An interventional study of Molecular Breast Imaging and Screening Mammography in Atypical Lobular Hyperplasia, Atypical Ductal Hyperplasia and Lobular Carcinoma in Situ, sponsored by Mayo Clinic. Completed at 1 site in United States. Open to female participants aged 18 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2016-10-10.
Sponsored by Mayo Clinic · Not applicable, Interventional, and Diagnostic
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.
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.
207 studies on the registry are indexed under Carcinoma, Intraductal, Noninfiltrating; 45 are open to participants now.
This study's enrollment of 66 is close to the median of 68 across 156 interventional studies indexed under Carcinoma, Intraductal, Noninfiltrating.
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Of its 450 completed or terminated interventional studies of FDA-regulated products, 318 (71%) have results posted.
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Inclusion Criteria for Surveillance Arm:
Inclusion Criteria for Diagnostic Arm:
Exclusion Criteria:
Women with core-biopsy proven atypia, LCIS, or radial scar who have not yet undergone surgical excision were enrolled in the diagnostic arm. A molecular breast imaging study will be obtained.
Procedure: Molecular Breast Imaging
Women with a diagnosis of ADH, ALH, or LCIS within the past 5 years were enrolled in the surveillance arm. A molecular breast imaging study was done at enrollment (Year 0) and repeated at Yer 2 and Year 4. Patients continued with routine screening mammography during this time period.
Procedure: Molecular Breast Imaging · Procedure: Screening Mammography
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.
A screening mammogram is used to look for signs of breast cancer in women who don't have any breast symptoms or problems. X-ray pictures of each breast are taken from 2 different angles.
Correlation between molecular breast imaging findings and surgical pathology
Time frame: five years
Plan to share: Undecided
This study is completed, as verified in Oct 2016. You cannot join it, but the record below documents what was studied.
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Carcinoma, Intraductal, Noninfiltrating →