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Molecular Breast Imaging in Women With Atypia and LCIS

Primary Purpose

Atypical Lobular Hyperplasia, Atypical Ductal Hyperplasia, Lobular Carcinoma in Situ

Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Molecular Breast Imaging
Screening Mammography
Sponsored by
Mayo Clinic
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Atypical Lobular Hyperplasia focused on measuring Atypical lobular hyperplasia, Atypical ductal hyperplasia, Lobular carcinoma in situ, Molecular Breast Imaging

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleAccepts Healthy Volunteers

Inclusion Criteria for Surveillance Arm:

  • Diagnosis of biopsy-prove ADH, ALH, or LCIS within the past 5 years based on core needle biopsy and/or excisional biopsy and confirmed by a Mayo pathologist.

Inclusion Criteria for Diagnostic Arm:

  • Recent core needle biopsy of the breast demonstrating ADH, ALH, or LCIS confirmed by Mayo pathologist.

Exclusion Criteria:

  • They are unable to understand and sign the consent form
  • They are pregnant or lactating
  • They are physically unable to sit upright and still for 40 minutes
  • They are younger than 18 years of age.

Sites / Locations

  • Mayo Clinic

Arms of the Study

Arm 1

Arm 2

Arm Type

Other

Other

Arm Label

Diagnostic Arm

Surveillance arm

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

Correlation between molecular breast imaging findings and surgical pathology

Secondary Outcome Measures

Full Information

First Posted
December 26, 2007
Last Updated
October 6, 2016
Sponsor
Mayo Clinic
Collaborators
Susan G. Komen Breast Cancer Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT00620087
Brief Title
Molecular Breast Imaging in Women With Atypia and LCIS
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
Study Type
Interventional

2. Study Status

Record Verification Date
October 2016
Overall Recruitment Status
Completed
Study Start Date
August 2003 (undefined)
Primary Completion Date
July 2015 (Actual)
Study Completion Date
July 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mayo Clinic
Collaborators
Susan G. Komen Breast Cancer Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
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.
Detailed Description
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Atypical Lobular Hyperplasia, Atypical Ductal Hyperplasia, Lobular Carcinoma in Situ
Keywords
Atypical lobular hyperplasia, Atypical ductal hyperplasia, Lobular carcinoma in situ, Molecular Breast Imaging

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Investigator
Allocation
Non-Randomized
Enrollment
66 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Diagnostic Arm
Arm Type
Other
Arm Description
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.
Arm Title
Surveillance arm
Arm Type
Other
Arm Description
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.
Intervention Type
Procedure
Intervention Name(s)
Molecular Breast Imaging
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Screening Mammography
Intervention Description
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.
Primary Outcome Measure Information:
Title
Correlation between molecular breast imaging findings and surgical pathology
Time Frame
five years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria for Surveillance Arm: Diagnosis of biopsy-prove ADH, ALH, or LCIS within the past 5 years based on core needle biopsy and/or excisional biopsy and confirmed by a Mayo pathologist. Inclusion Criteria for Diagnostic Arm: Recent core needle biopsy of the breast demonstrating ADH, ALH, or LCIS confirmed by Mayo pathologist. Exclusion Criteria: They are unable to understand and sign the consent form They are pregnant or lactating They are physically unable to sit upright and still for 40 minutes They are younger than 18 years of age.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Deborah J. Rhodes, M.D.
Organizational Affiliation
Mayo Clinic
Official's Role
Principal Investigator
Facility Information:
Facility Name
Mayo Clinic
City
Rochester
State/Province
Minnesota
ZIP/Postal Code
55905
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
25615744
Citation
Rhodes DJ, Hruska CB, Conners AL, Tortorelli CL, Maxwell RW, Jones KN, Toledano AY, O'Connor MK. Journal club: molecular breast imaging at reduced radiation dose for supplemental screening in mammographically dense breasts. AJR Am J Roentgenol. 2015 Feb;204(2):241-51. doi: 10.2214/AJR.14.13357.
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Molecular Breast Imaging in Women With Atypia and LCIS

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