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Sponsored by: |
Mayo Clinic |
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Information provided by: | Mayo Clinic |
ClinicalTrials.gov Identifier: | NCT00620087 |
We aim to determine if Molecular Breast Imaging (a new nuclear medicine technique developed at Mayo) can identify malignant breast lesions in women who have atypical ductal hyperplasia, atypical lobular hyperplasia, or lobular carcinoma in situ.
Condition | Intervention |
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Atypical Lobular Hyperplasia Atypical Ductal Hyperplasia Lobular Carcinoma in Situ |
Device: Molecular Breast Imaging |
Study Type: | Interventional |
Study Design: | Diagnostic, Single Blind (Investigator), Uncontrolled, Parallel Assignment |
Official Title: | Evaluation of a Small Field of View Gamma Camera for Scintimammography in Patients With Atypical Ductal Hyperplasia, Atypical Lobular Hyperplasia, and Lobular Carcinoma In Situ |
Estimated Enrollment: | 100 |
Study Start Date: | August 2003 |
Estimated Study Completion Date: | December 2009 |
Estimated Primary Completion Date: | December 2009 (Final data collection date for primary outcome measure) |
Arms | Assigned Interventions |
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1
Diagnostic Arm
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Device: Molecular Breast Imaging
Molecular breast Imaging is a new nuclear medicine technique for imaging the breast. It uses small filed of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.
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2
Surveillance arm
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Device: Molecular Breast Imaging
Molecular breast Imaging is a new nuclear medicine technique for imaging the breast. It uses small filed of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.
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Management of atypical ductal hyperplasia (ADH), atypical lobular hyperplasia (ALH), and lobular carcinoma in situ (LCIS) diagnosed by breast needle core needle biopsy is controversial. Current practice is to recommend excisional biopsy to rule out malignant lesions, which have been reported in more than half of cases in some series. No consistent clinical, pathologic, or radiologic factors have been identified to select patients who do not require surgical excision. This is due, in part, to overlap in the mammographic features of benign and malignant lesions. Furthermore, reliance on mammography for surveillance of these high-risk patients is problematic. This highlights the need for a complementary imaging modality to improve the radiologic distinction between benign and malignant tumors and improve post-biopsy surveillance.
We are evaluating a new semiconductor-based gamma camera which we call Molecular Breast Imaging (MBI) which improves resolution by a factor of 2-3 compared to conventional gamma cameras, and, unlike mammography, is not affected by breast density. Preliminary clinical studies (IRB 0-1761-01)) have shown that scintimammography (SM) using Tc-99m sestamibi and the CZT camera (CZT-SM) has a high sensitivity and specificity for the evaluation of small (5-10 mm) lesions seen on mammography. We hypothesize that the MBI will reliably distinguish lesions that require excisional biopsy from lesions that do not. A secondary aim is to compare the role of MBI with mammography in post-biopsy surveillance.
We aim to enroll 50 Mayo patients who have received a diagnosis of ADH, ALH, or LCIS on core biopsy, who have not yet undergone excisional biopsy, and who consent to undergo MBI of both breasts. For images in which there is discordance with mammographic findings, ultrasound will be used to determine if additional abnormalities warrant excision. Using pathologic correlation, we will determine: 1) If residual foci of ADH, ALH, and LCIS are visible on MBI images; and 2) If MBI images can reliably predict contiguous or separate foci of malignant lesions in either breast.
We aim to complete this study in six years. In a separate but parallel study, those patients in whom no malignant lesion is identified will be offered annual MBI surveillance in addition to mammography for 5 years (the period of highest risk for development of malignancy). An additional cohort of 50 patients who have a history of ADH, ALH, or LCIS on a biopsy done within the past 5 years will be offered annual MBI surveillance. MBI and mammography will be compared as surveillance tools to detect malignant lesions.
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria for Surveillance Arm:
Inclusion Criteria for Diagnostic Arm:
Exclusion Criteria:
Subjects will be excluded if:
Responsible Party: | Mayo Clinic ( Deborah J. Rhodes, M.D. ) |
Study ID Numbers: | 1204-03 |
Study First Received: | December 26, 2007 |
Last Updated: | February 20, 2008 |
ClinicalTrials.gov Identifier: | NCT00620087 History of Changes |
Health Authority: | United States: Institutional Review Board |
Atypical lobular hyperplasia Atypical ductal hyperplasia Lobular carcinoma in situ Molecular Breast Imaging |
Carcinoma, Lobular Hyperplasia Carcinoma in Situ Zinc |
Iodine Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |
Carcinoma, Lobular Neoplasms Hyperplasia Pathologic Processes Neoplasms by Histologic Type |
Carcinoma in Situ Neoplasms, Ductal, Lobular, and Medullary Adenocarcinoma Neoplasms, Glandular and Epithelial Carcinoma |