Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (ADAPT-ENRICH)
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|ClinicalTrials.gov Identifier: NCT02540083|
Recruitment Status : Terminated (Sponsor has obtained sufficient case load prematurely.)
First Posted : September 3, 2015
Results First Posted : February 5, 2019
Last Update Posted : February 5, 2019
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer Tumors, Breast||Device: DBT and FFDM||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||94 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography ADAPT-Enrich: Recruitment Plan for Initially Asymptomatic Women Referred for Breast Biopsy After Screening Digital Breast Tomosynthesis Exam|
|Actual Study Start Date :||August 2015|
|Actual Primary Completion Date :||May 30, 2017|
|Actual Study Completion Date :||May 30, 2017|
Experimental: Experimental: DBT and FFDM
Subjects underwent 2D breast imaging with full-field digital mammography (FFDM) followed by 3D breast imaging with digital breast tomosynthesis (DBT).
Device: DBT and FFDM
Subjects underwent FFDM breast imaging followed by DBT breast imaging
- Number of Participants With DBT, FFDM and Biopsy Specimens Collected [ Time Frame: Approximately 8 weeks ]For each participant, obtain image data using two methods (DBT and FFDM) and obtain histology results of biopsy specimens from women referred for biopsy.
- Lesion Type Observed by FFDM Imaging [ Time Frame: Approximately 8 weeks ]Lesions were characterized based on findings identified during image evaluations performed by qualified readers.
- Lesion Type Observed by DBT Imaging [ Time Frame: Approximately 8 weeks ]Lesions were characterized based on findings identified during image evaluations performed by qualified researchers.
- Lesion Size as Observed by FFDM [ Time Frame: Approximately 8 weeks ]Length of Lesions (measured in mm) when images were collected using FFDM.
- Lesion Size as Observed by DBT [ Time Frame: Approximately 8 weeks ]Length of lesions (measured in mm) when images were collected using DBT.
- Biopsy Finding of Lesions [ Time Frame: Approximately 8 weeks ]Describes histologic cancer and non-cancer findings of lesion biopsy.
- Safety - Device Related Malfunctions [ Time Frame: Approximately 8 weeks ]Number of device-related malfunctions by imaging modality.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02540083
|United States, North Carolina|
|Carolina Breast Imaging Specialists|
|Greenville, North Carolina, United States, 27834|
|United States, South Dakota|
|Avera Breast Center|
|Sioux Falls, South Dakota, United States, 57105|