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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00620373
• Other study ID #: 1337-05 Part A
• Secondary ID: Susan G. Komen F
• Status: Completed
• Phase: N/A
• First received: December 21, 2007
• Last updated: July 30, 2014
• Start date: August 2005
• Est. completion date: June 2010

Study information

• Verified date: July 2014
• Source: Mayo Clinic
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 969
• Est. completion date: June 2010
• Est. primary completion date: June 2010
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years and older

Eligibility

Inclusion Criteria:

1. Past prior screening mammography (SM) interpreted as negative or benign (This screening must have been performed at Mayo Clinic Rochester, Minnesota).

2. Past prior SM interpreted as heterogeneously dense or extremely dense (This screening must have been performed at Mayo Clinic Rochester, Minnesota).

3. Women younger than 50 years who had not undergone prior mammography, as most of these women have dense breasts.

4. 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:

1. They are unable to understand and sign the consent form

2. They are pregnant or lactating

3. They are physically unable to sit upright and still for 40 minutes.

4. They have self-reported signs or symptoms of breast cancer (palpable mass, bloody nipple discharge, axillary mass etc.).

5. They have had needle biopsy within 3 months, or breast surgery within 1 year prior to the study.

6. They are currently taking tamoxifen, evista (raloxifene), or an aromatase inhibitor for adjuvant therapy or chemoprevention.

Study Design

Intervention Model: Single Group Assignment, Masking: Single Blind (Investigator), Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• Molecular Breast Imaging
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.
• Conventional Mammography
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.

Drug:
• Technetium (99mTc) sestamibi
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.

Locations

Country	Name	City	State
United States	Mayo Clinic	Rochester	Minnesota

Sponsors (2)

Lead Sponsor	Collaborator
Mayo Clinic	Susan G. Komen Breast Cancer Foundation

Country where clinical trial is conducted

United States, 

References & Publications (1)

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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).	12 months after mammography and gamma imaging	No
Primary	Number of Participants With Cancer Diagnosis at 12 Months		12 months after mammography and gamma imaging	No
Secondary	Sensitivity	Sensitivity measures the proportion of actual positives which are correctly identified as such.	12 months after mammography and gamma imaging	No
Secondary	Specificity	Specificity measures the proportion of negatives which are correctly identified as such.	12 month after mammography and gamma imaging	No
Secondary	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.	12 months after mammography and gamma imaging	No

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