Clinical trial · Interventional
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
NCT00620373CI-TRIAL-00015288completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Conventional Mammography | Device | — | UNRESOLVED |
| Molecular Breast Imaging | Device | — | UNRESOLVED |
| Technetium (99mTc) sestamibi | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Mammography and Molecular Breast Imaging
- description
- Participants underwent conventional mammography and molecular breast imaging after a 740-millibecquerel (mBQ) (20-mCi) Technetium (99mTc) sestamibi injection.
- interventionNames
- Device: Molecular Breast Imaging
- Device: Conventional Mammography
- Drug: Technetium (99mTc) sestamibi
Primary outcomes (2)
- measure
- Diagnostic Yield
- timeFrame
- 12 months after mammography and gamma imaging
- description
- 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).
- measure
- Number of Participants With Cancer Diagnosis at 12 Months
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 25 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTRhodes 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