Breast HealthNCT02786004

Image Quality Assessment for Screening and Diagnostic Mammography

A study testing Full Field Digital Mammography and Digital Breast Tomosynthesis in people with Breast Health, run by GE Healthcare at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial summary

This study is being conducted to determine the image quality of images using a new investigational medical imaging device. Read more about this study

Who is it for?: Ages 40 years and older
Conditions the study is for: Breast Health
What is being tested?: Full Field Digital Mammography and Digital Breast Tomosynthesis
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 24 participants
Where: 1 siteUnited States
Study dates: Feb 2016to May 2016
Phase: Interventional
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 40 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Are women aged 40 years or older (≥40 years old);
Have had a FFDM (Full Field Digital Mammography) or DBT (Digital Breast Tomosynthesis) breast imaging exam within 30 days prior to enrollment;
Have breast sizes compatible with the dimensions of a 24x29 cm image detector without anatomical cut-off;
Are able to walk without assistive devices;
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
Are willing to provide written informed consent to participate.

Who cannot join

Have been previously included in this study or are participating in another trial expected to interfere with study procedures or outcomes;
Have a history of breast biopsy, lumpectomy or mastectomy, or reconstruction on either breast;
Are currently lactating;
Are currently undergoing radiotherapy or chemotherapy , or have a history of prior radiotherapy treatment on either breast; or
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).

Trial locations and contacts

1 site in 1 country.

United States1 site

Carolina Breast Imaging Specialist
Greenville, North Carolina, 27834

Other trials in United States

About this study

Official title: Mammography Image Quality Assessment Reading NextGen Images for Screening and Diagnostic Use (MAGNIFI)

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

Conditions: Breast Health
Being tested: Full Field Digital Mammography, Digital Breast Tomosynthesis

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Full Field Digital MammographyDevice
Also called 2D Mammography
Digital Breast TomosynthesisDevice
Also called DBT

Study groups in NCT02786004
Study group	Role	What they receive
Full Field Digital Mammography	Experimental	2-dimensional breast imaging Receives: Device: Full Field Digital Mammography
Digital Breast Tomosynthesis	Experimental	3-dimensional breast imaging Receives: Device: Digital Breast Tomosynthesis

What is being measured

The primary outcome is the main question the study is designed to answer.

Number of Participants With Acceptable Overall Clinical Image Quality
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).
Measured: At enrollment completion approximately 3 months post initiation

Secondary outcomes (1)

Number of Subjects Experiencing a Device Related Adverse Events, Serious Adverse Event, Unanticipated Device Effect, and Device Defects by Overall Occurrence.
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.
Measured: Through study completion, approximately 3 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Feb 2016May 2016

First posted30 May 2016 (estimated)
Study startFeb 2016
Primary completionMay 2016
Study completionMay 2016

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Breast HealthStudies of the same condition, open and under way.
More trials run by GE HealthcareThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 24 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02786004
Sponsor's protocol ID: 124.03-2015-GES-0004
Status last verified: Oct 2018
First submitted: 24 May 2016
Last updated: 7 Nov 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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All Breast Health trials

Study at a glance

From the registry record, last updated by the sponsor on 7 Nov 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Mammography Image Quality Assessment Reading NextGen Images for Screening and Diagnostic Use (MAGNIFI)
ClinicalTrials.gov ID: NCT02786004
Acronym / sponsor ID: 124.03-2015-GES-0004
Conditions: Breast Health
Study type: Interventional
Recruitment status: Completed
Enrolment: 24 participants (actual)
Lead sponsor: GE HealthcareIndustry (pharma, biotech, devices)
Study start: Feb 2016
Primary completion: May 2016 (actual)
Study completion: May 2016 (actual)
First posted: 30 May 2016 (estimated)
Results: Posted 21 Jul 2017

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Diagnosis
Allocation: Non-randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Full Field Digital Mammography	Experimental	Device: Full Field Digital Mammography2-dimensional breast imaging
Digital Breast Tomosynthesis	Experimental	Device: Digital Breast Tomosynthesis3-dimensional breast imaging

Who may qualify

Ages: 40 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Are women aged 40 years or older (≥40 years old);
Have had a FFDM (Full Field Digital Mammography) or DBT (Digital Breast Tomosynthesis) breast imaging exam within 30 days prior to enrollment;
Have breast sizes compatible with the dimensions of a 24x29 cm image detector without anatomical cut-off;
Are able to walk without assistive devices;
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

Key exclusion criteria (5 listed)

Have been previously included in this study or are participating in another trial expected to interfere with study procedures or outcomes;
Have a history of breast biopsy, lumpectomy or mastectomy, or reconstruction on either breast;
Are currently lactating;
Are currently undergoing radiotherapy or chemotherapy , or have a history of prior radiotherapy treatment on either breast; or
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).

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Full Field Digital MammographyAlso: 2D Mammography	Device	Full Field Digital Mammography
Digital Breast TomosynthesisAlso: DBT	Device	Digital Breast Tomosynthesis

Primary outcome

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).

1 secondary outcome

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

Results and safety

Results posted to the registry on 21 Jul 2017, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Full Field Digital Mammography	14	14
Digital Breast Tomosynthesis	10	9

Primary outcome: Number of Participants With Acceptable Overall Clinical Image Quality

Time frame: At enrollment completion approximately 3 months post initiation. Count of participants. Unit: Participants

Measure	Full Field Digital Mammography n = 14	Digital Breast Tomosynthesis n = 9
Value	14	9

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Adverse events were monitored for the duration of subject participation in the study, which was approximately 2 months.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Full Field Digital Mammography	0 of 14 (0%)	0 of 14 (0%)	0 of 14
Digital Breast Tomosynthesis	0 of 10 (0%)	0 of 10 (0%)	0 of 10

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 7 Nov 2018.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Bruce Schroeder, MD principal investigator

Carolina Breast Imaging Specialists

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A study testing Full Field Digital Mammography and Digital Breast Tomosynthesis in people with Breast Health, run by GE Healthcare at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 7 Nov 2018. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

Yes. Results are posted in the registry (first posted 21 Jul 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Participants With Acceptable Overall Clinical Image Quality (time frame: At enrollment completion approximately 3 months post initiation). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02786004.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 Nov 2018; AzTrials last refreshed its copy on 1 Nov 2026.