Abstract P1-02-09: Clinical studies of palpation imaging of the breast on over 1000 patients

INTRODUCTION Palpation Imaging (PI) of the breast is based on the principles of tactile imaging, a method for measuring the elasticity lesions using a tactile sensor array. PI provides objective data beyond subjective manual palpation by quantifying the shape and hardness of a lesion as well as creating a permanent digital image. PI is also known as "Tactile Imaging", "Mechanical Imaging", "Stress Imaging" or "Computerized Palpation". It quantitatively evaluates mechanical and structural properties of a breast lesion that is altered by tumor growth, and provides a quantitative characterization of the detected lesion. PI is a radiation-free and an inexpensive in comparison to other imaging devices. The purpose of this paper is to evaluate the clinical efficacy of PI by summarizing all clinical studies conducted to date with this technology. METHODS The two step process to identify the clinical presence of a breast cancer include identifying the presence of an abnormality and secondarily to determine if that abnormality is malignant. Not all studies examined each portion of this two-step process. There have been 9 clinical studies involving 1,155 symptomatic patients using PI in the U.S., China, and UK. To examine the ability of PI to detect an abnormal breast mass, we reviewed the sensitivity comparisons with CBE. To determine whether a breast lesion was malignant, we reviewed the analysis of the sensitivity, specificity and accuracy for the standard imaging modalities; mammography, breast ultrasound, clinical breast examinations (CBE) and MRI using pathology as the gold standard. Calcifications were not included because they represent DCIS which does not present clinically and is the subject of over diagnosis. RESULTS All studies included in this initial meta-analysis were on symptomatic patients. To identify the presence of an abnormality, the sensitivity of PI to detect breast masses was 89% in comparison with CBE which was 83%. To identify the presence of breast cancer, • The sensitivity of PI in detecting breast cancer was 85%, in comparison to CBE (59%), mammography (76%) and ultrasound (90%). • The specificity of PI in detecting breast cancer was 79% in comparison to CBE (78%), mammography (71%) and ultrasound (79%). • The Accuracy of PI in detecting breast cancer was 82% comparison with CBE (67%), mammography (74%) and ultrasound (84%). Breast Cancer Detection Comparision Palpation ImagingCBEMammogramUltrasoundSensitivity for Cancer Detection85597690Specificity for Cancer Detection79787179Accuracy for Cancer Detection82677484 CONCLUSIONS A summary of clinical studies conducted on symptomatic patients to date suggest that PI is (a) sensitive in the detection of breast masses and b) identifies breast cancer with similar sensitivity and specificity compared with other standard imaging modalities while being cost effective. PI may fill a gap in developing countries where little breast screening infrastructure exists. Ongoing clinical research with PI is warranted to evaluate its potential in the early diagnosis and screening for breast cancer in the U.S. Citation Format: Cary S Kaufman, Jae S Son, Eli Yered, Armen Sarvazyan. Clinical studies of palpation imaging of the breast on over 1000 patients [abstract]. In: Proceedings of the Thirty-Seventh Annual CTRC-AACR San Antonio Breast Cancer Symposium: 2014 Dec 9-13; San Antonio, TX. Philadelphia (PA): AACR; Cancer Res 2015;75(9 Suppl):Abstract nr P1-02-09.