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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
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Tracking Information
First Submitted Date  ICMJE September 1, 2015
First Posted Date  ICMJE September 3, 2015
Results First Submitted Date  ICMJE January 4, 2019
Results First Posted Date  ICMJE February 5, 2019
Last Update Posted Date February 5, 2019
Actual Study Start Date  ICMJE August 2015
Actual Primary Completion Date May 30, 2017   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 1, 2019)
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.
Original Primary Outcome Measures  ICMJE
 (submitted: September 1, 2015)
Cancer Status (Sites' diagnosis of cancer status (positive/negative) [ Time Frame: less than 16 months ]
Sites' diagnosis of cancer status (positive/negative) for each subject based on histology
Change History Complete list of historical versions of study NCT02540083 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures  ICMJE
 (submitted: February 1, 2019)
  • 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.
Original Secondary Outcome Measures  ICMJE
 (submitted: September 1, 2015)
Cancer Characteristics (composite of cancer characteristics will be collected) [ Time Frame: less than 16 months ]
For subjects with positive cancer status, cancer characteristics including invasive/non-invasive, histology and size will be collected.
Current Other Pre-specified Outcome Measures
 (submitted: February 1, 2019)
Safety - Device Related Malfunctions [ Time Frame: Approximately 8 weeks ]
Number of device-related malfunctions by imaging modality.
Original Other Pre-specified Outcome Measures
 (submitted: September 1, 2015)
Safety (Device-related adverse events, serious adverse events and device malfunctions by overall occurrence and imaging modality) [ Time Frame: less than 16 months ]
Device-related adverse events, serious adverse events and device malfunctions by overall occurrence and imaging modality will be collected
 
Descriptive Information
Brief Title  ICMJE Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography
Official Title  ICMJE 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
Brief Summary The aim of this recruitment plan (ADAPT-Enrich) is to collect image and technical data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM), along with other subject data including histology results from biopsy specimen examination and cancer classification data from initially asymptomatic women referred for clinically indicated breast biopsy based on suspicious DBT screening breast imaging results. These data will be included in a subsequent and prospectively planned pooled analysis described in a separate protocol (ADAPT-BIE) examining superiority of DBT to FFDM for breast cancer diagnosis and other performance measures.
Detailed Description ADAPT-ENRICH will supplement an on-going program (ADAPT) which consists of 2 additional recruitment plans (ADAPT-SCR and ADAPT-BX) followed by an off-line read of the images and data collected (ADAPT-BIE). This study involves the comparison of two devices that can identify abnormalities in routine breast screening and diagnostic mammography. Mammography is usually done with full-field digital mammography (FFDM), which takes flat, two-dimensional X-ray images of the breast. Doctors use the two-dimensional images to look for cancers and other abnormal tissue. The purpose of this study is to learn more about the accuracy of full-field digital mammography devices and a new mammography device called digital breast tomosynthesis (DBT). DBT is similar to full-field digital mammography, but can also move around the breast to get X-ray images from different angles, which provides a three-dimensional view that doctors can use to look for cancers and abnormal tissue. Subjects will be recruited from an initially asymptomatic population that have been referred for clinically indicated breast biopsy based on suspicious DBT screening breast imaging results. Subjects will undergo a DBT mammogram prior to biopsy. If FFDM was not performed within 30 days, subjects will also undergo FFDM prior to biopsy. Results of biopsy(ies) and histopathology, including lesion characteristics, will be recorded and considered as truth if positive for cancer status. Subjects with negative or benign histological findings will be followed for approximately one year (10-16 months) by FFDM and any additional standard of care practice.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE
  • Breast Cancer
  • Tumors, Breast
Intervention  ICMJE Device: DBT and FFDM
Subjects underwent FFDM breast imaging followed by DBT breast imaging
Other Names:
  • Digital Breast Tomosynthesis (3D breast imaging) DBT
  • Full-Field Digital Mammography (2D breast imaging) FFDM
Study Arms  ICMJE 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).
Intervention: Device: DBT and FFDM
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Terminated
Actual Enrollment  ICMJE
 (submitted: February 22, 2017)
94
Original Estimated Enrollment  ICMJE
 (submitted: September 1, 2015)
200
Actual Study Completion Date  ICMJE May 30, 2017
Actual Primary Completion Date May 30, 2017   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women aged 30 years or older (≥30 years old);
  • Initially asymptomatic women who underwent routine bilateral screening with Digital Breast Tomosynthesis (DBT), followed by diagnostic work-up showing one or more abnormalities and referred for breast biopsy;
  • Are able and willing to comply with study procedures;
  • Have signed and dated the informed consent form;
  • Documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy.

Exclusion Criteria:

  • Have been previously included in this study , ADAPT-SCR recruitment plan or ADAPT-BX recruitment plan;
  • Have undergone diagnostic or surgical intervention(s) or procedure(s) on either breast, including mastectomy and cytopunction, before study-related imaging;
  • Have breasts too large to be adequately positioned on 24 x 31 centimeter (cm) DBT or FFDM digital receptor without anatomical cut-off during a DBT or FFDM examination;
  • Have participated in (within the prior 30 days) another trial of an investigational product expected to interfere with study procedures or outcomes;
  • Have breast implant(s);
  • Have reconstructed breast(s).
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Ages  ICMJE 30 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT02540083
Other Study ID Numbers  ICMJE 124.03-2015-GES-0001
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party GE Healthcare
Study Sponsor  ICMJE GE Healthcare
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account GE Healthcare
Verification Date February 2019

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP