Molecular Breast Imaging: A Novel Technology for Detection of Malignant Breast Lesions
NCT ID: NCT01004666
Last Updated: 2013-01-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
500 participants
OBSERVATIONAL
2009-10-31
2015-10-31
Brief Summary
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Detailed Description
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In Israel , genetic high- risk for breast cancer is highly relevant. We will offer the new imaging technology, to a wide patients population/group from all over Israel , in which the referring physician and/or the breast-imaging physician will look for additional imaging modality. Therefore this stage will include:
* Women with equivocal findings on Mammography, US and/or MRI
* Women with discrepancy between CBE(clinical breast examination)and breast imaging
* Women with dense breast
* Women in high risk for Breast Cancer
Before the imaging procedure each woman will need to fill detailed questionnaire, specific for the study, that will include information on her medical history, family history, gynecology information, menstrual phase, use of hormones etc.
The images will be correlated with other imaging tests including mammography, US and MRI. We will follow up the women for at least 6 months, including biopsy findings and or other clinical and imaging exams.
This phase will include 500 women.
Conditions
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Study Design
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COHORT
PROSPECTIVE
Study Groups
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Women with equivocal findings on Mammography, US and/or MRI
Women with equivocal findings on Mammography, US and/or MRI
No interventions assigned to this group
Discrepancy between clinical examination and imaging
Women with discrepancy between clinical examination and breast imaging
No interventions assigned to this group
Women with dense breast
Women with dense breast
No interventions assigned to this group
Women in high risk for Breast Cancer
Women in high risk for Breast Cancer. Including patients with genetic high risk and/or strong family history.
No interventions assigned to this group
Eligibility Criteria
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Inclusion Criteria
* Equivocal breast lesions.
* Dense breast tissue.
* High-risk for breast cancer
Exclusion Criteria
* Pregnancy.
* Patients unable to understand and sign an informed consent
25 Years
FEMALE
Yes
Sponsors
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Tel-Aviv Sourasky Medical Center
OTHER_GOV
Responsible Party
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Principal Investigators
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Einat Even-Sapir, MD, PhD
Role: PRINCIPAL_INVESTIGATOR
Tel Aviv Sourasky Medical Center, Tel Aviv, Israel
Locations
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Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center
Tel Aviv, , Israel
Countries
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Central Contacts
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Facility Contacts
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References
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Hruska CB, Phillips SW, Whaley DH, Rhodes DJ, O'Connor MK. Molecular breast imaging: use of a dual-head dedicated gamma camera to detect small breast tumors. AJR Am J Roentgenol. 2008 Dec;191(6):1805-15. doi: 10.2214/AJR.07.3693.
Hruska CB, Boughey JC, Phillips SW, Rhodes DJ, Wahner-Roedler DL, Whaley DH, Degnim AC, O'Connor MK. Scientific Impact Recognition Award: Molecular breast imaging: a review of the Mayo Clinic experience. Am J Surg. 2008 Oct;196(4):470-6. doi: 10.1016/j.amjsurg.2008.06.005. Epub 2008 Aug 23.
Hruska CB, O'Connor MK. Quantification of lesion size, depth, and uptake using a dual-head molecular breast imaging system. Med Phys. 2008 Apr;35(4):1365-76. doi: 10.1118/1.2885371.
Other Identifiers
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TASMC-09-EE-0192-CTIL
Identifier Type: -
Identifier Source: org_study_id
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