Breast Imaging Research
Contact Information
Breast Imaging Research Lab
Wang Ambulatory Care Center, Suite 240
15 Parkman Street
Boston,
MA
02114
Phone: 617-724-3505
Frequently Asked Questions
Do I still need to get my regular mammogram even if I participate in research?
Yes. Participation in any of our studies does not replace your clinical mammogram. In each of the studies we compare the research results to the clinical mammogram.
Who do I contact to participate?
If you are already at the Avon Foundation Comprehensive Breast Evaluation Center for your mammogram appointment, ask the front desk if you could speak to someone in research before you receive your mammogram. If not, please call our office at 617-724-3505 to ask questions or schedule a time to come in that would coordinate with your already scheduled mammogram appointment.
How do I know if I qualify for these studies?
Each of our studies have been outlined further down on the page under "Research Projects" where it explains the eligibility criteria for each of the studies.
If I do not regularly get my mammogram at Mass General, can I still participate in the studies?
To participate in our studies you must be receiving a screening mammogram, diagnostic mammogram, or a biopsy at the Avon Foundation Comprehensive Breast Evaluation Center, Massachusetts General Hospital.
Where are you located?
Massachusetts General Hospital Imaging
Breast Imaging Research Lab
Avon Foundation Comprehensive Breast Evaluation Center
Wang Ambulatory Care Center - Suite 240
15 Parkman Street
Boston, MA 02114
Do I have to pay for the extra imaging in the study?
No. There is no additional charge for participating in research projects.
Will my personal information be protected?
Yes. The Health Insurance Portability Accountability Act, known as HIPPA, which is the Federal Privacy Act enacted by congress in 1996, governs who can gain access to your personal information. The Institutional Review Board (IRB) of Mass General Hospital has approved our studies and precautions will be taken to both safely keep and protect this information.
May I participate in more than one of the studies?
Yes, you may. However, it may not be possible to be involved in some studies all in the same visit to the MGH Avon Foundation Comprehensive Breast Evaluation Center. We most often recruit volunteers while they are here for their regular breast evaluation. Some of the criteria followed for various studies may require a return visit if you want to participate.
Will the results from my research study be used in my clinical care at the Avon Foundation Comprehensive Breast Evaluation Center?
Usually not, but sometimes they will; you will be informed ahead of time if they will be used. While most of the studies involve new imaging techniques that are not yet FDA approved, it is certain that your clinical care will not come directly from any research results. However, for some of the studies your clinical care would be altered if something were noticed on the research imaging.
Research Projects
Digital Breast Tomosynthesis (DBT) versus Conventional Two View Mammography (CTVM)
What is this study?
The purpose of the research study is to compare a new mammography imaging system with the standard system. The new research mammography system is being investigated as a method of improving mammography images. The goal is to improve the ability to identify a lesion and determine if the lesion is cancerous or not. It is hoped the new method, called digital breast tomosynthesis (DBT) may also improve detection of breast cancer.
How long does this study last?
If you agree to participate in this research study you will have an additional imaging of each breast using the tomosynthesis system. DBT is similar to conventional mammography; however, images are obtained over a sweep to allow better imaging of a suspicious area. The DBT study should require approximately 10 minutes to perform. The images obtained with each examination will be interpreted independently by a board-certified radiologist with special expertise in mammography. We ask that you return one year later for your annual mammogram. A standard screening mammogram will be taken as would be performed as part of routine health care.
What are the risks of the study?
If you agree to participate in this research study you will have an additional imaging of each breast using the tomosynthesis system. DBT is similar to conventional mammography; however, images are obtained over a sweep to allow better imaging of a suspicious area. The DBT study should require approximately 10 minutes to perform. The images obtained with each examination will be interpreted independently by a board-certified radiologist with special expertise in mammography. We ask that you return one year later for your annual mammogram. A standard screening mammogram will be taken as would be performed as part of routine health care.
Are there benefits to taking part in the study?
There may be some direct benefit to you by participating in this research study. In a pilot study DBT has been shown to be better able to separate lesions from normal breast tissue. There is a possibility that DBT mammography may be more sensitive and specific than standard mammography in detecting early breast cancer. Your participation in this study may help others by providing a more precise evaluation of the accuracy of digital mammography in detecting breast cancer.
What about confidentiality?
Records will be kept in a confidential form at this institution and in a computer file. Organizations that may inspect and/or copy your research records for quality assurance and data analysis include groups such as the Food and Drug Administration (FDA), the National Cancer Institute (NCI), qualified representatives of applicable mammography manufacturers. Your personal information maybe disclosed if required by law.
What are the costs?
Only the DBT imaging will be performed at no cost to you. The cost of annual screening mammography and any other costs that may occur because of your participation in this study will be your responsibility or that of your insurance carrier, because those costs are usual clinical care. No compensation for participation will be given.
Contact Information
If you are interested in learning more or would like to participate, please contact Breast Imaging Research Division at 617-724-3505.
Electrical Impedance of the Breast I
What is this study?
The purpose of this research study is to investigate a new screening technique that may detect breast cancer earlier than is now possible. This technique is since electrical current passes through tumor tissue more easily than it does through normal tissue (that is, a tumor is characterized by higher electrical conductivity). The new technique, called impedance scanning, sees the changed electrical characteristics of tumors as a beacon. It does this by using an investigational device that scans for tumors in sonar-like fashion by sending electrical currents through the breast from the skin surface and then analyzes the electrical fields created by these currents. Preliminary studies have been performed that have shown that very small tumors are detectable using this method of impedance scanning. This study should provide the additional information needed to determine if the diagnostic accuracy of the new technique is high enough to make it available for general use.
How long does this study last?
It is estimated that about 45 minutes will be required for this research study. The actual scan procedure takes only about 10 minutes. First, informed consent will be obtained. Then the research assistant will obtain information about your medical history and a technologist will perform the impedance scan procedure.
What are the risks of the study?
The risk of electrical shock is virtually eliminated by using a low voltage system, comparable to the output of standard batteries. Electrical currents applied during impedance scanning will be beneath the level you can feel. In addition, these small currents should not affect your heart. If you have breast skin disease, are pregnant or nursing, or have a heart pacemaker, you should not participate in this study.
Are there benefits to taking part in the study?
The Z-Tech HEDA system is not currently FDA approved. This study is being conducted solely for scientific evaluation of the safety and effectiveness of this technique and we cannot guarantee any benefit to you, the volunteer.
What about confidentiality?
Records will be kept in a confidential form at this institution and in a computer file at the headquarters for the study's sponsor, Z-Tech, Inc. Your identity will be protected on all data sent to Z-Tech, Inc.
What are the costs?
The impedance scan will be provided to you at no cost and you will receive no payment for taking part in this study.
Contact Information
If you are interested in learning more or would like to participate, please contact Breast Imaging Research Division at 617-724-3505.
Tomographic Optical Breast Imaging
What is this study?
Tomographic Optical Breast Imaging (TOBI) is based on the theory that early physiological changes of blood circulation, specific for early stages of cancer, can be revealed as the contrast of blood volume and oxygen saturation difference between the surrounding normal tissue and the healthy tissue. The potential for TOBI as a diagnostic tool is to non-invasively identify and differentiate benign from malignant breast lesions. It can be used in conjunction with standard x-ray mammography to provide functional images that are then fused with the x-ray structural images. It is expected that the combination of x-ray and TOBI will be more powerful in detection, localization and characterization of tumors than either indicates separately, and the potential of TOBI as a stand-alone modality is also significant. If you agree to participate in this study, you will receive one mammogram and optical scan, after your clinical mammogram has been completed.
How long does this study last?
It is estimated that about 15 minutes will be required for this research study, after you have your clinical mammogram. First, informed consent will be obtained. Then the research assistant will obtain information about your medical history and a technologist will perform the procedure.
What are the risks of the study?
The amount of radiation to which you will be exposed is approximately 80 millirem (mrem) in addition to your clinical mammogram. A millirem is a unit of measure of radiation dose. This amount of radiation is equal to about 26% of the annual background radiation one is exposed to each year from the earth and the sky. The power from the lasers that are shone into the breast are within regulated standards. The amount of light is much less than the intensity of light you would receive during an outdoor walk on a sunny day.
Are there benefits to taking part in the study?
There are no direct benefits to you if you decide to participate in this study. However, there may be a benefit to society in general from the knowledge gained from this study.
What about confidentiality?
Records will be kept in a confidential form at this institution. Your identity will be protected.
What are the costs?
There will be no cost to you and you will receive no payment for taking part in this study.
Contact Information
Once the patient's mammogram is complete, but prior to any biopsies, please contact Breast Imaging Research Division at (617) 724-3505 and they will complete all the consenting and eligibility criteria.
Electrical Impedance of the Breast II
What is this study?
The purpose of this research study is to investigate a new screening technique that may detect breast cancer earlier than is now possible. This technique is called Electrical Impedance Tomography (EIT) and is based on the fact that electrical current passes through tumor tissue more easily than it does through normal tissue. The new technique focuses on the changed electrical characteristics of tumors. The EIT scans for tumors by sending electrical currents through the breast from the skin surface. Preliminary studies have been performed that have shown that very small tumors are detectable using this method of scanning. This study could provide the additional information needed to determine if the diagnostic accuracy of the new technique is high enough to make it available for general use.
How long does this study last?
It is estimated that about 30 minutes will be required for this research study. The actual mammographic scan procedure takes only about 10 minutes. First, informed consent will be obtained. The research assistant will then obtain information about your medical history and a technologist will perform the impedance tomography procedure.
What are the risks of the study?
There is low risk to participating in this study. Electrical currents applied during impedance scanning will be beneath the level you can feel. The risk of electrical shock is virtually eliminated by using a low voltage system, comparable to the output of standard batteries. In addition, these small currents should not affect your heart. If you are pregnant or nursing, or have a heart pacemaker, you should not participate in this study.
Are there benefits to taking part in the study?
The Electrical Impedance Tomography system is not currently FDA approved. This study is being conducted solely for scientific evaluation of the safety and effectiveness of this technique and we cannot guarantee any benefit to you, the volunteer.
What about confidentiality?
Records will be kept in a confidential form at this institution and in a computer file at Rensselaer Polytechnic Institute, the institute conducting this study. Your identity will be protected on all data sent to Rensselaer Polytechnic Institute.
What are the costs?
The impedance scan will be provided to you at no cost and you will receive no payment for taking part in this study.
Contact Information
If you are interested in learning more or would like to participate, please contact Breast Imaging Research Division at (617) 724-3505.
Group Members
- Richard Moore - Director, Breast Imaging Research
- Donna Burgess - Research Clinical Supervisor
- Jennifer Curry - Clinical Research Project Manager
- Angie Burke - Clinical Research Project Manager
- Dianne Scourletis. RT(M) - Research Mammographer
- Jayne Cormier, RT(M) - Research Mammographer
- Lynne Jameson-Meehan RT(R) - Research Mammographer
- Avital Levy - Clinical Research Assistant
- David Boody-Alter - Clinical Research Assistant
- Anila Burimi - Clinical Research Assistant
- Chanelle Bray - Clinical Research Clerk
Publications
- Kopans DB, Halpern E, Hulka CA. Statistical power in breast cancer screening trials and mortality reduction among women 40-49 with particular emphasis on the national breast screening study of canada. Cancer 1994;74:1196-1203.
- Kopans DB. Mammography Screening and the Controversy Concerning Women Aged 40-49. Rad Clin N Am. 1995;33:1273-1290.
- Niklason LT, Christian BT, Niklason LE, Kopans DB, Castleberry DE, Opsahl-Ong BH, Landberg CE, Slanetz PJ, Giardino AA, Moore R, Albagli D, DeJule MC, Fitzgerald PE, Fobare DF, Giambattista BW, Kwasnick RF, Liu J, Lubowski SJ, Possin GE, Richotte JF, Wei C-Y, Wirth RF. Digital Tomosynthesis in Breast Imaging. Radiology 1997;205:399-406.
- Kopans DB. The Breast Cancer Screening Controversy: Lessons to be Learned. J Surg Onc 1998;67 :143-150.
- Feig SA, D'Orsi CJ, Hendrick RE, Jackson VP, Kopans DB, Monsees B, Sickles EA, Stelling CB, Zinninger M, Wilcox-Buchalla P. American College of Radiology guidelines for breast cancer screening. Am J Roentgenol 1998 Jul;171(1):29-33
- Kopans D., Wu T. and Moore R., "Digital Mammography", Diagnostic Imaging, 6, 42-48 2001.
- Wu T., Stewart A., Stanton M., McCauley T., Phillips W., Kopans D., Moore R., Eberhard J., Opsahl-Ong B., Niklason L., Williams M.B. "Tomographic mammography using a limited number of low-dose cone-beam projection images", Medical Physics, 30(3), 365-380, 2003.
- Li A., Miller E. L., Kilmer M. E., Brukilacchio T. J., Chaves T., Stott J., Zhang Q., Wu T., Chorlton M., Moore R. H., Kopans D. B., and Boas D. A., "Tomographic Optical Breast Imaging Guided by 3-D Mammography," Applied Optics, 42(25), 5181-5190, 2003.
- Wu T., Moore R., Rafferty E., Daniel Kopans, Zhang J., Meleis W., and Kaeli D., "Digital tomosynthesis mammography using a parallel maximum likelihood reconstruction method", Proc. SPIE Medical Imaging, 5368:1-11, 2004.
- Reiser I., Sidky E.Y., Nishikawa R.M., Giger M.L., Rafferty E.A., Kopans D.B., Moore R.H., Wu T., "Reconstruction-independent method for computerized mass detection in digital tomosynthesis images of the breast", Proc. SPIE Medical Imaging, 5370:833-838, 2004.
- Reiser I., Nishikawa R.M., Giger M.L., Rafferty E.A., Kopans D.B., Moore R.H., Wu T., "Computerized detection of mammographic masses in tomosynthesis image slices using radial-gradient-index filtering", Proc. of CARS 2004.
- Wu T., Moore R., Rafferty E., Daniel Kopans, "A comparison of reconstruction algorithms for digital breast tomosynthesis", Medical Physics, 31(9), 2636-2647, 2004.
- I. Reiser, R. M. Nishikawa, M. L. Giger, T. Wu, E. Rafferty, R. H. Moore, D. B. Kopans, "Computerized Detection of Mass Lesions in Digital Breast Tomosynthesis Images Using Two- and Three Dimensional Radial Gradient Index Segmentation", Technology in Cancer Research and Treatment, 3(5) 437-442, 2004.
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