Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Symptoms and General Pathology

Breast Neoplasms

Body Weight

Breast Diseases

Skin Diseases

High Risk Breast Cancer Patients (all subjects)

An addition 90 seconds of DWI will be added to a clinical breast MRI for all patients agreeing to participate in the study.

Diffusion-weighted MR imaging

Cherie Kuzmiak, DO

Purpose: The purpose of this pilot study is to evaluate whether MRI of the breasts with diffusion-weighted MR imaging can identify features more specific for breast cancer in women at high-risk of developing breast cancer.

Participants: One hundred asymptomatic women at high-risk for breast cancer recommended for a clinical breast MRI identified through the UNC Breast Clinic will be consecutively recruited for this study.

Procedures (methods): Each patient will undergo a clinical breast MRI and the addition of a single 90 second diffusion weighted sequence. A reader study will be conducted at UNC after the completion of patient accrual. The images will be analysed for lesions, enhancement patterns, diffusion weighted imaging data and correlated with any pathology or 1 year follow-up MRI exam. The study information will be entered into a secure database and analyzed.

Enrollment and Recruitment:

A total of 100 high-risk women will be enrolled in this pilot study. High-risk for this study is defined as women at significantly increased risk of breast cancer. The Investigators will use the American Cancer Society Guidelines for Breast Screening with MRI as adjunct to mammography \[2\]. These guidelines recommend annual screening mammography for high risk women including BRCA mutations, first-degree relative of BRCA carrier, lifetime risk 20-25% or greater, previous history of chest radiation age 10 to 30 years and other syndromes related to increased breast cancer risk. We also included women with a history of previous high risk breast lesion(s) such as atypical hyperplasia, lobular carcinoma in situ or atypical lobular hyperplasia and a personal history of breast cancer by clinical consensus.

Patients who have been scheduled for the study will be contacted by research staff by phone to ask if they would be interested in participating in a research study. A script will be used to determine if patient is interested in hearing about a research study, if not the call will be discontinued immediately. If yes, more details will be provided to the patient to make a determination if they would like to participate.

If the patient is interested, she will be asked to come into the UNC MRI Department one hour prior to her scheduled MRI appointment. On the day of her MRI study, the patient will meet with the study coordinator or other assigned listed study personnel and will consent the subject to this study. Research coordinator/listed study personal will go through the consent form with the patient and answer any questions she may have. If patient agrees to participate after review of consent form, the patient will sign and date, the coordinator will then sign and date and patient will be formally enrolled. The patient will then undergo her ordered clinical breast MRI followed by one diffusion weighted MRI sequence.

Imaging Procedure: Each eligible patient, who provides consent for the study, will undergo a MR imaging screening questionnaire. If the patient has no contraindications, an intravenous line will be placed into a vein in the patient's arm and the patient will be placed prone with her breasts in a dedicated MRI breast coil. The patient will be given earplugs to decrease the noise level while in the magnet during the 45 minute total time period. High-resolution MRI sequences of the breasts and axillary regions will be performed before and after a gadolinium-DTPA bolus injection as per ordered clinical breast MRI protocol. Afterwards, one diffusion-weighted (DW) MRI sequence of the breast(s) will be performed. The DW sequence takes approximately 90 seconds.

The clinical images will be interpreted as per clinical protocol. The clinical radiologists will not have DW images to interpret. Therefore, it will not influence clinical decision concerning therapy.

Needle Core Biopsy/Surgery: All patients who are recommended for a needle core biopsy or open surgical biopsy for a breast lesion from their clinical Breast MRI will be scheduled by their surgeon. The radiologist performing the MRI-guided needle core biopsy or the surgeon performing the open surgical biopsy will be blinded to the results of the DW imaging, and therefore it will not influence clinical decision concerning therapy.

Reader Study: Five readers, radiologists that are experts in breast imaging and who are blinded to the study results, will be given de-identified MRI and DWI MRI images from the patient's entry MRI (MRIe) study and 1-year follow-up MRI (MRIf) study. Study radiologist data sheets will be completed for each study. The reader will have to complete the data sheets for MRIe before he/she can read and evaluate MRIf. The readers are blinded to the pathologic data at all times. For each condition MRIe and MRIf, each reader will check one of the checkboxes of each query that presents the lesion type (mass or non-mass enhancement), anatomic location (upper outer, upper inner, lower outer, lower inner or subareolar), largest dimension in centimeter, signal intensity on T1- and T2-weighted images (high, iso- or low to the fibroglandular tissue), morphology such as shape (round, oval, lobulated or irregular) and margin(smooth, irregular or spiculated) for mass, distribution (focal, linear, ductal, segmental or regional) for non-mass enhancement, enhancement pattern (homogeneous, heterogeneous, rim enhancement, dark internal septations, enhancing internal septations or central enhancement for mass; homogeneous, heterogeneous, stippled/punctate, clumped or reticular/dendritic for non-mass enhancement) and kinetic curve patterns on contrast-enhanced MRI (persistent, plateau or washout), signal intensity on DWI MRI /ADC map (high, iso-, low to the fibroglandular tissue) and an ADC value marked through quantitative analysis on the DWI study. The readers will assign any lesion(s) as benign, probably benign, suspicious and highly suggestive of malignancy according to the imaging findings and decide the probability of malignancy in percentages on contrast-enhanced MRI and DWI MRI, independently for the entry and final MRI study. After each radiologist reader has completed the data sheets for each patient, the data will be entered into a secure data base for statistical analysis.

Diffusion Weighted MR Imaging of the Breasts in Women at High Risk of Breast Cancer: A Pilot Study

Lesions will be identified by 5 trained radiologists in a reader study. The identification of lesions will be confirmed by pathologists, or if no biopsy is performed, then truth will be determined after a 1-year follow-up MRI/MRI DWI.

Trained radiologists will complete a series of questionnaires about identified lesions. Using these questionnaires, a mixed-effect ANOVA model (Obuchowski and Rockette, 1995) is to fit these summary measures of diagnostics accuracy. To test the primary hypothesis , an approximately t-distributed statistic based on Obuchowski and Rockette (1995) will be used and we reject the hypothesis if the statistic is larger than 95% percentile of a central student's t-distribution with one degree of freedom.

University of North Carolina, Chapel Hill

Patients will undergo Single Port robotic Nipple Sparing Mastectomy (SPrNSM) with immediate breast reconstruction with tissue expanders/implants and acellular dermal matrix (Alloderm)

This is a software-controlled, electro- mechanical system designed for surgeons to perform single port minimally invasive surgery.

da Vinci SP Surgical System

Deborah Farr, MD, FACS

Deborah E Farr, MD

This is a single arm, single-center, prospective clinical trial designed to track the peri, post-operative and oncologic outcomes when utilizing the da-Vinci single port (SP) robotic platform to perform robotic nipple sparing mastectomy (rNSM) and immediate breast reconstruction with tissue expanders/implants and acellular dermal matrix (ADM - Alloderm), for patients with breast cancer as well as those with a high risk for breast cancer.

Safety and feasibility measures will be measured as primary outcome measures. Oncological and patient satisfaction outcome measures will be measured. Our hypothesis is that SPr-NSM is equal to open NSM in terms of safety, feasibility and oncological outcomes with improved patient satisfaction as measured by nipple sensation and patient reported outcomes.

rNSM using the multi-port robotic platform followed by standard of care open breast reconstruction has been done successfully at multiple institutions worldwide with comparable, if not superior outcomes to an open surgical approach. This study explores this procedure with the Da Vinci SP robot with pre-pectoral reconstruction with acellular dermal matrix. The patients will be evaluated per standard of care post-operative visits at 2 weeks, 1 month, and every 6 months for five years post operatively for subjective patient satisfaction and objectively for post-operative nipple sensation. The patients will be monitored longitudinally for oncologic outcomes including the presence of a new breast cancer and/or breast cancer recurrence. Patients will be monitored for any complications related to rNSM and the use of ADM in expander and implant-based breast reconstruction.

Investigational Device:

The da Vinci SP Surgical System, Model SP1098 is a software-controlled, electro- mechanical system designed for surgeons to perform single port minimally invasive surgery. The Model SP1098 Surgical System consists of a Surgeon Console, a Patient Cart, and a Vision Cart, and is used with a Camera Instrument, EndoWrist SP Instruments, and Accessories.

Indications for Use:

The da Vinci SP Surgical System, Model SP1098 is cleared for use in urologic surgical procedures that are appropriate for a single-port approach and transoral otolaryngology procedures restricted to T1 and T2 tumors. This investigational study will evaluate device usage in nipple sparing mastectomy (NSM) procedures.

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Safety and Feasibility of Robotic Single-port (SP) Nipple Sparing Mastectomy: A Single Institution, Single Arm Pilot Trial

The number of participants who complete single port nipple sparing mastectomy (SPrNSM) will be measured.

Perioperative complications will be described using the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTACAE) v. 4.03 criteria. Complications will refer to any medical occurrence directly attributed to the surgical procedure during and within the first 30 days following use of the SP robotic platform and ADM. Grade 3, 4, or 5 complication or adverse event will constitute an event. Perioperative complication rates will be compared to historical complication rates.

The pathologist will assess margin status in patients undergoing SPrNSM

The PI will assess recurrent breast cancers.

Patient satisfaction is measured by BREAST-Q reconstruction tool at baseline, postoperatively at 2 weeks, and every 6 months for 5 years. BREAST-Q reconstruction module and Breast implant illness survey for patients. Questions about self-confidence, comfort, acceptance of new appearance, feeling of implants, breast pain. The score represents questionnaires about different domains and each question has four possible dimensions. The values of these dimensions varies from 1 (minimum score- worst outcome) to 4 or 5 (maximum score- best outcome) (Likert Scale) depending on part of the questionnaire .

Patient satisfaction is measured by BREAST-Q sensation tool at baseline, postoperatively at 2 weeks, and every 6 months for 5 years and it is another tool to help quantify breast sensation both pre-operatively and post-operatively. The Breast-Q is comprised of 2 domains - i) Satisfaction domains and ii) Well-being domains, which are further divided into sub-domains. We will be using 3 satisfaction sub-domains: i) Satisfaction with breasts ii) Satisfaction with Nipple iii) Satisfaction with outcome and 3 well-being sub-domains: i) Psychosocial well-being ii) Sexual well-being and iii) Physical well-being. The values range from 1 (minimum score- worst outcome) to 4 or 5 (maximum score- best outcome) (Likert Scale) depending on part of the questionnaire.

Degree to which the patients maintain nipple sensation will be measured by Semmes Weinstein monofilament tool at baseline, postoperatively at 2 weeks, and every 6 months for 5 years. Monofilament diameter and force will be measured at 9 different locations of the breast to determine the degree of sensation.

Reconstruction outcomes is measured by short term complications (wounds, infections, seromas, and device exchange or loss) that occur post-operatively after surgery Short term complications will be described using the NCI CTACAE v. 4.03 criteria.

Long term complications will be described using the NCI CTACAE v. 4.03 criteria and will refer to any medical occurrence directly attributed to the surgical procedure up to 5 years following use of the SP robotic platform and ADM. Grade 3, 4, or 5 complication or adverse event will constitute an event.

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Diffusion Weighted MR Imaging of the Breasts in Women at High Risk of Breast Cancer: A Pilot Study	NCT01938157	Breast Cancer	Diffusion-weigh...	21 Years -	University of North Carolina, Chapel Hill
Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy	NCT05245812	Breast Cancer High Risk of Br...	da Vinci SP Sur...	18 Years - 80 Years	University of Texas Southwestern Medical Center

Spots Global Cancer Trial Database for high risk of breast cancer