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Image Quality Assessment for Screening and Diagnostic Mammography

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02786004
Recruitment Status : Completed
First Posted : May 30, 2016
Results First Posted : July 21, 2017
Last Update Posted : November 7, 2018
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Study Description
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Brief Summary:
This study is being conducted to determine the image quality of images using a new investigational medical imaging device.

Condition or disease Intervention/treatment Phase
Breast Health Device: Full Field Digital Mammography Device: Digital Breast Tomosynthesis Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 24 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Mammography Image Quality Assessment Reading NextGen Images for Screening and Diagnostic Use (MAGNIFI)
Study Start Date : February 2016
Actual Primary Completion Date : May 2016
Actual Study Completion Date : May 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Mammography

Arms and Interventions
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Arm Intervention/treatment
Experimental: Full Field Digital Mammography
2-dimensional breast imaging
 Device: Full Field Digital Mammography
Other Name: 2D Mammography
Experimental: Digital Breast Tomosynthesis
3-dimensional breast imaging
 Device: Digital Breast Tomosynthesis
Other Name: DBT


Outcome Measures
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Primary Outcome Measures :
  1. Number of Participants With Acceptable Overall Clinical Image Quality [ Time Frame: At enrollment completion approximately 3 months post initiation ]
    Overall clinical image quality was assessed by Mammography Quality Standards Act (MQSA) qualified radiologists ("readers"). Readers documented acceptability of FFDM and DBT image quality and image characteristics, as set for in the Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full Field Digital Mammography System (2012).


Secondary Outcome Measures :
  1. Number of Subjects Experiencing a Device Related Adverse Events, Serious Adverse Event, Unanticipated Device Effect, and Device Defects by Overall Occurrence. [ Time Frame: Through study completion, approximately 3 months ]
    Safety-related endpoint data (adverse events, serious adverse event, unanticipated device effect, and device defects) were monitored from all subjects for the duration of their participation. Results were summarized by cohort.


Eligibility Criteria
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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Are women aged 40 years or older (≥40 years old);
  2. Have had a FFDM (Full Field Digital Mammography) or DBT (Digital Breast Tomosynthesis) breast imaging exam within 30 days prior to enrollment;
  3. Have breast sizes compatible with the dimensions of a 24x29 cm image detector without anatomical cut-off;
  4. Are able to walk without assistive devices;
  5. Are sterile; post-menopausal; or if of childbearing potential, have a negative pregnancy test or is willing to provide urine sample to confirm no pregnancy, within 30 days of imaging exam; and
  6. Are willing to provide written informed consent to participate.

Exclusion Criteria:

  1. Have been previously included in this study or are participating in another trial expected to interfere with study procedures or outcomes;
  2. Have a history of breast biopsy, lumpectomy or mastectomy, or reconstruction on either breast;
  3. Are currently lactating;
  4. Are currently undergoing radiotherapy or chemotherapy , or have a history of prior radiotherapy treatment on either breast; or
  5. If enrolled to the DBT (Digital Breast Tomosynthesis) cohort, have breast implants (breast implants are not exclusionary in the FFDM (Full Field Digital Mammography) cohort).
Contacts and Locations
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Information from the National Library of Medicine

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): NCT02786004


Locations
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United States, North Carolina
Carolina Breast Imaging Specialist
Greenville, North Carolina, United States, 27834
Sponsors and Collaborators
GE Healthcare
Investigators
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Principal Investigator: Bruce Schroeder, MD Carolina Breast Imaging Specialists
More Information
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Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT02786004    
Other Study ID Numbers: 124.03-2015-GES-0004
First Posted: May 30, 2016    Key Record Dates
Results First Posted: July 21, 2017
Last Update Posted: November 7, 2018
Last Verified: October 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No