Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
250 participants
INTERVENTIONAL
2027-06-30
2028-06-30
Brief Summary
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* Does screening MBI find more cancer than screening DBT (3D mammography, digital breast tomosynthesis?
* Does screening MBI result in more call-backs for biopsy than DBT?
* How well does MBI-guided biopsy conform with pathology reports?
Researchers will compare screening MBI to screening DBT to see if MBI is more sensitive to detecting cancer in women with dense breasts.
Participants will
* Receive both screening DBT and screening MBI
* Receive either DBT-guided or MBI-guided biopsy (randomly assigned), if required by the screening images
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Detailed Description
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If biopsy is required on the consensus basis of both image sets, then the participant will be randomly assigned to DBT-guided or MBI-guided biopsy. If only one modality has visible lesions that require biopsy, then that modality will be assigned.
The primary outcome measure is Cancer Detection Rate. Secondary outcome measures include Biopsy Callback Rate, Concordance Rate between MBI biopsy sample images and pathology, Time Duration of Biopsy, and Accuracy of Lesion Targeting.
Conditions
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Study Design
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NA
SINGLE_GROUP
SCREENING
NONE
Study Groups
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Breast screening
Screening DBT and screening MBI are compared in women with dense breasts. Then, DBT-guided biopsy and MBI-guided biopsy are compared.
Molecular Breast Imaging
MBI is a molecular imaging (nuclear medicine) technique using a low dose i.v. radiopharmaceutical injection and solid-state gamma cameras to image the breast, where cancer mitochondria avidly take up the radiopharmaceutical.
MBI-guided biopsy
Two stereotactic MBI views of the breast produce a precise 3D location for each lesion targeted for biopsy. A vacuum-assisted core biopsy needle is guided to the lesion position.
Interventions
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Molecular Breast Imaging
MBI is a molecular imaging (nuclear medicine) technique using a low dose i.v. radiopharmaceutical injection and solid-state gamma cameras to image the breast, where cancer mitochondria avidly take up the radiopharmaceutical.
MBI-guided biopsy
Two stereotactic MBI views of the breast produce a precise 3D location for each lesion targeted for biopsy. A vacuum-assisted core biopsy needle is guided to the lesion position.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
Exclusion Criteria
21 Years
FEMALE
No
Sponsors
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University of Texas, Southwestern Medical Center at Dallas
OTHER
National Cancer Institute (NCI)
NIH
Smart Breast Corp.
INDUSTRY
Responsible Party
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Principal Investigators
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James W Hugg, PhD
Role: PRINCIPAL_INVESTIGATOR
Smart Breast Corp.
Locations
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University of Texas Southwestern Medical Center
Dallas, Texas, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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MBI_Biopsy_Pilot_SBIR
Identifier Type: -
Identifier Source: org_study_id
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