Molecular Breast Imaging: A Novel Technology for Detection of Malignant Breast Lesions
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Purpose
Detection of breast cancer as early as possible is an ongoing imaging challenge.The purpose of the current study is to assess the clinical performance of the new scintigraphic technology, a dedicated breast gamma camera composed by the new generation of CZT detectors,for assessment of breast pathology specifically in women where current imaging techniques, mainly mammography are suboptimal. These cohort are patients with dense breast tissue and patients who are at high risk for breast cancer by a combination of other metrics, including family history and genetic testing. BRCA (breast cancer susceptibility gene), is particularly a relevant health problem among Ashkenazi Jews in Israel.
| Condition |
|---|
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Small Breast Lesions Dense Breast Tissue Discrepancy With Clinical Examination Equivocal Mammographic, Sonographic or MRI Lesion |
| Study Type: | Observational |
| Study Design: | Observational Model: Cohort Time Perspective: Prospective |
| Official Title: | Molecular Breast Imaging: A Novel Technology for Detection of Malignant Breast Lesions. |
- Detection of unexpected malignant lesions. Ruling out malignant lesions in case of equivocal lesions identified by clinical examination, mammography, US and/or MRI. [ Time Frame: 6 mounth post scintigraphy ] [ Designated as safety issue: No ]
| Estimated Enrollment: | 500 |
| Study Start Date: | October 2009 |
| Estimated Study Completion Date: | October 2015 |
| Estimated Primary Completion Date: | October 2014 (Final data collection date for primary outcome measure) |
| Groups/Cohorts |
|---|
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Women with equivocal findings on Mammography, US and/or MRI
Women with equivocal findings on Mammography, US and/or MRI
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Discrepancy between clinical examination and imaging
Women with discrepancy between clinical examination and breast imaging
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Women with dense breast
Women with dense breast
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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.
|
Detailed Description:
Recently, a breast-dedicated gamma camera has been used for assessment of breast malignancy in over 1000 women in Mayo Clinic, Rochester, USA. Molecular Breast Imaging (MBI), which utilizes a Cadmium-Zinc-Telluride (CZT) gamma camera for scintimammography, has been shown to have a high sensitivity (91%) for the detection of breast lesions > 5 mm in diameter and 69% for tumors smaller than 5mm.
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.
Eligibility| Ages Eligible for Study: | 25 Years and older |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
| Sampling Method: | Non-Probability Sample |
A wide COHORT from all over Israel , in which the referring physician and/or the breast-imaging physician will look for additional imaging modality. Women with equivocal findings on Mammography, US and/or MRI. Women with discrepancy between clinical examination and conventional breast imaging. Women with dense breast. Women with genetic and/or family history high risk for Breast Cancer
Inclusion Criteria:
- Age over 25.
- Equivocal breast lesions.
- Dense breast tissue.
- High-risk for breast cancer
Exclusion Criteria:
- Age under 25.
- Pregnancy.
- Patients unable to understand and sign an informed consent
Contacts and Locations| Contact: Einat Even-sapir, PhD, MD | 972-3-6974444 ext 3536 | evensap@tasmc.health.gov.il |
| Contact: Ayelet Kurzband, BA | 972-3-6974444 ext 3536 | ayeletk@tasmc.health.gov.il |
| Israel | |
| Department of Nuclear Medicine, Tel Aviv Sourasky Medical Center | Recruiting |
| Tel Aviv, Israel, 64239 | |
| Contact: Einat Even-Sapir, MD, PhD 972-3-6974444 ext 3536 evensap@tasmc.health.gov.il | |
| Contact: Ayelet Kurzband, BA 972-3-6974444 ext 3536 ayeletk@tasmc.health.gov.il | |
| Principal Investigator: Einat Even-Sapir, MD, PhD | |
| Sub-Investigator: Hedva Lerman, MD | |
| Principal Investigator: | Einat Even-Sapir, MD, PhD | Tel Aviv Sourasky Medical Center, Tel Aviv, Israel |
More Information
Publications:
| Responsible Party: | Tel-Aviv Sourasky Medical Center |
| ClinicalTrials.gov Identifier: | NCT01004666 History of Changes |
| Other Study ID Numbers: | TASMC-09-EE-0192-CTIL |
| Study First Received: | October 29, 2009 |
| Last Updated: | January 3, 2013 |
| Health Authority: | Israel: Ministry of Health. Israel: Clinical Trials and Devices. |
Keywords provided by Tel-Aviv Sourasky Medical Center:
|
Breast cancer Scintimammography CZT High-risk |
ClinicalTrials.gov processed this record on May 19, 2013