CLINICAL TRIAL TO COMPARE SCREENING BREAST MRI TO SCREENING MAMMOGRAPHY IN CANCER DETECTION 

Dearborn County Hospital will soon initiate one of the most significant and lifesaving clinical trials ever conducted in regard to the detection of breast cancer in women.  This August, DCH will begin the first ever Screening Breast Magnetic Resonance Imaging (MRI) Program for the earliest possible detection of breast cancer.  Through this project, Dearborn County Hospital is creating and implementing a scientific clinical research study to determine if Screening Breast MRI is more accurate than screening mammography for the early detection of breast cancer.

Current statistics reveal that 1 in 20 women who have a normal mammogram actually have a current breast cancer that is detectable by using Breast MRI.  This inability to detect the cancer is not the result of inferior mammography equipment or inadequate technique or interpretation, rather it is due to the increased accuracy of Breast MRI being able to detect more and/or smaller cancers.

“We feel very strongly that our findings will ultimately help prolong or save the lives of millions of women,” explained Roger Howard, DCH Director of Clinical Services and Facilities.  “In 2008, mammograms were performed on more than 4,800 women at our three DCH mammography sites.  Given there are thousands of mammography sites across the country, the potential number of women positively affected by this advance could be enormous.”

“When you think of the effect breast cancer has on our community collectively, you can see how extremely important this study is to everyone,” added Peter V. Resnick, DCH Executive Director. “Breast cancer not only affects the patient’s health and quality of life, but it affects their family, friends and even their employer or employees.”

Breast cancer is the second leading killer of women in America.  Current American Cancer Society statistics indicate that 1 in 7 women will face breast cancer in their lifetime and this number may increase to 1 in 5 in the future.  It is estimated that 40,000 women die each year from breast cancer.

Asymptomatic women who meet the study guidelines (please see sidebar) and who have had a recent normal screening mammogram may volunteer to participate in the clinical trial. Those agreeing to take part will be scheduled for a Screening Breast MRI at DCH using the most advanced technology, the General Electric Signa Vibrant 1.5T magnet with Vangard breast imaging table featuring variable coil geometry for optimal positioning of the patient.

The actual screening will take approximately 30 to 40 minutes.  Halfway through the examination, a single injection of a contrast agent will be given in a vein in the participant’s arm.  Those taking part in the study should not experience any discomfort or be exposed to any risks above and beyond those normally associated with the administration of contrast agents and/or an MRI procedure.  MRI does not utilize X-rays to obtain images.

Following the scan, the images will be sent to the Breast MRI Institute of Flint, Michigan, where Dr. David Strahle, our principal investigator, along with his specially trained staff of Radiologists will interpret the Breast MRI. A comparison of the MRI is then made to the conventional mammogram to determine if the Breast MRI detected an abnormality not seen on the mammogram.  A complete report is forwarded to the participant and her personal physician.

“Because the individual is taking part in research, the Screening MRI and Radiologist’s interpretation will be provided free of charge,” noted Mr. Resnick.  “This will allow us to have a broad cross-section of women take part.

“It’s not often that a community hospital initiates such a significant clinical study,” stated Mr. Resnick.  “Most clinical trials are conducted through major research or teaching facilities in large metropolitan areas.  Conducting the study at DCH will allow a large number of women in our region to take part in a significant if not groundbreaking clinical trial.  Hopefully, many women will want to participate, allowing our study to be completed in a timely manner.”

“It has been shown that the earlier breast cancer is detected, the better the outcome for the patient,” elaborated Mr. Howard.  “Currently, mammography does not detect a significant number of cancers that can be detected by MRI.  These cancers may be found later by mammography leading to prolonged intense treatment.

“While our primary goal is to help prolong or save the lives of women in the region, our secondary goal is to determine if Screening Breast MRI is superior to screening mammography in early cancer detection,” he continued.  “Our hope is this study will ultimately lead to the establishment of MRI as the standard modality for breast cancer screening, whether used alone or in combination with limited mammography.  It should help open the door for Screening MRI coverage by insurance plans, just as mammography is covered by most plans today.”

“Implementing this study and seeing it through to fruition will be a major undertaking both financially and in hours utilized for the project.  As a community hospital, we could never have initiated such a project if it were not for our community partners, clinical colleagues and the foresight of our Board of Trustees,” expressed Mr. Resnick.

“Dearborn County Hospital is extremely grateful to Mayor Cunningham and the Lawrenceburg City Council and Administration for their enthusiastic support of this study through their donation of $750,000,” said Mr. Resnick.  “In addition, the Dearborn Community Foundation, Inc., awarded $100,000 to DCH for the project from the City of Lawrenceburg Community Grant Program.  These grants coupled with available hospital funds allowed DCH to purchase the necessary equipment for the study at a cost of $1.125 million.”

Additional funding was provided to the study by the Dearborn County Hospital Auxiliary and Dearborn County Hospital Foundation, which donated $50,000 and $25,000 respectively, as well as the United Way which donated $5,000 and the Ohio County Community Foundation which contributed $3,000.

“To help make the study financially possible, the Radiologists from the Breast MRI Institute will interpret the images for less than half of their usual charge.  Donations from the above sources will be used to help offset the balance of these fees,” Mr. Howard explained.

“The hospital will pay for equipment maintenance and fixed and miscellaneous expenses pertaining to the screenings and study, however, it will not receive any financial compensation,” he added.

“Dearborn County Hospital is extremely grateful for both the encouragement and the financial support of these organizations and clinical partners,” stated Mr. Resnick.  “The community at large should also appreciate the decisions these organizations have made to support this study as it may ultimately lead to prolonging or saving thousands of lives, possibly even the lives of their loved ones or neighbors.

“Every once in a great while, the opportunity presents itself to do something for the greater good, to take part in something extraordinary ... something that will have a lasting effect on many people,” concluded Mr. Resnick.  “For DCH, Screening Breast MRI is that opportunity.  We at DCH are extremely hopeful that our clinical study will help lead to a longer and better quality of life, not just for our patients, but for all women everywhere.”