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| Name | Class |
|---|---|
| University of Texas, Southwestern Medical Center at Dallas | OTHER |
| National Cancer Institute (NCI) | NIH |
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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:
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
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Breast screening | Active Comparator | Screening DBT and screening MBI are compared in women with dense breasts. Then, DBT-guided biopsy and MBI-guided biopsy are compared. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Molecular Breast Imaging | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Cancer Detection Rate | The number of cancers found by a particular modality compared to the number of women with dense breasts screened by that modality. | less than one day |
| Measure | Description | Time Frame |
|---|---|---|
| Concordance Rate | 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. | less than a day |
| Biopsy Call-Back Rate |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| James W Hugg, PhD | Contact | 724-584-3266 | James.Hugg@SmartBreast.com | |
| Bradley E Patt, PhD | Contact | 818-645-4081 | Brad.Patt@SmartBreast.com |
| Name | Affiliation | Role |
|---|---|---|
| James W Hugg, PhD | Smart Breast Corp. | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of Texas Southwestern Medical Center | Dallas | Texas | 75390 | United States |
We will reconsider at the end of data acquisition.
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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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.
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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.
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| MBI-guided biopsy | Device | 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. |
|
The percentage of women with dense breasts screened by a particular modality who have a suspicious lesion on their screening and they require biopsy.
| less than a day |
| Duration of Biopsy | The amount of time that the modality-guided biopsy took to complete. | less than a day |
| D017437 |
| Skin and Connective Tissue Diseases |