Pilot Study: Combined Molecular Breast Imaging/Ultrasound System for Diagnostic Evaluation of MBI-detected Lesions
MBI/US
1 other identifier
interventional
12
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable breast-cancer
Started Sep 2012
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
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
September 1, 2012
CompletedFirst Submitted
Initial submission to the registry
March 1, 2013
CompletedFirst Posted
Study publicly available on registry
March 7, 2013
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 31, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedJuly 3, 2023
June 1, 2023
4.7 years
March 1, 2013
June 29, 2023
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
To evaluate the potential benefits of co-registered MBI and ultrasonic information relative to independent acquisition of each modality.
Presence / absence of correlation between lesion seen on ultrasound and lesion seen on MBI.
1 year
Study Arms (1)
Women with lesion on MBI
EXPERIMENTALWomen with lesion on MBI
Interventions
Molecular breast Imaging is a new nuclear medicine technique for imaging the breast. It uses small filed of view semiconductor-based gamma cameras that use Cadmium Zinc Telluride detectors. These have superior spatial and energy resolution to conventional sodium iodide detectors.
Eligibility Criteria
You may qualify if:
- 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.
- Have a finding of a mass lesion on ultrasound (BIRADS 0, 4 or 5) that is \> 0.5 cm and \< 2 cm in size.
- Have a positive finding on MBI that is \< 2 cm in size and requires additional diagnostic workup with focused ultrasound.
You may not qualify if:
- Are unable to understand and sign the consent form
- Are pregnant or lactating
- Are physically unable to sit upright and still for 40 minutes
- Have undergone bilateral mastectomy
- Are not scheduled to undergo conventional ultrasound
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Mayo Cliniclead
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: 21045179RESULT
Related Links
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Michael K O'Connor, PhD, R-D
Mayo Clinic
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 1, 2013
First Posted
March 7, 2013
Study Start
September 1, 2012
Primary Completion
May 31, 2017
Study Completion
June 1, 2017
Last Updated
July 3, 2023
Record last verified: 2023-06