Biopsy, Breast Cancer Detection, Breast Neoplasm, Dense Breasts, Molecular Imaging
Conditions
Keywords
screening, crossover, single-group, pilot, biopsy, randomized assignment, dense breasts, MBI, molecular imaging
Brief summary
The goal of this pilot clinical trial is to demonstrate supplemental screening MBI (molecular breast imaging) in women with dense breasts. The main questions it aims to answer are: * 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
Detailed description
This is a pilot single-group crossover screening clinical trial comparing screening MBI (molecular breast imaging) to screening DBT (3D mammography, digital breast tomosynthesis. Women who have recently completed their annual screening DBT will be assessed for breast density. If they have BI-RADS density C or D (dense breasts), they are eligible for this study. After consent, participants will receive a supplemental screening MBI (crossover from DBT). Both screenings will be read while blinded to knowledge of the other. After independent reporting, a Conciliation Conference will compare the two, and a consensus report will be prepared. 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.
Interventions
DEVICEMolecular 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.
DEVICEMBI-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.
Sponsors
University of Texas, Southwestern Medical Center at Dallas
National Cancer Institute (NCI)
Smart Breast Corp.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
SCREENING
Masking
NONE
Masking description
After MBI-guided biopsy samples are placed sequentially in a Petri dish, an MBI image of the samples is taken. This image will be compared to the pathology report for concordance. The Outcomes Assessor will be blinded to patient ID and medical records. Similarly, the pathology report and screening DBT images will be compared.
Intervention model description
Every participant (dense breast woman) will receive both screening DBT and screening MBI (crossover). If biopsy is required, participant will be randomly assigned to either DBT-guided or MBI-guided biopsy.
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* dense breasts (BI-RADS C or D) on screening DBT
Exclusion criteria
* pregnancy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cancer Detection Rate | less than one day | The number of cancers found by a particular modality compared to the number of women with dense breasts screened by that modality. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Concordance Rate | less than a day | MBI-guided biopsies include an MBI image of the biopsy tissue samples in a Petri dish. Comparison of that image with the pathology report yields concordance. |
| Biopsy Call-Back Rate | less than a day | The percentage of women with dense breasts screened by a particular modality who have a suspicious lesion on their screening and they require biopsy. |
| Duration of Biopsy | less than a day | The amount of time that the modality-guided biopsy took to complete. |
Countries
United States
Contacts
Primary ContactJames W Hugg, PhD
Backup ContactBradley E Patt, PhD
Outcome results
None listed