Digital Breast Tomosynthesis (DBT) vs Conventional Two View Mammography (CTVM)
Electrical Impedance of the Breast I
Tomographic Optical Breast Imaging
Electrical Impedance of the Breast II

Optical Imaging of the Breast ( Download .pdf )






Digital Breast Tomosynthesis (DBT) vs 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 lesionis 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 areobtained 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 youreturn one year later for your annual mammogram. A standard screening mammogram will be taken aswould be performed as part of routine health care.

What are the risks of the study?
The risks associated with mammograms are low. Having the DBT mammogram in addition to the standard mammogram will give a small, additional amount of radiation to each breast. This is similar tothe amount of natural radiation one would receive from living at a high altitude in the mountains for approximately one year. There is also the risk that the study will falsely indicate an abnormality that could cause unnecessary anxiety and/or extra procedures to be performed. The additional DBT mammogram may cause discomfort by the compressions being repeated.

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 thatmay occur as a result of your participation in this study will beyour responsibility or that of your insurance carrier, because those costs are usual clinical care. No compensation for participation will be given.

If you are interested in learning more or would like to participate in thisresearch study, please see the front desk BEFORE you have your mammogram.




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 based on the fact that 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 oftumors as a beacon. It does this by using an investigational device that scans for tumors in sonar-like fashion bysending electrical currents through the breast from the skin surface and then analyzes the electrical fields createdby 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 forgeneral use.

How long does the 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 this study?
The Z-Tech HEDA system is not currently FDA approved. This study is being conducted solely for scientific evaluation of the

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.

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 the 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 this 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.

Once the patient’s mammogram is complete, but prior to any biopsies, please contact Tina (30378) 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 the 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.   Then the research assistant will 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 this 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.

If you are interested in learning more or would like to participate, please see the front desk.

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