Clinical trial · Interventional
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
- 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)
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.
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) (8-mCi) Technetium (99mTc) sestamibi injection.
- interventionNames
- Device: Molecular Breast Imaging
- Device: Conventional Mammography
- Drug: Technetium (99mTc) sestamibi
Primary outcomes (1)
- measure
- Cancer Detection Rate Per 1000 Women Screened, by Breast Density
- timeFrame
- Within 21 days of mammography
- description
- The cancer detection rate per 1000 women screened is the estimate of the number of women with positive results from a screening test.
Secondary outcomes (4)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * 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 Exclusion Criteria: * 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.
References
Publications (1)
- BACKGROUNDRhodes 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