Who is sponsoring NCT03196635?

NCT03196635 is sponsored by GE Healthcare.

What drugs are being tested in NCT03196635?

Interventions in NCT03196635: Patient-Assisted (PA) Breast Compression, Technologist-Controlled (TC) Breast Compression.

What condition does NCT03196635 study?

NCT03196635 studies Breast Cancer.

Is NCT03196635 still recruiting?

NCT03196635 is currently completed. Last updated 31 August 2018.

Are results published for NCT03196635?

Yes — primary outcome results have been posted to ClinicalTrials.gov. See the outcomes section above for details.

Last reviewed 2018-08-31 · How we verify

NCT03196635

Name: Drug Landscape Pharmaceutical Database
Creator: Drug Landscape
Published: 2026-01-01
License: https://creativecommons.org/licenses/by/4.0/

Patient-Assisted Compression - Impact on Image Quality and Workflow

Completed NA Results posted Last updated 31 August 2018

What this trial tests

NA trial testing Patient-Assisted (PA) Breast Compression in Breast Cancer in 31 participants. Completed in 29 June 2017.

Timeline

19 June 2017

Primary endpoint
29 June 2017

29 June 2017

Quick facts

Lead sponsor	GE Healthcare
Phase	NA
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	screening
Enrollment	31
Start date	19 June 2017
Primary completion	29 June 2017
Estimated completion	29 June 2017
Sites	1 location across United States

Drugs / interventions tested

Patient-Assisted (PA) Breast Compression
Technologist-Controlled (TC) Breast Compression

Conditions studied

Breast Cancer — all drugs for Breast Cancer →

Sponsor

GE Healthcare — full company profile →

Who can join

40 and older, female only, with Breast Cancer. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

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

Group	Value	95% CI
All Study Participants, PA Compression Image Sets	30
All Study Participants, TC Compression Image Sets	30

Repeat Image Acquisition Secondary · Through study completion, on average 1 month

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.

Technologist-indicated Repeat

Group	Value	95% CI
All Study Participants, PA Compression Image Sets	2
All Study Participants, TC Compression Image Sets	7

Reader-indicated Repeat

Group	Value	95% CI
All Study Participants, PA Compression Image Sets	4
All Study Participants, TC Compression Image Sets	4

Acceptability of Mammographic Attributes Secondary · Through study completion, on average 1 month

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.

Acceptable Breast Positioning

Group	Value	95% CI
All Study Participants, PA Compression Image Sets	30
All Study Participants, TC Compression Image Sets	29

Acceptable exposure and visualization of tissue

Group	Value	95% CI
All Study Participants, PA Compression Image Sets	30
All Study Participants, TC Compression Image Sets	30

Acceptable breast compression

Group	Value	95% CI
All Study Participants, PA Compression Image Sets	30
All Study Participants, TC Compression Image Sets	30

Acceptable image contrast

Group	Value	95% CI
All Study Participants, PA Compression Image Sets	30
All Study Participants, TC Compression Image Sets	30

Acceptable sharpness of the image

Group	Value	95% CI
All Study Participants, PA Compression Image Sets	30
All Study Participants, TC Compression Image Sets	30

Acceptable tissue visibility at the skin line

Group	Value	95% CI
All Study Participants, PA Compression Image Sets	30
All Study Participants, TC Compression Image Sets	30

Acceptable noise level of the image

Group	Value	95% CI
All Study Participants, PA Compression Image Sets	30
All Study Participants, TC Compression Image Sets	30

Acceptable artifacts level

Group	Value	95% CI
All Study Participants, PA Compression Image Sets	30
All Study Participants, TC Compression Image Sets	30

Comparison of Image Acquisition Time Secondary · Through study completion, on average 1 month

The length of time it takes for image acquisition using each compression mode (TC Compression and PA Compression) were compared.

Group	Value	95% CI
All Study Participants, PA Compression Image Sets	3.9	± 1.0
All Study Participants, TC Compression Image Sets	3.4	± 1.0

Technologist Interventions in PA Compression Secondary · Through study completion, on average 1 month

Data will be collected regarding any interventions made by the technologist during PA compression and this data were summarized.

Group	Value	95% CI
All Study Participants	0
All Study Participants	1
All Study Participants	29

Compression Force for PA and TC Compressions Secondary · Through study completion, on average 1 month

Compression forces (decanewton \[daN\]) for each compression mode (TC and PA compression) were summarized for craniocaudal (CC) and mediolateral oblique (MLO) views. For each subject, both views were collected using both compression modes.

Group	Value	95% CI
All Study Participants, PA Compression Image Sets	9.1	± 3.0
All Study Participants, TC Compression Image Sets	8.3	± 2.0

MLO

Group	Value	95% CI
All Study Participants, PA Compression Image Sets	8.2	± 2.7
All Study Participants, TC Compression Image Sets	8.7	± 2.2

Breast Thickness for PA and TC Compressions Secondary · Through study completion, on average 1 month

Breast thickness (millimeter \[mm\]) for each compression mode (TC and PA compression) were summarized for craniocaudal (CC) and mediolateral oblique (MLO) views. For each subject, both views were collected using both compression modes.

Group	Value	95% CI
All Study Participants, PA Compression Image Sets	52.0	± 14.3
All Study Participants, TC Compression Image Sets	53.2	± 14.0

MLO

Group	Value	95% CI
All Study Participants, PA Compression Image Sets	54.6	± 16.1
All Study Participants, TC Compression Image Sets	53.7	± 15.1

Radiation Dose for PA and TC Compressions Secondary · Through study completion, on average 1 month

Radiation dose (entrance skin air kerma \[ESAK\] in milligray \[mGy\]) for each compression mode (TC and PA compression) were summarized for craniocaudal (CC) and mediolateral oblique (MLO) views. For each subject, both views were collected using both compression modes.

Group	Value	95% CI
All Study Participants, PA Compression Image Sets	4.5	± 2.4
All Study Participants, TC Compression Image Sets	4.7	± 2.4

MLO

Group	Value	95% CI
All Study Participants, PA Compression Image Sets	4.9	± 2.6
All Study Participants, TC Compression Image Sets	4.8	± 2.4

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

Verify or expand the search:

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Verify against primary sources

ClinicalTrials.gov — authoritative US registry record
WHO ICTRP — international registry index
EU Clinical Trials Register
Sponsor press releases (Google)

Data sources for this page

Trial protocol + status: ClinicalTrials.gov NCT03196635 (US National Library of Medicine, public domain)
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by GE Healthcare
Last refreshed: 31 August 2018

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03196635.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing