In this pre-pilot study, we evaluate the effectiveness of the iBreastExam (iBE) as an early detection tool among women of Pacific Islander ancestry. We also test the acceptance of the technology with an interview of the participants. With the completion of this pilot, we have gained a preliminary understanding of the strengths and limitations of this device and the acceptance of the device in the community.

Background

Late-stage breast cancer rates in the Pacific where mammography services are limited are exceedingly high: Marshall Islands (61%), Palau (94%), and Samoa (79%). Due to the limited medical resources in these areas an alternative accessible technology is needed. The iBreast Exam (iBE) is a point-of -care electronic palpitation device that has a reported sensitivity of 86%. However, little is known about the performance and acceptability of this device for women in the Pacific.

Objective/Aims

Our objective is to assess breast cancer detection among women in the Pacific, using a hand-held point-of-care medical device for breast cancer screening which could potentially augment diagnostic mammography in the Pacific Islands.

Our overall hypothesis is the utility of iBreastExam (iBE) device, combined with Clinical Breast Exam (CBE), will find invasive breast cancer lesions sooner than CBE alone and without a higher biopsy rate than screening mammography.

Our specific aims are:

  1. Characterize iBE-specific elasticity using phantoms with tissue-like elasticities to understand the detectability of malignant lesions in terms of diameter, depth, breast density and thickness
  2. Investigate the sensitivity and specificity of iBE versus mammography and recommended to undergo biopsy, as well as the test-retest precision of the iBE alone
  3. Assess the acceptability of iBE by age, race/ethnicity, mammography history, and knowledge/attitudes regarding breast cancer and screening practices among women with Chamoru, Filipino, Native Hawaiian and other Pacific Island ancestry.

Methods

A total of 39 women (ages 42–73 years) were recruited in Guam with 19 women having a mammogram requiring biopsy (Breast Imaging-Reporting and Data System [BI-RADS] category 4 or above) and 20 women with a negative screening mammogram before the study visit. Participants received an iBE exam and completed a 26-item breast health questionnaire to evaluate the iBE. Furthermore, the performance characteristics of the iBE were tested using gelatin breast phantoms in terms of tumor size, tumor depth, and overall breast stiffness.

The iBE is linked wirelessly to a smartphone and can display a visualization in real time and store data digitally.
(a) The iBE app screen is marked with high (red), medium (yellow), and low (green) stiffness regions.
(b) Diagram of the general operation of the iBE device

Results

The iBE had a sensitivity of 20% (two true positives to eight false negatives) and specificity of 92% (24 false positives to 278 true negatives) when analyzed based on the location of the tumor by quadrant. The iBE also had generally poor agreement according to a Cohen’s kappa value of 0.068. The phantom experiments showed that the iBE can detect tumors as deep as 2.5 cm, but only if the lesion is greater than 8 mm in diameter. However, the iBE did demonstrate acceptability; 67% of the women reported that they had high trust in iBE as an early detection device.

Conclusions

The iBE had generally poor sensitivity and specificity when tested in a clinical setting which does not allow its use as a screening tool.

Impact

This study demonstrates the need for an alternative screening method other than electronic palpation for lower-middle-income areas.

Published Work

Valdez D, Cruz T, Rania S, Badowski G, Cassel K, Wolfgruber T, et al. Low clinical efficacy, but good acceptability of a point-of-care electronic palpation device for breast cancer screening for a lower middle-income environment. Med Phys [Internet]. 2022 Feb 1 (CITE)

Research Team

John Shepherd, PhD

Co-Principal Investigator

UH Cancer Center

Gertraud Maskarinec, MD, PhD

Co-Investigator

UH Cancer Center

Kevin Cassel, DrPH

Co-Investigator

UH Cancer Center

Teofila Cruz, PhD, RN

Co-Principal Investigator

University of Guam

Roy Salvador Adonay, MS

Co-Investigator

COO, Administrator, Guam Radiology Consultants

Guam

University of Guam
UOG Station
Mangilao, Guam 96913

Guam Radiology Consultants
633 Gov. Carlos Camacho Rd.
Tamuning, Guam 96913
Phone: (671) 649-1001
Fax: (671) 648-1002

Hawaiʻi

University of Hawaiʻi Cancer Center
701 Ilalo Street
Honolulu, HI 96813

Funding Source(s)

National Cancer Institute
U54CA143727-09
09/01/2018 – 8/31/2020

This study is funded by the U54 Grant #5U54CA143727: University of Guam/University of Hawaii Cancer Center Partnership under Dr. Neal Palafox. Since 2003, the University of Hawaiʻi Cancer Center (UH Cancer Center) and the University of Guam (UOG) have worked in partnership to explore the reasons behind significant cancer health disparities among Pacific Islanders in Hawaiʻi, Guam and the neighboring U.S. Associated Pacific Islands (USAPI). The University of Guam/University of Hawaiʻi Cancer Center Partnership is one of only 14 Partnerships to Advance Cancer Health Equity (PACHE), a program of the NCI that supports cancer research capacity building at minority-serving institutions and collaborative research addressing cancer health disparities and their impact on underserved and socio-economically disadvantaged populations. The UOG/UH Cancer Center Partnership is the only PACHE serving Pacific Islanders (PI), with an emphasis on Micronesians. The partnership addresses cancer health disparities through research, training, and community outreach.