Low Dose Molecular Breast Imaging as a Screening Tool for Women With Dense Breasts
Evaluation of Low-dose Molecular Breast Imaging as a Screening Tool in Women With Mammographically Dense Breasts and Increased Risk of Breast Cancer
1 other identifier
interventional
1,638
1 country
1
Brief Summary
A new test for breast cancer screening, molecular breast imaging (MBI) may be more sensitive than mammography for detecting breast cancer in women with dense breasts. The purpose of this study is to see if MBI using a low dose of gamma radiation can find cancers not seen on mammography. Hypotheses: 1. Low-Dose MBI has a significantly higher sensitivity and specificity and equal or higher positive predictive value than SM in women age 40 and older with mammographically dense breasts. 2. Low-dose MBI has comparable sensitivity and specificity to that previously achieved with MBI using a higher dose of radiation. 3. MBI produces a low false positive rate (specificity \>90%) that permits its use as a screening tool in this patient population.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable breast-cancer
Started Apr 2009
Typical duration for not_applicable breast-cancer
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 1, 2009
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2013
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2013
CompletedFirst Submitted
Initial submission to the registry
August 15, 2013
CompletedFirst Posted
Study publicly available on registry
August 19, 2013
CompletedResults Posted
Study results publicly available
August 19, 2014
CompletedAugust 19, 2014
July 1, 2014
4.2 years
August 15, 2013
May 29, 2014
July 30, 2014
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Cancer Detection Rate Per 1000 Women Screened, by Breast Density
The cancer detection rate per 1000 women screened is the estimate of the number of women with positive results from a screening test.
Within 21 days of mammography
Secondary Outcomes (4)
Specificity
Within 21 days of mammography
Sensitivity for All Cancers Diagnosed
Within 21 days of mammography
Recall Rate
12 months after mammography and MBI
Biopsy Rate
12 months after mammography and MBI
Study Arms (1)
Mammography and Molecular Breast Imaging
EXPERIMENTALParticipants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (8-mCi) Technetium (99mTc) sestamibi injection.
Interventions
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 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.
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.
Eligibility Criteria
You may qualify if:
- Past prior SM interpreted as negative or benign \[Breast Imaging Reporting and Data System (BI-RADS) Category 1 or 2\]
- Past prior SM interpreted as heterogeneously dense or extremely dense
You may not qualify if:
- Subject is unable to understand and sign the consent form
- Subject is pregnant or lactating
- Subject is physically unable to sit upright and still for 40 minutes
- Subject has self-reported signs or symptoms of breast cancer (palpable mass, bloody nipple discharge, axillary mass, etc.)
- Subject has had needle biopsy within 3 months, or breast surgery within 1 year prior to the study
- Subject is currently taking tamoxifen, Evista (raloxifene), Zoladex or an aromatase inhibitor for adjuvant therapy or chemoprevention.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
- Susan G. Komen Breast Cancer Foundationcollaborator
Study Sites (1)
Mayo Clinic
Rochester, Minnesota, 55905, United States
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: 21045179BACKGROUND
Related Links
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Results Point of Contact
- Title
- Dr. Deborah Rhodes
- Organization
- Mayo Clinic
Study Officials
- PRINCIPAL INVESTIGATOR
Deborah J Rhodes, M.D.
Mayo Clinic
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
- Associate Professor of Medicine
Study Record Dates
First Submitted
August 15, 2013
First Posted
August 19, 2013
Study Start
April 1, 2009
Primary Completion
June 1, 2013
Study Completion
June 1, 2013
Last Updated
August 19, 2014
Results First Posted
August 19, 2014
Record last verified: 2014-07