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Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts

Primary Purpose

Breast Cancer

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Molecular Breast Imaging

Conventional Mammography

Technetium (99mTc) sestamibi

About this trial

This is an interventional diagnostic trial for Breast Cancer focused on measuring Dense breast tissue, Breast Cancer Screening, Molecular Breast Imaging, Breast Cancer, Breast

Eligibility Criteria

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

Inclusion Criteria:

Past prior screening mammography (SM) interpreted as negative or benign (This screening must have been performed at Mayo Clinic Rochester, Minnesota).
Past prior SM interpreted as heterogeneously dense or extremely dense (This screening must have been performed at Mayo Clinic Rochester, Minnesota).
Women younger than 50 years who had not undergone prior mammography, as most of these women have dense breasts.
Subjects had to have at least one of the following risk factors:
1. Known mutation in breast cancer susceptibility gene 1 (BRCA1) or breast cancer susceptibility gene 2 (BRCA2)
2. History of chest, mediastinal, or axillary irradiation
3. Personal history of breast cancer
4. History of prior biopsy showing atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in situ, or atypical papilloma
5. Gail or Claus model lifetime risk greater than or equal to 20%
6. Gail model 5 year risk greater or equal to 2.5%
7. Gail model 5 year risk greater or equal to 1.6%
8. One first-degree relative with history of breast cancer
9. Two second-degree relatives with history of breast cancer

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 have self-reported signs or symptoms of breast cancer (palpable mass, bloody nipple discharge, axillary mass etc.).
They have had needle biopsy within 3 months, or breast surgery within 1 year prior to the study.
They are currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor for adjuvant therapy or chemoprevention.

Sites / Locations

Mayo Clinic

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Mammography and Molecular Breast Imaging

Arm Description

Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (20-mCi) Technetium (99mTc) sestamibi injection.

Outcomes

Primary Outcome Measures

Diagnostic Yield

Diagnostic yield is the likelihood that a test or procedure will provide the information needed to establish a diagnosis. In this case, it is the proportion of women with positive results of a screening test and positive results with the reference standard (verified cancer status).

Number of Participants With Cancer Diagnosis at 12 Months

Secondary Outcome Measures

Sensitivity

Sensitivity measures the proportion of actual positives which are correctly identified as such.

Specificity

Specificity measures the proportion of negatives which are correctly identified as such.

Recall Rate

Recall rate was defined as the percentage of participants recalled for follow-up studies initiated because of abnormal findings with mammography or gamma imaging.

Full Information

NCT ID

NCT00620373

First Posted

December 21, 2007

Last Updated

July 30, 2014

Sponsor

Mayo Clinic

Collaborators

Susan G. Komen Breast Cancer Foundation

1. Study Identification

Unique Protocol Identification Number

NCT00620373

Brief Title

Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts

Official Title

Evaluation of Low-dose Molecular Breast Imaging as a Screening Tool in Women With Mammographically Dense Breasts and Increased Risk of Breast Cancer

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

August 2005 (undefined)

Primary Completion Date

June 2010 (Actual)

Study Completion Date

June 2010 (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

5. Study Description

Brief Summary

We aim to compare the sensitivity of mammography to the sensitivity of Molecular Breast Imaging (a new gamma-camera based breast imaging technology) in women with dense breast tissue who are at increased risk for breast cancer.

Detailed Description

The sensitivity of conventional mammography (MMO) is poor in women with mammographically dense breast parenchyma. We have developed Molecular Breast Imaging (MBI) - a new technique which utilizes a Cadmium-Zinc-Telluride (CZT) gamma camera for scintimammography that has a high sensitivity (~90%) for the detection of breast cancers independent of breast density. The aim of this study is to demonstrate the utility of MBI as an adjunct screening modality for the detection of occult breast cancers in women with mammographically dense breast tissue. Initial recruitment will be from the pool of patients awaiting a screening mammogram in the Department of Radiology at Mayo Clinic Rochester. All patients will have a screening MMO and an MBI study. Patients with positive studies (MBI or MMO) will undergo additional diagnostic studies. At 15 months post-recruitment, all patients will be contacted by phone or mail to determine whether subsequent to their study, there has been any change in their breast status.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Breast Cancer

Keywords

Dense breast tissue, Breast Cancer Screening, Molecular Breast Imaging, Breast Cancer, Breast

7. Study Design

Primary Purpose

Diagnostic

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Masking

Investigator

Allocation

N/A

Enrollment

969 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Mammography and Molecular Breast Imaging

Arm Type

Experimental

Arm Description

Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (20-mCi) Technetium (99mTc) sestamibi injection.

Intervention Type

Device

Intervention Name(s)

Molecular Breast Imaging

Intervention Description

Molecular breast imaging is a new nuclear medicine technique for imaging the breast. It uses small field 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

Device

Intervention Name(s)

Conventional Mammography

Intervention Description

Mammography is the process of using low-energy X-rays (usually around 30 kVp) to examine the human breast and is used as a diagnostic and a screening tool.

Intervention Type

Drug

Intervention Name(s)

Technetium (99mTc) sestamibi

Other Intervention Name(s)

Cardiolite

Intervention Description

Technetium (99mTc) sestamibi is a pharmaceutical agent used in nuclear medicine imaging. The drug is a coordination complex consisting of the radioisotope technetium-99m bound to six methoxyisobutylisonitrile (MIBI) ligands.

Primary Outcome Measure Information:

Title

Diagnostic Yield

Description

Time Frame

12 months after mammography and gamma imaging

Title

Number of Participants With Cancer Diagnosis at 12 Months

Time Frame

12 months after mammography and gamma imaging

Secondary Outcome Measure Information:

Title

Sensitivity

Description

Sensitivity measures the proportion of actual positives which are correctly identified as such.

Time Frame

12 months after mammography and gamma imaging

Title

Specificity

Description

Specificity measures the proportion of negatives which are correctly identified as such.

Time Frame

12 month after mammography and gamma imaging

Title

Recall Rate

Description

Recall rate was defined as the percentage of participants recalled for follow-up studies initiated because of abnormal findings with mammography or gamma imaging.

Time Frame

12 months after mammography and gamma imaging

10. Eligibility

Sex

Female

Minimum Age & Unit of Time

25 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Past prior screening mammography (SM) interpreted as negative or benign (This screening must have been performed at Mayo Clinic Rochester, Minnesota). Past prior SM interpreted as heterogeneously dense or extremely dense (This screening must have been performed at Mayo Clinic Rochester, Minnesota). Women younger than 50 years who had not undergone prior mammography, as most of these women have dense breasts. Subjects had to have at least one of the following risk factors: Known mutation in breast cancer susceptibility gene 1 (BRCA1) or breast cancer susceptibility gene 2 (BRCA2) History of chest, mediastinal, or axillary irradiation Personal history of breast cancer History of prior biopsy showing atypical ductal hyperplasia, atypical lobular hyperplasia, lobular carcinoma in situ, or atypical papilloma Gail or Claus model lifetime risk greater than or equal to 20% Gail model 5 year risk greater or equal to 2.5% Gail model 5 year risk greater or equal to 1.6% One first-degree relative with history of breast cancer Two second-degree relatives with history of breast cancer 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 have self-reported signs or symptoms of breast cancer (palpable mass, bloody nipple discharge, axillary mass etc.). They have had needle biopsy within 3 months, or breast surgery within 1 year prior to the study. They are currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor for adjuvant therapy or chemoprevention.

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

Citations:

PubMed Identifier

21045179

Citation

Rhodes DJ, Hruska CB, Phillips SW, Whaley DH, O'Connor MK. Dedicated dual-head gamma imaging for breast cancer screening in women with mammographically dense breasts. Radiology. 2011 Jan;258(1):106-18. doi: 10.1148/radiol.10100625. Epub 2010 Nov 2.

Results Reference

result

Links:

URL

http://www.youtube.com/watch?v=DOQBLe8MdH0

Description

Mayo Clinic You Tube Channel

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Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts

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