Trial Outcomes & Findings for Patient-Assisted Compression in 3D - Impact on Image Quality and Workflow (NCT NCT03456427)

Last Updated: 2019-04-05

Results Overview

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.

Recruitment status

COMPLETED

Study phase

Target enrollment

36 participants

Primary outcome timeframe

1 Day

Results posted on

2019-04-05

Participant Flow

Participant milestones

Participant milestones
Measure	All Study Participants All subjects underwent standard of care imaging on one breast. The other breast was imaged using Patient-Assisted Compression (PAC), followed by Technologist-controlled (TC) Compression. Patient-Assisted Compression (PAC): The technologist properly positioned the breast and applied minimum compression. The subject was 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 was acquired. This was done for both standard views CC \& MLO. Technologist-Controlled (TC) Compression: TC compression was conducted per standard of care practices at the site.
Overall Study STARTED	36
Overall Study COMPLETED	33
Overall Study NOT COMPLETED	3

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	All Study Participants n=33 Participants 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. 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 CC \& MLO. Technologist-Controlled (TC) Compression: TC compression will be conducted per standard of care practices at the site.
Age, Continuous	66.45 years STANDARD_DEVIATION 10.99 • n=5 Participants
Sex: Female, Male Female	33 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	4 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Menopausal Status Post-Menopausal	29 Participants n=5 Participants
Menopausal Status Perimenopause	2 Participants n=5 Participants
Menopausal Status Pre-Menopausal	2 Participants n=5 Participants

PRIMARY outcome

Timeframe: 1 Day

Outcome measures

Outcome measures
Measure	All Study Participants: Patient Assisted Compression n=33 Participants 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. 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 CC \& MLO.	All Study Participants: Technologist Compression n=33 Participants 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. Technologist-Controlled (TC) Compression: TC compression will be conducted per standard of care practices at the site.
Percentage of Acceptable Overall Image Quality Image Quality: Acceptable	30 Participants	33 Participants
Percentage of Acceptable Overall Image Quality Image Quality: Unacceptable	3 Participants	0 Participants

SECONDARY outcome

Timeframe: 1 Day

To evaluate the need for repeat image acquisition when using Patient-Assisted Compression and Technologist Compression modes.

Outcome measures

Outcome measures
Measure	All Study Participants: Patient Assisted Compression n=33 Participants 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. 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 CC \& MLO.	All Study Participants: Technologist Compression n=33 Participants 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. Technologist-Controlled (TC) Compression: TC compression will be conducted per standard of care practices at the site.
Number of Repeat Image Acquisitions Technologist-Indicated Repeat Acquisitions · Repeat Acquisitions Indicated	1 Participants	0 Participants
Number of Repeat Image Acquisitions Technologist-Indicated Repeat Acquisitions · Repeat Acquisition not Indicated	32 Participants	33 Participants
Number of Repeat Image Acquisitions Reader-Indicated Repeat Acquisitions · Repeat Acquisitions Indicated	3 Participants	3 Participants
Number of Repeat Image Acquisitions Reader-Indicated Repeat Acquisitions · Repeat Acquisition not Indicated	30 Participants	30 Participants

SECONDARY outcome

Timeframe: 1 Day

To evaluate the percentage of acceptable mammographic attributes for unilateral two-view breast images acquired using Patient-Assisted Compression and Technologist Compression modes.

Outcome measures

Outcome measures
Measure	All Study Participants: Patient Assisted Compression n=33 Participants 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. 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 CC \& MLO.	All Study Participants: Technologist Compression n=33 Participants 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. Technologist-Controlled (TC) Compression: TC compression will be conducted per standard of care practices at the site.
Percentage of Acceptable Mammographic Attributes Noise · Acceptable	33 Participants	33 Participants
Percentage of Acceptable Mammographic Attributes Breast Positioning · Acceptable	29 Participants	32 Participants
Percentage of Acceptable Mammographic Attributes Breast Positioning · Unacceptable	4 Participants	1 Participants
Percentage of Acceptable Mammographic Attributes Exposure and Visualization · Acceptable	33 Participants	33 Participants
Percentage of Acceptable Mammographic Attributes Exposure and Visualization · Unacceptable	0 Participants	0 Participants
Percentage of Acceptable Mammographic Attributes Breast Compression · Acceptable	31 Participants	32 Participants
Percentage of Acceptable Mammographic Attributes Breast Compression · Unacceptable	2 Participants	1 Participants
Percentage of Acceptable Mammographic Attributes Sharpness due to Motion · Acceptable	32 Participants	31 Participants
Percentage of Acceptable Mammographic Attributes Sharpness due to Motion · Unacceptable	1 Participants	2 Participants
Percentage of Acceptable Mammographic Attributes Image Contrast · Acceptable	33 Participants	33 Participants
Percentage of Acceptable Mammographic Attributes Image Contrast · Unacceptable	0 Participants	0 Participants
Percentage of Acceptable Mammographic Attributes Tissue Visibility at skin line · Acceptable	31 Participants	32 Participants
Percentage of Acceptable Mammographic Attributes Tissue Visibility at skin line · Unacceptable	2 Participants	1 Participants
Percentage of Acceptable Mammographic Attributes Noise · Unacceptable	0 Participants	0 Participants
Percentage of Acceptable Mammographic Attributes Artifacts due to image processing or other factors · Acceptable	33 Participants	33 Participants
Percentage of Acceptable Mammographic Attributes Artifacts due to image processing or other factors · Unacceptable	0 Participants	0 Participants

Adverse Events

All Study Participants

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Beth Heckel

GE Healthcare

Phone: 1-262-312-7269

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place