Breast CancerNCT03196635

Patient-Assisted Compression - Impact on Image Quality and Workflow

A study testing Patient-Assisted (PA) Breast Compression 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

This study is being conducted to compare the image quality of breast images obtained using standard (technologist-controlled [TC]) compression and patient-assisted (PA) compression and to evaluate the impact of PA compression on clinical workflow. Read more about this study

Who is it for?: Ages 40 years and older, women only
Conditions the study is for: Breast Cancer
What is being tested?: Patient-Assisted (PA) Breast Compression
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 31 participants
Where: 1 siteUnited States
Study dates: 19 Jun 2017to 29 Jun 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 40 years and older
Women only
No healthy volunteers
Adult, Older adult

Who may be able to join

Are women aged 40 years or older;
Are asymptomatic and scheduled for FFDM 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

Have been previously included in this study or are participating in another study expected to interfere with study procedures or outcomes;
Have undergone diagnostic or surgical intervention(s) or procedure(s) on either breast, including breast biopsy, lumpectomy, or reconstruction, within five (5) years (≤ 5 years) of the study exam date;
Are currently undergoing radiotherapy or chemotherapy, or have a history of prior radiotherapy treatment on either breast;
Are currently lactating; or
Have breast implants.

Trial locations and contacts

1 site in 1 country.

United States1 site

Boca Raton Regional Hospital Christine E. Lynn Women's Health and Wellness Institute
Boca Raton, Florida, 33486

Other trials in United States

About this study

Read the detailed description

Patient-assisted (PA) compression 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. GE Healthcare's Senographe Pristina, an innovative mammography platform that provides both two-dimensional (2D) and three-dimensional (3D) imaging capabilities, offers both standard and PA compression modes. This study is being conducted to compare the image quality of breast images obtained using TC compression and PA compression, and to evaluate the impact of PA compression on clinical workflow. The study population will consist of adult asymptomatic women presenting for screening 2D mammography.

Conditions: Breast Cancer
Being tested: Patient-Assisted (PA) Breast Compression, Technologist-Controlled (TC) Breast 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 (PA) Breast CompressionDevice
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 CC \& MLO.
Technologist-Controlled (TC) Breast CompressionDevice
TC compression will be conducted per standard of care practices at the site.

Study groups in NCT03196635
Study group	Role	What they receive
All Study Participants	Experimental	All subjects will undergo their regularly scheduled full-field digital mammogram, consisting of bilateral, 2-view (craniocaudal [CC] and mediolateral oblique [MLO]) image acquisition. In addition, a study-specific, unilateral 2-view image set will obtained, utilizing the PA breast compression mode. Receives: Device: Patient-Assisted (PA) Breast Compression; Device: Technologist-Controlled (TC) Breast Compression

What is being measured

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

Number of Subjects With Acceptable Overall Clinical Image Quality for Patient-assisted (PA) and Technologist-controlled (TC) Image Sets
One PA image set and one TC image set was acquired from each completed subject. The overall clinical image quality acceptability was collected and summarized on a per subject-basis using binary responses of either acceptable or unacceptable for unilateral, two-view PA and TC compression image sets. Two readers evaluated each of the 60 image sets (30 PA and 30 TC compression image sets from 30 completed participants). In cases of disagreement between Readers 1 and 2, a third reader provided adjudication.
Measured: Through study completion, on average 1 month

Secondary outcomes (2)

Repeat Image Acquisition
Number of incidences per image set when the technologists or readers indicated a repeat acquisition for PA and TC compression modes. More than one incident (i.e. reason for repeat from technologist or view indicated for repeat by readers) could have been selected for a given image set.
Measured: Through study completion, on average 1 month
Acceptability of Mammographic Attributes
Acceptability of mammographic attributes using a binary response of either acceptable or unacceptable for unilateral, two-view PA and TC compression image sets were summarized.
Measured: Through study completion, on average 1 month

Timeline

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

19 Jun 201729 Jun 2017

First posted23 Jun 2017
Study start19 Jun 2017
Primary completion29 Jun 2017
Study completion29 Jun 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: 31 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT03196635
Sponsor's protocol ID: 124.03-2017-GES-0002
Status last verified: Aug 2018
First submitted: 19 Jun 2017
Last updated: 31 Aug 2018
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: No
FDA-regulated device: Yes
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?

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Study at a glance

From the registry record, last updated by the sponsor on 31 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Patient-Assisted Compression - Impact on Image Quality and Workflow
ClinicalTrials.gov ID: NCT03196635
Acronym / sponsor ID: 124.03-2017-GES-0002
Conditions: Breast Cancer
Study type: Interventional
Recruitment status: Completed
Enrolment: 31 participants (actual)
Lead sponsor: GE HealthcareIndustry (pharma, biotech, devices)
Study start: 19 Jun 2017 (actual)
Primary completion: 29 Jun 2017 (actual)
Study completion: 29 Jun 2017 (actual)
First posted: 23 Jun 2017 (actual)
Results: Posted 31 Aug 2018

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
All Study Participants	Experimental	Device: Patient-Assisted (PA) Breast Compression, Device: Technologist-Controlled (TC) Breast CompressionAll subjects will undergo their regularly scheduled full-field digital mammogram, consisting of bilateral, 2-view (craniocaudal [CC] and mediolateral oblique [MLO]) image acquisition. In addition, a study-specific, unilateral 2-view image set will obtained, utilizing the PA breast compression mode.

Who may qualify

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

Key inclusion criteria (7 listed)

Are women aged 40 years or older;
Are asymptomatic and scheduled for FFDM 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 (5 listed)

Have been previously included in this study or are participating in another study expected to interfere with study procedures or outcomes;
Have undergone diagnostic or surgical intervention(s) or procedure(s) on either breast, including breast biopsy, lumpectomy, or reconstruction, within five (5) years (≤ 5 years) of the study exam date;
Are currently undergoing radiotherapy or chemotherapy, or have a history of prior radiotherapy treatment on either breast;
Are currently lactating; or
Have breast implants.

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 (PA) Breast CompressionThe 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 CC \& MLO.	Device	All Study Participants
Technologist-Controlled (TC) Breast CompressionTC compression will be conducted per standard of care practices at the site.	Device	All Study Participants

Primary outcome

Number of Subjects With Acceptable Overall Clinical Image Quality for Patient-assisted (PA) and Technologist-controlled (TC) Image Sets
Time frame: Through study completion, on average 1 month
One PA image set and one TC image set was acquired from each completed subject. The overall clinical image quality acceptability was collected and summarized on a per subject-basis using binary responses of either acceptable or unacceptable for unilateral, two-view PA and TC compression image sets. Two readers evaluated each of the 60 image sets (30 PA and 30 TC compression image sets from 30 completed participants). In cases of disagreement between Readers 1 and 2, a third reader provided adjudication.

2 secondary outcomes

Repeat Image Acquisition
Time frame: Through study completion, on average 1 month
Acceptability of Mammographic Attributes
Time frame: Through study completion, on average 1 month

Results and safety

Results posted to the registry on 31 Aug 2018, 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	31	30

Primary outcome: Number of Subjects With Acceptable Overall Clinical Image Quality for Patient-assisted (PA) and Technologist-controlled (TC) Image Sets

Time frame: Through study completion, on average 1 month. Count of participants. Unit: Participants

Measure	All Study Participants, PA Compression Image Sets n = 30	All Study Participants, TC Compression Image Sets n = 30
Value	30	30

Population analysed: 60 image sets (30 PA and 30 TC compression image sets from 30 participants) were evaluated for acceptability of overall clinical image quality by two readers. The one (1) withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were monitored for the duration of subject participation in the study, which was less than 1 month. Each subject was followed for Adverse Events from the time she entered the imaging suite for her exam until the time she exited the imaging suite after the exam.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
All Study Participants	0 of 30 (0%)	0 of 30 (0%)	0 of 30

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 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.

Kathy Schilling principal investigator

Boca Raton Regional Hospital

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 (PA) Breast Compression 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 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 31 Aug 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 31 Aug 2018). 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 Subjects With Acceptable Overall Clinical Image Quality for Patient-assisted (PA) and Technologist-controlled (TC) Image Sets (time frame: Through study completion, on average 1 month). 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 NCT03196635.

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 31 Aug 2018.