Blood test results may also lead to clinical trial to determine when to use MRI


For the last 12 years, doctors have monitored Pam Hilliard closely at Mercy Hospital Oklahoma City after tests determined she has a 20 percent chance of developing breast cancer during her lifetime based on abnormal cell growth called lobular neoplasia.
Since then, she has been an advocate for and participant in breast cancer-related clinical trials at Mercy in the hopes of finding answers for future generations.
This past June, she provided a blood sample to a current clinical trial aimed at developing a blood test that could detect breast cancer and help doctors decide whether or not a patient needs a biopsy or additional imaging tests.
“When I was asked to participate in the blood sample study, I was thrilled because I have adult daughters and granddaughters, and, quite frankly, if they can test with blood before having to go through any additional testing — biopsies or MRIs — it would be very beneficial,” said Hilliard, of Luther, Oklahoma.
Dr. Alan Hollingsworth, medical director of the Mercy Breast Center in Oklahoma City, hopes the clinical trial and the additional research work he is conducting will find the much-needed answers to make quicker, more effective diagnoses of breast cancer to save lives.
National Clinical Trial
Over the past 15 years, Hollingsworth has collected blood from more than 1,800 patients, distributing over 10,000 individual samples to researchers internationally.
About two years ago, he contributed about 500 of those samples to Provista Diagnostics, Inc., a private molecular diagnostics company in Scottsdale, Arizona. Those samples helped refine a proposed blood test prior to the launch a multi-site national clinical trial, including the Mayo Clinic (Rochester, Minnesota and Scottsdale campuses); Cleveland Clinic in Cleveland, Ohio; Scripps Polster Breast Care Center in La Jolla, California, Mercy Hospital Oklahoma City and several other health care organizations across the country.
The blood samples were drawn before patients had biopsies to diagnose possible breast cancer. The blood test and biopsy results will help researchers determine whether the blood test accurately detected whether or not patients had breast cancer.
If the blood test is deemed effective in detecting breast cancer, Hollingsworth said the test will help radiologists decide when to perform biopsies in cases where the mammography results are not conclusive enough to definitively require a biopsy. This would save patients from undergoing unnecessary biopsies.
‘Home Run’ Research
Based on the data from the multi-site clinical trial, which should be available this fall, Hollingsworth is taking the research a step further by comparing the results of mammograms and blood tests with MRI findings of patients at highest risk for developing breast cancer.
MRI uses strong magnetic fields and radio waves to produce detailed images, most commonly for the detection of tumors and soft tissue injuries, and is highly effective in finding breast cancer.
“Under this concept, all patients would get a mammogram and a blood test,” said Hollingsworth. “If the mammogram was negative and the blood test was positive, you’d then be a candidate for MRI. It wouldn’t say that cancer was definitely there, but it would be a good enough test to detect most of the cancers being missed by mammography.”
Based on strict screening guidelines, only patients who are considered at high risk for developing breast cancer, like Hilliard, are currently eligible for an MRI to screen for breast cancer. Hollingsworth said this excludes the vast majority of people who will get breast cancer who do not have risk factors (about 80 percent). He hopes that if the blood test is a good predictor of cancer, all patients will have access to MRI to screen for potential cancer, not just high-risk patients.
Hollingsworth plans to collect mammography, blood and MRI data from about 200 patients.
“Ideally, if we see 100 patients for screening and we detect three cancers by MRI, we want the blood results to be positive for cancer in those three patients and negative for the other 97 patients,” said Hollingsworth. “If you hit that kind of accuracy where the blood test is perfectly matched, then you’ve got a really good test, but it doesn’t have to be perfect in order to justify a major clinical trial.”
Hollingsworth hopes the results of this “proof of concept” study will be successful enough to lead to a multi-site clinical trial and eventually loosen or remove the strict guidelines on when patients can receive an MRI for breast cancer detection.
“The bottom line is we have a tool — MRI — that can find virtually every significant breast cancer out there and we’re limited in its use because it’s too expensive,” said Hollingsworth. “A screening blood test to complement mammography would revolutionize screening and provide access to MRI for all potential breast cancer patients, not just those deemed ‘at risk.’ This is ‘home run’ research, which means the odds of striking out are probably slightly greater than hitting a home run and there’s no in between. If it works, it will have a major impact on how we screen for breast cancer and provide earlier, more reliable diagnoses.”