Molecular Breast Imaging in Women With Atypia and LCIS

This study is enrolling participants by invitation only.
Sponsor:
Information provided by (Responsible Party):
Deborah Rhodes, Mayo Clinic
ClinicalTrials.gov Identifier:
NCT00620087
First received: December 26, 2007
Last updated: May 30, 2014
Last verified: May 2014
  Purpose

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
Atypical Lobular Hyperplasia
Atypical Ductal Hyperplasia
Lobular Carcinoma in Situ
Device: Molecular Breast Imaging

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single Blind (Investigator)
Primary Purpose: Diagnostic
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

Further study details as provided by Mayo Clinic:

Primary Outcome Measures:
  • Correlation between molecular breast imaging findings and surgical pathology [ Time Frame: five years ] [ Designated as safety issue: No ]

Estimated Enrollment: 100
Study Start Date: August 2003
Estimated Study Completion Date: December 2016
Estimated Primary Completion Date: December 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
1
Diagnostic Arm
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.
2
Surveillance arm
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.

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.

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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:

Subjects will be excluded if:

  • 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.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00620087

Locations
United States, Minnesota
Mayo Clinic
Rochester, Minnesota, United States
Sponsors and Collaborators
Mayo Clinic
Investigators
Principal Investigator: Deborah J. Rhodes, M.D. Mayo Clinic
  More Information

Additional Information:
No publications provided

Responsible Party: Deborah Rhodes, MD, Mayo Clinic
ClinicalTrials.gov Identifier: NCT00620087     History of Changes
Obsolete Identifiers: NCT00963014
Other Study ID Numbers: 1204-03
Study First Received: December 26, 2007
Last Updated: May 30, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Mayo Clinic:
Atypical lobular hyperplasia
Atypical ductal hyperplasia
Lobular carcinoma in situ
Molecular Breast Imaging

Additional relevant MeSH terms:
Carcinoma
Carcinoma in Situ
Carcinoma, Lobular
Hyperplasia
Adenocarcinoma
Neoplasms
Neoplasms by Histologic Type
Neoplasms, Ductal, Lobular, and Medullary
Neoplasms, Glandular and Epithelial
Pathologic Processes

ClinicalTrials.gov processed this record on October 22, 2014