Clinical trial · Interventional
Pilot Study: Combined Molecular Breast Imaging/Ultrasound System for Diagnostic Evaluation of MBI-detected Lesions
NCT01806558CI-TRIAL-00067702MBI/UScompletedN/AClinicalTrials.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)
A combined molecular breast imaging / ultrasound system will enable coregistration of a functional abnormality seen on Molecular Breast Imaging (MBI) with the corresponding anatomical abnormality seen on ultrasound.
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 (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Molecular Breast Imaging | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Women with lesion on MBI
- description
- Women with lesion on MBI
- interventionNames
- Procedure: Molecular Breast Imaging
Primary outcomes (1)
- measure
- To evaluate the potential benefits of co-registered MBI and ultrasonic information relative to independent acquisition of each modality.
- timeFrame
- 1 year
- description
- Presence / absence of correlation between lesion seen on ultrasound and lesion seen on MBI.
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 40 Years
Show eligibility criteria text
Inclusion Criteria: * The pilot study will comprise 12 women age 40 and older who have at least one of the following inclusion criteria: 1. Have a finding of a mass lesion on mammography or breast MRI (BIRADS 0, 4 or 5) that is \>0.5 cm and \< 2 cm in size and has had or will have additional workup with focused ultrasound. 2. Have a finding of a mass lesion on ultrasound (BIRADS 0, 4 or 5) that is \> 0.5 cm and \< 2 cm in size. 3. Have a positive finding on MBI that is \< 2 cm in size and requires additional diagnostic workup with focused ultrasound. Exclusion Criteria: 1. Are unable to understand and sign the consent form 2. Are pregnant or lactating 3. Are physically unable to sit upright and still for 40 minutes 4. Have undergone bilateral mastectomy 5. Are not scheduled to undergo conventional ultrasound
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