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Screening

Breast Cancer Screening Program for High-Risk Women

A Multi Modality Surveillance Program for Women At High Risk for Breast Cancer (NCT00989638)

Summary

Combining multiple screening techniques may improve a woman's chance of having a small cancer or pre-cancer found early. The goal of this study is to develop a coordinated, standardized screening program for the early detection of breast cancer in high-risk women using mammography, breast magnetic resonance imaging (MRI), and clinical breast exam. The study will also evaluate quality of life and compare MRI and mammography. This trial is open to women who are at high risk because they have one of the following: BRCA1, BRCA2, or another known mutation; a personal history of breast cancer before age 35; a personal history of DCIS before age 35 and a mother or sister with breast or ovarian cancer before age 50; are cancer survivors who had chest radiation before age 30; or are of African ancestry and have a relative who had breast cancer before age 40.

Ovarian Cancer Screening for High-Risk Women

Ovarian Cancer Early Detection Screening Program (NCT01292733)

Summary

A woman who has a personal history of breast cancer and/or a family history of breast or ovarian cancer has an increased risk of developing ovarian cancer. There is currently no reliable ovarian cancer screening test. Cancer antigen-125 (CA125) is a protein that can easily be measured by a blood test and that is often elevated in women with ovarian cancer. However, it is not accurate enough to be used as a screening test on its own. Pelvic ultrasound uses sound waves to create an image of the ovaries, but it is not good at determining whether a mass that might be detected is really ovarian cancer. The purpose of this study is to investigate the effectiveness of combining CA125 testing with pelvic ultrasound for early detection of ovarian cancer in high-risk women. To be eligible, women must be at high risk for ovarian cancer because of their own and/or their family's cancer history.
This is a Phase O trial

Ovarian and Breast Cancer Screening and Prevention

Cancer Screening and Prevention Program for High Risk Women (NCT00849199)

Summary

Women who are at high-risk for developing breast and ovarian cancer require cancer screening and education programs that address their unique needs and concerns. The NYU Cancer Institute at New York University Medical Center is designing a new program for high-risk women. The purpose of this study is to determine whether the program's questionnaire directs high-risk women to the appropriate educational materials and ensures they obtain the proper tests and speak with the right specialists. To be eligible for this study, individuals must have a personal or family history of breast or ovarian cancer or have a perceived increased risk of breast or ovarian cancer.

Evaluating the SoftVue Technique for Breast Imaging

Clinical Data Collection for Initial Evaluation of SoftVue: a Novel Ultrasound Breast Scanner (NCT01698658)

Summary

SoftVue is a new technique that may improve breast cancer detection. It involves submerging the breast in warm water during an ultrasound procedure, which creates detailed, three-dimensional images of the breast. This trial will enroll women scheduled for mammogram, breast ultrasound and/or breast MRI to see how the images SoftVue provides compare to those provided by these other methods.

Ultrasound in Detecting Lymph Node Involvement

Lymph Node Evaluation in the Axilla of Symptomatic Older Women During Breast Sonography. (NCT01681901)

Summary

Ultrasound uses sound waves to make a picture of the tissues inside the breast. It does not use X-rays or other types of radiation. It is currently used to see whether a breast lump is filled with fluid (a cyst) or if it is a solid lump. It may also be helpful in determining how far the cancer has spread. The goal of this study is to develop a reliable and consistent set of guidelines for using ultrasound to assess the axillary lymph nodes (the lymph nodes under the arm) of patients who may have breast cancer that has spread to these nodes. To be eligible, women must have had a mammogram and have been referred for a breast ultrasound.

Using Light-Scattering Spectroscopy to Analyze Breast Tissue

Light-Scattering Spectroscopy for the Detection of Stage II-III Breast Cancer: A Pilot Study (NCT01755208)

Summary

A doctor will perform a breast biopsy to learn more about an area of concern seen on a mammogram. Light-scattering spectroscopy (LSS) is an imaging technique that does not require removal of tissue samples and can provide quick results. LSS may be able to identify cell abnormalities more effectively than a biopsy. This study is investigating whether light-scattering spectroscopy can differentiate between women who have stage II or III breast cancer and women who do not have breast cancer. To be eligible for this study, a woman must be scheduled to have a mammogram at the University of Southern California.

Comparison of Whole Breast Screening Ultrasound and Contrast Enhanced Mammography

Comparison of Whole Breast Screening Ultrasound and Contrast Enhanced Mammography for Supplemental Breast Cancer Screening (NCT02310698)

Summary

Researchers are trying to identify the best imaging technologies to use along with mammography. Breast ultrasound is sometimes used as an additional test. Studies have shown that it can detect cancers that are not seen on regular mammography. Contrast Enhanced Digital Mammography (CEDM) is an FDA-approved form of mammography. It uses a dye injected into a vein to "highlight" areas of increased blood supply, which may indicate the presence of cancer cells. CEDM has been shown to detect cancer cells that are not seen on a regular mammogram. This study is comparing the effectiveness of CEDM and breast ultrasound when used along with mammography. To be eligible, a woman must be scheduled to receive contrast enhanced digital mammography alone or with whole breast screening ultrasound or full field digital mammography on the same day or within 30 days of one another.

Comparing Two Screening Methods for High-Risk Women

Comparison of Contrast Enhanced Mammography to Breast MRI in Screening Patients at Increased Risk for Breast Cancer (NCT01716247)

Summary

Magnetic resonance imaging (MRI) is currently used to screen high-risk women. Contrast Enhanced Spectral Mammography (CESM) is a special type of mammogram that creates two separate images of each breast. One of the images is the same as a standard mammogram. The other shows areas of increased blood supply, which could indicate the presence of a breast tumor. This study is comparing the use of CESM and MRI to detect small tumors in high-risk women. To be eligible, participants must be scheduled to receive a breast MRI because they are considered to be at high risk for developing breast cancer or have a history of breast cancer.

A Blood Test for Circulating Tumor Cells for Cancer Screening

Circulating Tumor Cells (CTCs): A Potential Screening Test for Clinically Undetectable Breast Carcinoma (NCT01322750)

Summary

Scientists are trying to identify effective new techniques for breast cancer screening. Researchers now believe that breast cancer cells can leave the breast and move through the blood stream to other parts of the body before the tumor is even clinically detectable. Reliable and accurate detection of these circulating tumor cells (CTCs) is now possible with a simple blood test. The goal of this research is see whether a blood test for CTCs could provide a simple, reliable, cost-effective form of breast cancer screening. The aim of this specific study is to evaluate whether individuals with CTCs and no other signs of malignancy have clinically undetectable breast cancer. To be eligible, participants must be military health care beneficiaries.

Using 3D Mammography to Evaluate Breast Tumors

Comparison of Carbon Nanotube X-ray Stationary Digital Breast Tomosynthesis and 2-D Digital Mammography in Patients With Known Breast Lesions. (NCT01773850)

Summary

Tomosynthesis is an FDA-approved imaging technique that can create a 3-D image of the breast. It does not require as much breast compression during imaging, making it less painful than conventional mammography. Studies suggest it may also be more accurate than conventional mammography. The goal of this study is to see if radiologists can confidently and accurately identify breast tumors identified through conventional mammography with breast tomosynthesis. To be eligible, participants must have received a breast cancer diagnosis following a conventional mammogram and be scheduled to have a clinical surgical breast biopsy.

Breast Cancer Screening with Ultrasound and Mammography

Earlier Breast Cancer Detection Using Automated Whole Breast Ultrasound With Screening Mammography, Including Cost Comparisons (NCT00649337)

Summary

Abnormalities can be more difficult to detect on a mammogram when women have dense breast tissue. Ultrasound imaging is a noninvasive medical test that produces a picture of the internal structures of the breast and is used to complement other screening tests, such as mammography. SonoCine is an innovative exam that uses a standard ultrasound machine to take a video of the entire breast. The purpose of this study is to determine whether adding whole breast ultrasound with SonoCine to annual screening mammography is more effective in women with dense breast tissue than mammography alone. To be eligible, participants must not have had a screening mammogram within 10 months of study entry or have been diagnosed with breast cancer within the last year.

Using DWI with MRI for Breast Cancer Detection

A MULTI-CENTER STUDY EVALUATING THE UTILITY OF DIFFUSION WEIGHTED IMAGING FOR DETECTION AND DIAGNOSIS OF BREAST CANCER (NCT02022579)

Summary

Magnetic resonance imaging (MRI) is currently used to screen high-risk women. Diffusion-weighted imaging (DWI) calculates a measure of how water moves through tissue. Because water moves at different rates through healthy breast tissue and cancerous breast tissue, incorporating DWI into conventional breast MRI may decrease false positives and reduce preventable biopsies. In this study, researchers will investigate the accuracy of MRI combined with DWI in women with breast tumors that were identified on MRI. The DWI will be done at the time of the MRI, adding an additional two minutes to the MRI procedure.

Breast Health Coaches for Older African-American Women

Evaluating Coaches for Older Adults Cancer Care and Health (NCT01613430)

Summary

Studies have shown that African-American women are less likely than white women to get regular mammograms, which increases their chances of being diagnosed with a later stage breast cancer. A coach is an individual whom the participant trusts to navigate her through the health care system. Researchers believe that for older women, a coach who is a member of her extended family may be more effective than a coach who she has not met before. The overall goal of this study is to compare the effectiveness of trained health coaches with traditional health education efforts to increase breast cancer screening in older African-American women. To be eligible, participants must be African American, residents of Baltimore City or Prince George's County, Maryland, 65 to 74 years of age, and enrolled in Medicare Parts A and B.

A Study of a New Imaging Device to Diagnose Breast Cancer

Measurements of Breast Tissue Optical Properties (NCT00540540)

Summary

Researchers are developing new ways to diagnose breast cancer. Frequency-Domain Photon Migration (FDPM) is a new technology that uses near infrared (NIR) light to scan breast tissue. It provides information about breast cells that researchers may be able to use to identify breast tumors. This study will help researchers learn more about the use of FDPM for breast imaging. It is not designed to diagnose breast tumors and volunteers will not be provided with any specific information about the results of their FDPM test.

A New Imaging Technique for Breast Cancer Detection in High-Risk Women

Diffusion Weighted MR Imaging of the Breasts in Women at High Risk of Breast Cancer: A Pilot Study (NCT01938157)

Summary

Diffusion-weighted imaging develops a picture of the breast by assessing the random motion of water molecules in breast tissue. Studies have found that water diffusion is abnormal in breast tumors. This means diffusion-weighted imaging may be a helpful tool for identifying breast tumors. This study is evaluating whether diffusion-weighted MR imaging can identify breast tumors in women at high risk of developing breast cancer who are having an MRI.

Contrast-Enhanced Spectral Mammography and MRI for Screening High-Risk Women

Dual-energy Contrast-enhanced Digital Subtraction Mammography (CESM) as a Tool to Screen High Risk Women for Breast Cancer: a Comparison to Screening Breast MRI (NCT02275871)

Summary

Mammography is the recommended screening test for early breast cancer detection. Magnetic Resonance Imaging (MRI) is recommended as an additional screening tool for some women who are at high risk of developing breast cancer. Contrast-Enhanced Spectral Mammography (CESM) is an FDA approved tool used to identify inconclusive findings on a mammogram or ultrasound because it shows areas of increased blood supply that are typical of breast tumors. Early studies suggest CESM may be better than MRI for screening high-risk women. In this study, high-risk women will receive both MRI and CESM so that researchers can determine which improves early detection.

Comparing CT scans to Mammography and 3D Tomosynthesis for Breast Cancer Detection

Computed Tomography Versus Standard 2D Mammography Versus 3D Tomosynthesis (NCT01852032)

Summary

Researchers are studying how well breast CT scans can detect breast tumors. A CT scan (also called a CAT scan, or computerized tomography scan) is an X-ray technique that creates 2-dimensional images of the body’s internal organs. Preliminary studies suggest that breast CT may be able to detect smaller breast tumors than mammography. Breast tomosynthesis is an FDA-approved imaging technique that produces standard 2-D mammography and 3-D tomosynthesis images. This study is comparing the number of lesions detected by an investigational breast CT scanner with the number detected by mammography and breast tomosynthesis in women suspected of having breast cancer. The study is also comparing the estimated radiation dose of these procedures.
This is a Phase O trial

Studying New Options for Breast Cancer Screening

Simulated Screening Study of Combined Digital X-Ray, Ultrasound and Photoacoustic Breast Imaging (NCT01807754)

Summary

Digital mammography and hand-held ultrasound are commonly used to find and evaluate breast masses. However, they often result in false positive results, which require further follow-up tests. Digital breast tomosynthesis (DBT) is a new breast imaging system. Studies suggest it may help doctors more effectively pinpoint the size, shape and location of a breast mass. Three-dimensional automated ultrasound (AUS) is another type of imaging system. It uses sound waves to create 3-D images of breast tissue. Photoacoustic imaging, another technique, uses laser light to create temperature changes in the breast that can be detected by small microphones placed against the skin. In this study, women who have had an abnormal mammogram will have all three imaging tests—DBT, AUS and photoacoustic imaging. The researchers will compare the test results to see if the call back rate differs when using the DBT result alone compared to using the results from all three tests.
This is a Phase O trial

A New Type of MRI for Breast Cancer Screening

High Resolution 3D Diffusion-weighted Breast MRI (NCT01315106)

Summary

High resolution 3D diffusion-weighted breast MRI is a new technique for breast cancer screening. Diffusion-weighted breast imaging develops a picture of the breast by assessing the random motion of water molecules in breast tissue. Researchers have found that water diffusion is abnormal in breast tumors. This leads them to believe that diffusion-weighted imaging may provide a new way to identify breast tumors. In this study, women will have a standard breast MRI and then an MRI using the new technique. The images from both MRIs will be compared with the results of the pathology report, allowing the researchers to determine which technique identifies more breast tumors.