Breast CancerADAPTNCT02306265

Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography

A study testing FFDM and DBT in people with Breast Cancer and Tumors, Breast, run by GE Healthcare at 2 sites 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

The aim of this recruitment plan (ADAPT-SCR) is to collect image and other data on both digital breast tomosynthesis (DBT) and full-field digital mammography (FFDM) from asymptomatic women undergoing screening mammography. Read more about this study

Who is it for?: Ages 30 years and older, women only
Conditions the study is for: Breast Cancer, Tumors, Breast, Cancer Screening
What is being tested?: FFDM and DBT
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 250 participants
Where: 2 sitesUnited States
Study dates: May 2015to 7 Jul 2017
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 30 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Women aged 30 years or older (≥30 years old);
Asymptomatic women scheduled for screening mammography or have completed a screening mammogram within the past 30 days;
Mammography completed on a General Electric (GE) GE FFDM system (with craniocaudal (CC) and mediolateral oblique (MLO) views) at the site or another clinical facility;
Are able and willing to comply with study procedures;
Have signed and dated the informed consent form;
Are either surgically sterile or postmenopausal or, if of childbearing potential, the possibility of pregnancy is remote based on a documented negative patient history and, optionally, a negative urine pregnancy test (if subject requests one).

Who cannot join

Have been previously included in this study;
Have a history of breast cancer and are in active treatment. However, subjects with a prior lumpectomy (> 5 years prior) who receive only routine screening mammography views can be included;
Have breasts too large to be adequately positioned on 24 x 31 centimeter (cm) FFDM digital receptor without anatomical cut off during either FFDM or DBT 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).

Trial locations and contacts

2 sites in 1 country.

United States2 sites

Allegheny General Hospital
Pittsburgh, Pennsylvania, 15212
Beaumont Health System
Royal Oak, Michigan, 48073

Other trials in United States

About this study

Official title: Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (ADAPT Trial) ADAPT-SCR: Recruitment Plan for Asymptomatic Women Undergoing Screening Mammography

Read the detailed description

ADAPT program consists of 2 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 undergo routine imaging with FFDM and will also have a DBT performed. They will continue with their standard of care treatment as would occur outside of the study. Based on the results of the FFDM and DBT, the subject's status will be followed-up with routing imaging at approximately 1 year (10-16 months). If the doctor recommends biopsy based on the FFDM or DBT, information about the biopsy and cancer determination results will be collected. Being in this study does not require subjects to have a biopsy that was not recommended by the doctor for normal medical care.

Conditions: Breast Cancer, Tumors, Breast, Cancer Screening
Being tested: FFDM, DBT
Medical subject headings: Breast Neoplasms

What participants receive

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

FFDMDevice
Also called Full-Field Digital Mammogram, 2D breast imaging
2D imaging of the breast using Full-Field Digital Mammography (FFDM) device
DBTDevice
Also called Digital Breast Tomosynthesis, 3D breast imaging
3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device

Study groups in NCT02306265
Study group	Role	What they receive
DBT and FFDM	Other	Subjects will undergo 2D breast imaging with full-field digital mammography (FFDM) device (active comparator) and 3D breast imaging with digital breast tomosynthesis (DBT) device (experimental). Receives: Device: FFDM; Device: DBT

What is being measured

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

Number of Participants With Imaging Data Collected
Collect breast image data using two (2) methods: Digital Breast Tomosynthesis (DBT) and Full Field Digital Mammography (FFDM) from asymptomatic women undergoing screening mammography.
Measured: within 30 days of enrollment

Timeline

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

May 20157 Jul 2017

First posted3 Dec 2014 (estimated)
Study startMay 2015
Primary completion7 Jul 2017
Study completion7 Jul 2017

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 CancerStudies 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: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 250 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02306265
Sponsor's protocol ID: 124.03-2014-GES-0010
Acronym: ADAPT
Status last verified: Jan 2019
First submitted: 1 Dec 2014
Last updated: 29 Jan 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
Individual data sharing: No: Individual participant data (IPD) will not be shared with other researchers

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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Study at a glance

From the registry record, last updated by the sponsor on 29 Jan 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Assessment of Diagnostic Accuracy and Performance of Digital Breast Tomosynthesis Compared to Mammography (ADAPT Trial) ADAPT-SCR: Recruitment Plan for Asymptomatic Women Undergoing Screening Mammography
ClinicalTrials.gov ID: NCT02306265
Acronym / sponsor ID: ADAPT / 124.03-2014-GES-0010
Conditions: Breast Cancer, Tumors, Breast, Cancer Screening
Study type: Interventional
Recruitment status: Completed
Enrolment: 250 participants (actual)
Lead sponsor: GE HealthcareIndustry (pharma, biotech, devices)
Study start: May 2015
Primary completion: 7 Jul 2017 (actual)
Study completion: 7 Jul 2017 (actual)
First posted: 3 Dec 2014 (estimated)
Results: Posted 29 Jan 2019

Clinical summary

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

Detailed description

Study design

Primary purpose: Screening
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1

Arm	Type	Receives
DBT and FFDM	Other	Device: FFDM, Device: DBTSubjects will undergo 2D breast imaging with full-field digital mammography (FFDM) device (active comparator) and 3D breast imaging with digital breast tomosynthesis (DBT) device (experimental).

Who may qualify

Ages: 30 years and older
Sex: Female only
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Women aged 30 years or older (≥30 years old);
Asymptomatic women scheduled for screening mammography or have completed a screening mammogram within the past 30 days;
Mammography completed on a General Electric (GE) GE FFDM system (with craniocaudal (CC) and mediolateral oblique (MLO) views) at the site or another clinical facility;
Are able and willing to comply with study procedures;
Have signed and dated the informed consent form;

Key exclusion criteria (6 listed)

Have been previously included in this study;
Have a history of breast cancer and are in active treatment. However, subjects with a prior lumpectomy (> 5 years prior) who receive only routine screening mammography views can be included;
Have breasts too large to be adequately positioned on 24 x 31 centimeter (cm) FFDM digital receptor without anatomical cut off during either FFDM or DBT 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);

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
FFDMAlso: Full-Field Digital Mammogram, 2D breast imaging2D imaging of the breast using Full-Field Digital Mammography (FFDM) device	Device	DBT and FFDM
DBTAlso: Digital Breast Tomosynthesis, 3D breast imaging3D imaging of the breast using Digital Breast Tomosynthesis (DBT) device	Device	DBT and FFDM

Primary outcome

Number of Participants With Imaging Data Collected
Time frame: within 30 days of enrollment
Collect breast image data using two (2) methods: Digital Breast Tomosynthesis (DBT) and Full Field Digital Mammography (FFDM) from asymptomatic women undergoing screening mammography.

Results and safety

Results posted to the registry on 29 Jan 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Mammography FFDM and DBT	250	249

Primary outcome: Number of Participants With Imaging Data Collected

Time frame: within 30 days of enrollment. Count of participants. Unit: Participants

Measure	Mammography FFDM and DBT n = 250
Participants with images collected by both methods	249
Participants with image collected by one method	1

Population analysed: The efficacy population for primary outcome were subjects meeting study inclusion/exclusion criteria with no protocol violations judged to affect the ability to evaluate the subject, whose DBT/FFDM images were diagnostically evaluable and whose mammography images were available for independent blinded evaluation, regardless of image quality.

Adverse events

Time frame: Time frame in which subjects were to complete the two scan types (up to 30 days).. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Mammography FFDM and DBT	0 of 250 (0%)	2 of 250 (0.8%)	0 of 250

Limitations and caveats (from the sponsor): The aim of this study (ADAPT-SCR) was to collect image data using two methods from asymptomatic women undergoing screening mammography. No statistical hypothesis was tested in this image collection study.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared with other researchers

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Not yet recruitingObservational study
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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.

Murray Rebner, MD principal investigator

Beaumont Health

William Poller, MD principal investigator

West Penn Allegheny Health System

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

Questions about this trial

What is this clinical trial studying?

A study testing FFDM and DBT in people with Breast Cancer and Tumors, Breast, run by GE Healthcare at 2 sites 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 6 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 29 Jan 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites 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 29 Jan 2019). 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 Imaging Data Collected (time frame: within 30 days of enrollment). 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 NCT02306265.

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 29 Jan 2019.