MammaCare scientists developed a series of tactually accurate breast models containing small, simulated breast cancers that are considered the standard for measuring examination proficiency. The challenge was to find a way to link the models to an intelligent device that could accurately translate the examiner's subjective, tactual sensations into digital code.

MammaCare^® Clinical Breast Exam (CBE) Simulator-Trainer

Breast cancer screening by physical examination is widely performed but the common practice of CBE is deficient and erratic leading to more advanced cancers than necessary. MammaCare^®  scientists with the support of the National Cancer Institute and National Science Foundation responded to this critical health care need with a new technology, palpation training platform that teaches, measures and confirms the acquisition of breast examination skills.  

MammaCare’s CBE Simulator–Trainer is a self-administered, palpation-training platform that emulates recognized quality-standard examination protocols. The Simulator’s patented tactile sensor array “observes” and builds essential CBE performance skills through a series of palpation training modules presented and controlled by a laptop computer. As pictured below in fig 1, clinician’s fingers examine a series of tactually accurate breast models as the CBE simulator program captures and monitors their performance on the computer.

The simulator-trainer interacts with clinicians, advancing their clinical sensitivity and specificity via progressively more complex breast models that are placed on its surface. A digital “clinical instructor” guides the learner through the training modules, assessing progress and providing corrective feedback. In operation, palpation of the breast models is detected by highly sensitive tactile transducers, received by digital signal processors, and interpreted by a software program that directs practice and performance.   

The simulator’s tactile transducers locate and register every palpation at 1024 levels of examination pressure in each square centimeter of breast tissue within 3mm of spatial resolution. The instructional software modules measure the sensitivity and specificity of the trainee’s performance as it shapes palpation and search skills. The trainee meets performance standards for each module before advancing to the succeeding one.

The entire repertoire of essential examination skills including breast lesion detection, tissue coverage, search pattern completeness, and performance of the required range of palpation pressures is produced and recorded by the CBE simulator/trainer. 

By quantifying human breast examination performance, we can conclude whether clinicians have, or have not, achieved required levels of breast palpation skill. Once the simulator-trainer confirms that foundation skills have been achieved, practice in vivo on patients or surrogates is vital to build further confidence and competence.

The MammaCare CBE simulator/trainer is the only known technology that quantifies and confirms acquisition of breast examination competencies acknowledged as standards for clinical breast examination performance 1

1. Does this patient have breast cancer?  The screening clinical breast examination: Should it be done?  How?  Journal of the American Medical Association, 283(13), 1270-1280. "MammaCare’s standards for teaching and practicing effective CBE emerged from an extensive series of laboratory studies measuring lump detection and breast examination skills using tactually accurate breast models embedded with small simulated lesions"  * Barton, M. B., Russell, H., Fletcher, S. W.   

 

Finding Breast Cancer: recent research:   

A significant number of women present with palpable breast cancer even with a normal mammogram within 1 year. Am J. Surg 2010 Dec; 200(6): 712-7. Haakinson DJ, Stucky CC, Dueck AC, Gray RJ, Wasif N, Apsey HA, Pockaj B. "Patients presenting with palpable masses on SBE or CBE even with a normal mammogram within 1 year tended to have more aggressive tumors... resulting in more aggressive therapy."

Palpable presentation of breast cancer persists in the era of screening mammography. J Am Coll Surg. 2010 Mar; 210(3): 314-8. Mathis KL, Hoskin TL, Boughey JC, Crownhart BS, Brandt KR, Vachon CM, Grant CS, Degnim AAC. "Patients with palpable presentation were younger than those with screen-detected cancer (mean age 57 versus 62 years...)"

Discovery of breast cancers within 1 year of a normal screening mammogram: how are they found? Ann Fam Med. 2006 Nov-Dec; 4(6): 512-8. Carney PA, Steiner E, Goodrich ME, Dietrich AJ, Kasales CJ, Weiss JE, MacKenzie, T. "Having a lump and both a personal and a family history of breast cancer was the most common reason why women initiated a health care visit."

Self-Detection Remains a Key Method of Breast Cancer Detection for U.S. Women. J Womens Health 2011 Aug; 20(8): 1135-9. Roth MY, Elmore JG, Yi-Frazier JP, Reisch LM, Oster NV, Miglioretti DL. “Most women survivors  (57%) reported a detection method other than mammographic examination.”

Measuring performance in clinical breast examination. Br J Surg. 2010 Aug;97(8):1246-52. Wishart GC, Warwick J, Pitsinis V, Duffy S, Britton, PD. "performance measures...could help to identify clinicians who have a lower sensitivity for CBE and who may therefore require feedback and further training."

Tumor Characteristics Associated With Mammographic Detection of Breast Cancer in the Ontario Breast Screening Program. J Natl Cancer Inst 2011.Jun 22;103(12):942-50. Epub 2011 May 3 Kirsh VA, Chiarelli AM, Edwards SA, O’Malley FP, Shumak RS, Yaffe MJ, Boyd, NF “…77% of these were true interval cancers, detected clinically in the 1–2 year interval between screening examinations…”

Surveillance of women at increased risk of breast cancer using mammography and clinical breast examination: Further evidence of benefit Int J Cancer. July 2012  ;131(2): 417-25. Andrew Maurice, D. Gareth Evans, Jenny Affen, Rosemary Greenhalgh, Stephen W. Duffy, Anthony Howell "We reviewed its effectiveness in terms of tumour size, lymph node status and survival in 7,475 women seen over a 22-year period in the Manchester Family History Clinic. “.... We conclude that screening by annual mammography and CBE between age 35–50 years and 18 monthly from 50 to 60 years may diagnose breast cancer in a less advanced state in terms of size and node status."

Excessive resections in breast-conserving surgery: a retrospective multicentre study. Breast J. 2011 Nov-Dec; 17(6): 602-9. Krekel N, Zonderhuis B, Muller S, Bril H, van Slooten HJ, de Lange de Klerk E, van den Tol P, Meijer S. "Of all tumors, 72% (525/726) were palpable, and 28% (201/726) were nonpalpable. The tumor stage was T1 in 492 patients (67.8%) and T2 in 234 patients (32.2%).”

Improved Clinical Breast Examination Competencies Via Intelligent Simulator Training, July 7, 2012   German Society for Senologie, Stugart Goldstein M.K.*, Mehn M.A.*, Pennypacker H.S.*, Brost B.C.** Petersen W.O.**, Nicometo A.M.**,  MammaCare* and Mayo Clinic**  "Two independent trials found that the CBE Simulator produced significant gains in clinical breast examination skills suggesting that this technology may improve the accuracy and quality of breast cancer screening."