Breast Cancer3D PACNCT03456427

Patient-Assisted Compression in 3D - Impact on Image Quality and Workflow

A study testing Patient-Assisted Compression (PAC) in people with Breast Cancer, 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

Who is it for?: Ages 40 years and older, women onlyHealthy volunteers can take part
Conditions the study is for: Breast Cancer
What is being tested?: Patient-Assisted Compression (PAC)
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 36 participants
Where: 1 siteUnited States
Study dates: 4 Jan 2018to 9 Jan 2018
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
Women only
Healthy volunteers accepted
Adult, Older adult

Who may be able to join

Are women aged 40 years or older;
Are asymptomatic and scheduled for screening mammography;
Have left and right breasts;
Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;
Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy;
Are able and willing to comply with study procedures; and
Are able and willing to provide written informed consent to participate.

Who cannot join

Are women aged 40 years or older;
Are asymptomatic and scheduled for screening mammography;
Have left and right breasts;
Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;
Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy;
Are able and willing to comply with study procedures; and
Are able and willing to provide written informed consent to participate.

Trial locations and contacts

1 site in 1 country.

United States1 site

Boca Raton Regional Hospital
Boca Raton, Florida, 33486

Other trials in United States

About this study

Patient-assisted compression (PAC) allows the patient to participate in controlling the amount of compression force during mammography and is a personalized approach that has demonstrated successful reduction in discomfort experienced during mammography. General Electric Healthcare's Senographe Pristina, an innovative mammography platform that provides both two-dimensional (2D) and three-dimensional (3D) imaging capabilities, offers both standard and patient-assisted compression modes. This study will evaluate image quality and clinical workflow as it relates to use of PAC with the Senographe Pristina 3D.

Read the detailed description

The study population will consist of adult asymptomatic women presenting for screening 2D mammography. One breast of each subject will be identified as the "breast of interest," which will undergo study-specific 3D imaging consisting of two-view (craniocaudal and mediolateral oblique) PA compression and image acquisition, followed by two-view technologist-controlled (TC) compression and image acquisition. The breast of interest will be randomly assigned to either the first breast imaged during the exam or the second breast imaged. TC compression and imaging, and procedures performed on the subject's other breast will be conducted per standard of care.

Following image acquisition, 3D image quality evaluation will be conducted by Mammography Quality Standards Act-qualified readers. Prior to the reading session, images will be de-identified and the following information will be removed from the DICOM header to blind readers to the compression mode used during acquisition: time stamp, compression force, and breast thickness. The image sets will also be randomized for presentation during the image attribute reviews. Two (2) readers will evaluate each PAC and TC compression image set collected from each subject's breast of interest and assess the acceptability of image attributes, as defined in the Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full-Field Digital Mammography System (2012). A third reader will provide adjudication, if there is disagreement for a given image set's overall clinical image quality.

Workflow data, including the incidence of technologist intervention during acquisition and need for repeat image acquisition, will also be collected.

The proportion of PAC image sets that are of equal or higher acceptability than TC image sets will be calculated. A 95% confidence interval will be calculated using asymptotic method with continuity correction. The proportion of image sets indicated for repeated image acquisition when using PA mode or TC mode will be summarized. Other endpoint data will be summarized using descriptive statistics. No statistical hypothesis is being tested in this study.

Conditions: Breast Cancer
Being tested: Patient-Assisted Compression (PAC), Technologist-Controlled (TC) Compression
Medical subject headings: Breast Neoplasms

What participants receive

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

Patient-Assisted Compression (PAC)Device
The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views Craniocaudal (CC) \& Mediolateral Oblique (MLO).
Technologist-Controlled (TC) CompressionDevice
TC compression will be conducted per standard of care practices at the site.

Study groups in NCT03456427
Study group	Role	What they receive
All Study Participants	Other	All subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression. Receives: Device: Patient-Assisted Compression (PAC); Device: Technologist-Controlled (TC) Compression

What is being measured

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

Percentage of Acceptable Overall Image Quality
The primary objective is to compare the percentage of acceptable overall image quality in unilateral two-view (CC and MLO) breast images acquired using Patient-Assisted Compression and Technologist Compression modes.
Measured: 1 Day

Secondary outcomes (2)

Number of Repeat Image Acquisitions
To evaluate the need for repeat image acquisition when using Patient-Assisted Compression and Technologist Compression modes.
Measured: 1 Day
Percentage of Acceptable Mammographic Attributes
To evaluate the percentage of acceptable mammographic attributes for unilateral two-view breast images acquired using Patient-Assisted Compression and Technologist Compression modes.
Measured: 1 Day

Timeline

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

4 Jan 20189 Jan 2018

First posted7 Mar 2018
Study start4 Jan 2018
Primary completion9 Jan 2018
Study completion9 Jan 2018

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: Device feasibility
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Enrolment: 36 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03456427
Sponsor's protocol ID: 124.03-2017-GES-0005
Acronym: 3D PAC
Status last verified: Jan 2019
First submitted: 23 Feb 2018
Last updated: 5 Apr 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes

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 5 Apr 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Patient-Assisted Compression in 3D - Impact on Image Quality and Workflow
ClinicalTrials.gov ID: NCT03456427
Acronym / sponsor ID: 3D PAC / 124.03-2017-GES-0005
Conditions: Breast Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 36 participants (actual)
Lead sponsor: GE HealthcareIndustry (pharma, biotech, devices)
Study start: 4 Jan 2018 (actual)
Primary completion: 9 Jan 2018 (actual)
Study completion: 9 Jan 2018 (actual)
First posted: 7 Mar 2018 (actual)
Results: Posted 5 Apr 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

Workflow data, including the incidence of technologist intervention during acquisition and need for repeat image acquisition, will also be collected.

Study design

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

Arm	Type	Receives
All Study Participants	Other	Device: Patient-Assisted Compression (PAC), Device: Technologist-Controlled (TC) CompressionAll subjects will undergo standard of care imaging on one breast. The other breast will be imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression.

Who may qualify

Ages: 40 years and older
Sex: Female only
Healthy volunteers: Accepted
Age groups: Adult, Older adult

Key inclusion criteria (7 listed)

Are women aged 40 years or older;
Are asymptomatic and scheduled for screening mammography;
Have left and right breasts;
Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;
Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy;

Key exclusion criteria (7 listed)

Are women aged 40 years or older;
Are asymptomatic and scheduled for screening mammography;
Have left and right breasts;
Have breast sizes compatible with the dimensions of a 24 x 31 cm image detector, without anatomical cut-off;
Are documented as non-pregnant based on the investigator's medical judgment and in consideration of local clinical practice standards for evidence of non-pregnancy;

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
Patient-Assisted Compression (PAC)The technologist will properly position the breast and apply minimum compression. The subject will be instructed to apply compression as the technologist ensures the breast tissue is in appropriate position and tautness. The technologist will then guide the subject to achieve appropriate compression level, sufficient but not excessive, and the image will be acquired. This will be done for both standard views Craniocaudal (CC) \& Mediolateral Oblique (MLO).	Device	All Study Participants
Technologist-Controlled (TC) CompressionTC compression will be conducted per standard of care practices at the site.	Device	All Study Participants

Primary outcome

Percentage of Acceptable Overall Image Quality
Time frame: 1 Day
The primary objective is to compare the percentage of acceptable overall image quality in unilateral two-view (CC and MLO) breast images acquired using Patient-Assisted Compression and Technologist Compression modes.

2 secondary outcomes

Number of Repeat Image Acquisitions
Time frame: 1 Day
Percentage of Acceptable Mammographic Attributes
Time frame: 1 Day

Results and safety

Results posted to the registry on 5 Apr 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
All Study Participants	36	33

Primary outcome: Percentage of Acceptable Overall Image Quality

Time frame: 1 Day. Count of participants. Unit: Participants

Measure	All Study Participants: Patient Assisted Compression n = 33	All Study Participants: Technologist Compression n = 33
Image Quality: Acceptable	30	33
Image Quality: Unacceptable	3	0

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: 1 Day. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Study Participants	0 of 36 (0%)	0 of 36 (0%)	0 of 36

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Apr 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingPhase 1/2
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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.

The record lists no contact. Use the official record to reach the sponsor.

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

Questions about this trial

What is this clinical trial studying?

A study testing Patient-Assisted Compression (PAC) in people with Breast Cancer, 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 7 inclusion and 7 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 5 Apr 2019. 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 5 Apr 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?

Percentage of Acceptable Overall Image Quality (time frame: 1 Day). 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 NCT03456427.

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 5 Apr 2019.