A New Way to Detect Breast Cancer

In In The News by Barbara Jacoby

By: Sophie Cousins

From: nytimes.com

Not long before Mihir Shah was to be married in 2007, his soon-to-be mother-in-law got a diagnosis of breast cancer. She underwent chemotherapy and survived, wearing a wig to the wedding.

But while the women in Mr. Shah’s family — in both India and the United States — were able to get breast cancer screening, it made him think of the millions who weren’t as fortunate.

More than 90 percent of women in the developing world don’t have access to early detection of breast cancer. One reason is that mammograms, the gold-standard screening technique, are rarely used because of their high cost and a lack of trained radiologists. India has one radiologist for every 100,000 people; the United States has 12.

Then there are logistical challenges like a lack of electricity and poor roads. Many people are not aware of cancer, and the disease still carries a stigma.

As a result, patients turn up for treatment at advanced stages of the disease. Too often, a quick death is inevitable.

In the United States, 90 percent of women with breast cancer survive five years. In India 66 percent do; in Uganda only 46 percent do. Every year more than 70,000 Indian women die of breast cancer, more than anywhere else in the world.

Such poor survival statistics propelled Mr. Shah, a computer engineer, to ask: Is it possible to offer women breast cancer screening that doesn’t rely on mammograms?

He knew that whatever device he designed would have to be usable by community health care workers, the backbone of most developing countries’ health systems. It would also have to be portable and battery operated. And screening would have to affordable and painless.

Using a new ceramic sensor technology developed at Drexel University’s School of Biomedical Engineering, Science and Health Systems in Philadelphia to detect subtle variations in breast tissue, Mr. Shah and his colleague Matthew Campisi developed iBreastExam, a battery-operated wireless machine that records variations in breast elasticity. It’s hand-held and allows health care workers to perform breast examinations in five minutes, anywhere. Painless and radiation-free, it provides results just a few minutes after the exam through a mobile app, which also records patients’ data.

In 2015, Mr. Shah asked Dr. Brian Englander, an associate professor of clinical radiology at the Perelman School of Medicine at the University of Pennsylvania, to lead an evaluation of iBreastExam. Dr. Englander first assumed the technology would fail.

“Mammography is the standard of care,” he said. “Anything that deviates from it, we’re skeptical.”

But his doubts didn’t last long. The study, published in the World Journal of Surgical Oncology, concluded that the device demonstrated excellent sensitivity, meaning it was able to correctly detect clinically significant lesions in patients.

“I hope something like the iBreastExam would be accepted in the United States because there’s places and groups that don’t have access” to breast cancer screening, Dr. Englander said.

Dr. Englander points to the number of women in the United States who refuse mammograms because they fear radiation or lack access to radiologists, and the millions of women who simply choose not to go for mammograms for a host of other reasons. It’s this gap where Dr. Englander sees a potential role for iBreastExam in the future. It could be performed by a general practitioner during a routine checkup as a pre-screening, to help identify masses that need to be investigated further, just as it’s used in India and other less developed countries.

On a winter afternoon in the southern Indian state of Karnataka, women lined up at their local primary health center in Hennagara village, about an hour and a half’s driver from Bengaluru, the capital.

The women had walked from neighboring villages after learning from community health care workers that there would be a free breast and cervical cancer screening camp. It is run by Biocon Foundation, one of the few nongovernment organizations in India that offer free cancer screening for the poor. For many of the women, it’s the first time they had heard about cancer and had the opportunity to be screened.

Dressed in a yellow and brown sari, Muniyallamma, 65, laid down on a gurney for an iBreastExam. A health care worker, Veda Kn, held the white and pink scanner in one hand and a cellphone in the other. She went over the four quadrants of each breast with the scanner. The device communicated wirelessly with the cellphone to display and store the findings in real time.

Green would indicate normal breast tissue, and red would mean a lesion was detected, suggesting the need for further testing at a nearby hospital.

Just a few minutes later Muniyallamma, who gave only her first name, got her results: She was in the clear.

“It was fine,” she said. “It was no problem. It didn’t hurt.”

Before Muniyallamma left the primary health center, Veda Kn showed her how to do her own breast examination and explained some of the common symptoms of breast cancer, including nipple discharge and swollen glands.

The device is currently in use in Mexico, Nepal, Myanmar, Indonesia, Oman and Botswana. In the next 12 months, its developers plan to expand its use to more Southeast Asian and African countries.

It takes four to eight hours to train a health care worker to use iBreastExam. Every health care worker undergoes a test before being certified.

In the absence of a nationwide population-based cancer screening program in India, the device is used in some private hospital chains, medical colleges, nongovernment organizations and state governments, and among community health care workers.

In 2016, the western Indian state of Maharashtra began the country’s first campaign to screen over 250,000 women using iBreastExam, with the state government committed to providing free or heavily subsidized follow-up measures when indicated, including ultrasound tests, biopsies and treatment. Mr. Shah is talking to other state governments, hoping the same screening campaign can be replicated across the country.

In Mexico, the country’s navy initiated a program to screen 140,000 women with the device. Foundations operated by pharmaceutical companies are also sponsoring iBreastExam. The Pfizer Foundation is supporting a pilot program to screen women in Myanmar, and the Bayer Cares Foundation is supporting screening in Brazil.

Each scan costs between $1 and $4, depending on how many scans the provider commits to. A regular mammogram in India costs at least $20.

But the rollout of iBreastExam in India has not been without problems, the biggest of which has been dealing with bureaucracy.

“In developing countries, if you really want to lower the burden of cancer, you’re going to have to work with — and partner with — the government and government institutions,” Mr. Shah said. “You don’t have a choice.”

In the context of India, that meant proving iBreastExam was not an ultrasound device — a highly controversial issue because ultrasound is commonly used to determine the sex of a fetus, and sex-selective abortion and female feticide have given India one of the world’s most skewed sex ratios.

While legislation was passed in 1996 banning the determination of a fetus’s sex, it has continued to thrive as doctors cash in on the trend. But that means health care professionals go through immense trouble to get an ultrasound device — or something that looks like one — approved for use.

“Doctors literally placed the iBreastExam on the tummy of a pregnant lady to see if it could pick up the gender of a child,” Mr. Shah remembered. “I said, ‘This is ridiculous,’” because the iBreastExam device cannot identify the sex of a fetus.

Nevertheless, he said, “People have great fear when a device looks remotely like an ultrasound.”

The core objective of a screening program is to improve survival rates. To that end, iBreastExam, like other community-based health screenings, relies on a strong referral system and linkage to care for women whose scans signal a need for further testing. “Any screening without follow-up is useless,” said Sumana Y, a doctor with Biocon.

India’s public health care system is marked by long waits, poor care and worker shortages. That’s why private hospitals, often out of reach for the poor, are so popular. Moreover, most cancer centers are in cities.

Dr. P. Raghu Ram, immediate past president of the Association of Breast Surgeons in India, said breast cancer is also an issue shrouded in stigma. The disapproval is rooted in a widespread belief that cancer is a sign that a woman has done something bad, in fear of death and in a taboo against discussing “women’s diseases.”

“India is facing a breast cancer tsunami,” Dr. Ram said. “The data reported is just the tip of the iceberg. I feel the major barrier in women getting opportunistic screening is it’s a taboo closet issue.” Nevertheless, Dr. Ram believes that the influence, reach and respect that community health care workers have in India could override the taboos and start to open discussions with women about cancer.

iBreastExam is not a panacea for the detection of breast cancer. Experts agree that a simple blood test is the ultimate goal. But for now, this tool can save lives and revolutionize breast cancer screening in many countries. “It’s all about access now,” Mr. Shah said. “Innovation is only as good as its reach.”