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Automated Breast Ultrasound as an Adjunct to Screening Digital Breast Tomosynthesis (AMELIA)

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ClinicalTrials.gov Identifier: NCT03616457
Recruitment Status : Withdrawn (Change in business need.)
First Posted : August 6, 2018
Last Update Posted : October 26, 2018
Sponsor:
Information provided by (Responsible Party):
GE Healthcare

Brief Summary:
The purpose of this study is to assess whether the Invenia™ Automated Breast Ultrasound (ABUS) device, as an adjunct to Digital Breast Tomosynthesis (DBT), improves breast cancer detection in women with dense breasts. The study aims to collect information about cancer detection, treatment, and outcomes based on individual and combined technologies in patients who receive ABUS exams in addition to DBT. The results of this study are intended to be used to extend understanding of ABUS as an adjunct in DBT screening in patients with dense breasts.

Condition or disease Intervention/treatment
Breast Cancer Device: Automated Breast Ultrasound (ABUS)

Detailed Description:

Following consenting procedures, subjects will undergo standard of care DBT of both breasts or of one breast if they have had prior uni-lateral mastectomy. Subjects will also undergo ABUS of both breasts or of one breast if they have had prior uni-lateral mastectomy. These imaging exams will be done per the sites routine practice, and can be done in any order.

Images will be read and assessed by one (1) Mammography Quality Standards Act (MQSA)-qualified reader. The evaluating radiologist will use the image reconstruction views appropriate for the evaluation, per his or her medical judgment, and handle diagnostic evaluations in accordance with the standard of care at the investigational site. The DBT images will be read and assessed first and independent of ABUS images. DBT plus ABUS will then be read per routine practice and assessed. Images will not be read until both imaging exams have been completed.

If screening shows a suspicious finding, subjects will receive standard of care follow-up and appropriate workup, which may include biopsy (as needed), to determine cancer status. Subjects will be followed at approximately one year (11- to 16-months) unless negative histopathology with image concordance or positive cancer status is histologically determined prior to one-year follow-up. Follow up procedures will be conducted as per the sites standard of care.


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Study Type : Observational
Actual Enrollment : 0 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Evaluation of Automated Breast Ultrasound as an Adjunct to Screening Digital Breast Tomosynthesis in Women With Dense Breasts (AMELIA)
Estimated Study Start Date : August 2018
Estimated Primary Completion Date : August 2021
Estimated Study Completion Date : August 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Ultrasound

Group/Cohort Intervention/treatment
All Study Participants
All study participants will undergo the same study procedures, including Automated Breast Ultrasound (ABUS).
Device: Automated Breast Ultrasound (ABUS)
Participants will undergo imaging with ABUS.




Primary Outcome Measures :
  1. Cancer Detection Rate [ Time Frame: up to 16 months ]
    Cancer detection rate of DBT plus ABUS and DBT alone


Secondary Outcome Measures :
  1. Invasive Cancer Detection [ Time Frame: up to 16 months ]
    To demonstrate DBT plus ABUS has non-inferior invasive cancer detection relative to DBT alone in women with dense breasts

  2. Positive Predictive Value [ Time Frame: up to 16 months ]
    To demonstrate DBT plus ABUS has non-inferior positive predictive value (PPV 1) for breast cancer relative to DBT alone in women with dense breasts.

  3. Recall Rates [ Time Frame: up to 16 months ]
    To summarize recall rate of DBT plus ABUS in relation to the recall rate of DBT alone for breast cancer screening in dense breasts.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
This study will enroll asymptomatic adults who are clinically referred for breast cancer screening. Participants in this study will be representative of the clinical population.
Criteria

Inclusion Criteria:

  1. Are asymptomatic adult women (aged 40 years or older);
  2. Are presenting for a DBT breast cancer screening exam;
  3. Have heterogeneously dense or extremely dense breasts (BI-RADS C or D)
  4. Are able and willing to participate.

Exclusion Criteria:

  1. Have been previously included in this study;
  2. Have undergone diagnostic or surgical intervention in the last 12 months, including, but not limited to, core or open biopsy, clip placement, fine-needle aspiration, cytopunction, breast reduction or reconstruction, implant removals; OR
  3. Have had a breast cancer diagnosis or treatment in the past 12 months and have re-entered the screening population.

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): NCT03616457


Sponsors and Collaborators
GE Healthcare
Investigators
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Principal Investigator: Georgia Spear NorthShore University HealthSystem

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Responsible Party: GE Healthcare
ClinicalTrials.gov Identifier: NCT03616457     History of Changes
Other Study ID Numbers: 110.01-2018-GES-0001
First Posted: August 6, 2018    Key Record Dates
Last Update Posted: October 26, 2018
Last Verified: October 2018

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: Yes
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No
Keywords provided by GE Healthcare:
Screening Diagnostic