast lesions (PI: Yueh Lee, MD, PhD)

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.
Participants: Patients at UNC Hospitals undergoing biopsies for known breast lesions will be recruited for the study.
Procedures (methods): 100 female subjects undergoing a breast biopsy are to obtain a 2-view s-DBT in the CC and MLO projection.

We will perform a reader study composed of radiologists who have experience evaluating tomosynthesis images. Each reader will review the images and score the finding(s) based on a probability of malignancy, confidence of mammographic features evaluation, specifically of micro-calcifications and masses.

LCCC 1748: Academic-Industrial Partnership for Translation of Acoustic Angiography (PI: Yueh Lee, MD, PhD)

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 comparison of radiologist preference for the two imaging techniques for each of 3 lesion characteristics.
Participants: Sixty patients who are to have a clinical surgical breast biopsy based on results from pre-study standard of care (SOC) imaging will be recruited from the UNC Breast Clinic for participation in the study.
Procedures (methods): This is a one arm single center study of patients with suspicious breast lesions (BIRADS 4 or 5) from the UNC Breast Clinic that consent to undergo an acoustic angiography in conjunction with b-mode ultrasound prior to their scheduled biopsy.

Utility of PET/MR in Surgical Planning for Breast Cancer Treated with Neoadjuvant Chemotherapy (PI: David Lalush, PhD)

Purpose: To assess the utility of PET/MR in assessing response to neoadjuvant chemotherapy and surgical treatment decisions for operable breast cancers.
Participants: Adult patients with operable breast cancer that are being treated at UNC with neoadjuvant chemotherapy
Procedures (methods): Patients who are being treated with neoadjuvant chemotherapy followed by surgical resection will undergo pre-treatment and post-treatment PET/MR and the response to treatment assessed by evaluating change in size and FDG avidity. Patients will then undergo surgery. Their pathology will be reviewed for treatment effect as assessed by percent necrosis, size, and resection margins. Patient will be followed and assessed for recurrence.

ARFI (Acoustic Radiation Force Impulse), VisR (Viscoelastic Response), and DDAI (Dynamic Displacement Anisotropy Imaging) Ultrasound for Improving Discrimination of Malignant and Unresponsive Breast Cancer (PI: Caterina Gallippi, PhD)

Purpose: The purpose of this study is to evaluate in vivo the diagnostic relevance of ultrasound-derived metrics for stiffness, elasticity, viscosity, and anisotropy.
Participants: Forty women with breast lesions that have a BIRADS-4 or BIRADS-5 rating and forty women undergoing Neoadjuvant chemotherapy (NAC) for malignant breast lesions will be recruited. Subjects will be recruited from the Breast Imaging Division of UNC Hospitals.
Procedures (methods): In this exploratory clinical study, we will attempt to demonstrate that ARFI, VisR, and DDAI ultrasound reliably detect malignant breast masses (Aim #1) and distinguish masses that respond to chemotherapy from those that do not (Aim #2). The ARFI, VisR, and DDAI imaging location will be on the surface of the breast, above the suspicious or malignant mass. This unblinded open-label, exploratory study will be conducted in forty women with diagnosed BIRADS-4 or -5 masses in Aim #1 and in forty women with malignant masses undergoing Neoadjuvant chemotherapy (NAC) in Aim #2.

LCCC1853: Novel MRI sequence MR Fingerprinting in Breast MRI Feasibility Study (PI: Cherie Kuzmiak)

Purpose: 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 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 normal breast tissue.

Participants: We will recruit a totally of 30 patients scheduled for screening breast DCE MRI for high risk normal patients.

Procedures (methods): The patients will have a set of additional research scan of no more than 12 minutes scan time (MRF) within their primary screening breast MRI study. Patient will receive their standard clinical care as usual. No follow up needed for this observational study.