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

NCT00620373 | Completed Results

• 2 other identifiers: 1337-05 Part ASusan G. Komen Foundation
• Study Type: interventional
• Target: 969
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

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

Outcome Measures

Primary Outcomes (2)

• 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

• Number of Participants With Cancer Diagnosis at 12 Months

  12 months after mammography and gamma imaging

Secondary Outcomes (3)

• Sensitivity

  12 months after mammography and gamma imaging

• Specificity

  12 month after mammography and gamma imaging

• Recall Rate

  12 months after mammography and gamma imaging

Study Arms (1)

Mammography and Molecular Breast Imaging

EXPERIMENTAL

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

Device: Molecular Breast Imaging; Device: Conventional Mammography; Drug: Technetium (99mTc) sestamibi

Interventions

Molecular Breast Imaging DEVICE

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.

Mammography and Molecular Breast Imaging

Conventional Mammography DEVICE

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.

Mammography and Molecular Breast Imaging

Technetium (99mTc) sestamibi DRUG

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.

Also known as: Cardiolite

Mammography and Molecular Breast Imaging

Eligibility Criteria

• Age: 25 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify 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 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.

Sponsors & Collaborators

• Mayo Clinic: lead
• Susan G. Komen Breast Cancer Foundation: collaborator

Study Sites (1)

Mayo Clinic

Rochester, Minnesota, 55905, United States

Location

Related 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.

  PMID: 21045179 RESULT

Related Links

• Mayo Clinic You Tube Channel

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Technetium Tc 99m Sestamibi

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Organotechnetium Compounds; Organometallic Compounds

Results Point of Contact

• Title: Dr. Deborah J. Rhodes
• Organization: Mayo Clinic

rhodes.deborah@mayo.edu

507-538-1703

Study Officials

• Deborah J. Rhodes, M.D.

  Mayo Clinic

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: December 21, 2007
• First Posted: February 21, 2008
• Study Start: August 1, 2005
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: August 1, 2014
• Results First Posted: December 30, 2013

Record last verified: 2014-07

Locations

US (1)