Trial Outcomes & Findings for Patient-Assisted Compression - Impact on Image Quality and Workflow (NCT NCT03196635)

NCT ID: NCT03196635

Last Updated: 2018-08-31

Results Overview

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.

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 31 participants
• Primary outcome timeframe: Through study completion, on average 1 month
• Results posted on: 2018-08-31

Participant Flow

Participant milestones

Measure	All Study Participants All subjects will undergo their regularly scheduled full-field digital mammogram, consisting of bilateral, 2-view (craniocuadal \[CC\] and mediolateral oblique \[MLO\]) image acquisition. In addition, a study-specific, unilateral 2-view image set will obtained, utilizing the patient-assisted breast compression mode.
Overall Study STARTED	31
Overall Study COMPLETED	30
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	All Study Participants All subjects will undergo their regularly scheduled full-field digital mammogram, consisting of bilateral, 2-view (craniocuadal \[CC\] and mediolateral oblique \[MLO\]) image acquisition. In addition, a study-specific, unilateral 2-view image set will obtained, utilizing the patient-assisted breast compression mode.
Overall Study Withdrawal by Subject	1

Baseline Characteristics

Patient-Assisted Compression - Impact on Image Quality and Workflow

Baseline characteristics by cohort

Measure	All Study Participants n=31 Participants All subjects will undergo their regularly scheduled full-field digital mammogram, consisting of bilateral, 2-view (CC/MLO) image acquisition. In addition, a study-specific, unilateral 2-view image set will obtained, utilizing the patient-assisted breast compression mode. Patient-Assisted Breast Compression: 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.
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	23 Participants n=5 Participants
Age, Categorical >=65 years	8 Participants n=5 Participants
Sex: Female, Male Female	31 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants n=5 Participants
Breast of Interest First breast of interest	16 Participants n=5 Participants
Breast of Interest Second breast of interest	14 Participants n=5 Participants
Breast of Interest Withdrawn subject	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: Through study completion, on average 1 month

Population: 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.

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.

Outcome measures

Measure	All Study Participants, PA Compression Image Sets n=30 Participants All image sets (30 patient-assisted compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.	All Study Participants, TC Compression Image Sets n=30 Participants All image sets (30 TC compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.
Number of Subjects With Acceptable Overall Clinical Image Quality for Patient-assisted (PA) and Technologist-controlled (TC) Image Sets	30 Participants	30 Participants

SECONDARY outcome

Timeframe: Through study completion, on average 1 month

Population: Instances of repeat imaging for each subject's PA (N=30) and TC (N=30) image sets were indicated by technologists during image acquisitions and by readers during image evaluations. The one withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.

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.

Outcome measures

Measure	All Study Participants, PA Compression Image Sets n=30 Image sets All image sets (30 patient-assisted compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.	All Study Participants, TC Compression Image Sets n=30 Image sets All image sets (30 TC compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.
Repeat Image Acquisition Technologist-indicated Repeat	2 Image sets	7 Image sets
Repeat Image Acquisition Reader-indicated Repeat	4 Image sets	4 Image sets

SECONDARY outcome

Timeframe: Through study completion, on average 1 month

Population: The PA and TC image sets for all 30 subjects were evaluated for acceptability of pre-defined set of mammography attributes by Readers 1 and 2. Adjudication was not required if there was disagreement between the readers. The one withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.

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.

Outcome measures

Measure	All Study Participants, PA Compression Image Sets n=30 Participants All image sets (30 patient-assisted compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.	All Study Participants, TC Compression Image Sets n=30 Participants All image sets (30 TC compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.
Acceptability of Mammographic Attributes Acceptable Breast Positioning	30 image sets	29 image sets
Acceptability of Mammographic Attributes Acceptable exposure and visualization of tissue	30 image sets	30 image sets
Acceptability of Mammographic Attributes Acceptable breast compression	30 image sets	30 image sets
Acceptability of Mammographic Attributes Acceptable image contrast	30 image sets	30 image sets
Acceptability of Mammographic Attributes Acceptable sharpness of the image	30 image sets	30 image sets
Acceptability of Mammographic Attributes Acceptable tissue visibility at the skin line	30 image sets	30 image sets
Acceptability of Mammographic Attributes Acceptable noise level of the image	30 image sets	30 image sets
Acceptability of Mammographic Attributes Acceptable artifacts level	30 image sets	30 image sets

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, on average 1 month

Population: Imaging time was collected for each image set. 4 image sets were excluded from TC analysis due to repeat imaging per standard of care; repeat imaging wasn't allowed for PA compression. 1 subject's PA \& TC image sets were excluded from analysis due to a protocol deviation. 1 withdrawn subject did not undergo imaging, so was not part of the analysis.

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

Outcome measures

Measure	All Study Participants, PA Compression Image Sets n=29 Participants All image sets (30 patient-assisted compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.	All Study Participants, TC Compression Image Sets n=25 Participants All image sets (30 TC compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.
Comparison of Image Acquisition Time	3.9 minutes Standard Deviation 1.0	3.4 minutes Standard Deviation 1.0

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, on average 1 month

Population: Subjects underwent PA compression on their assigned Breast of Interest. Technologists were asked to provide confirmation if any intervention was necessary while the subject was controlling the compression. The one withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.

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

Outcome measures

Measure	All Study Participants, PA Compression Image Sets n=30 Participants All image sets (30 patient-assisted compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.	All Study Participants, TC Compression Image Sets All image sets (30 TC compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.
Technologist Interventions in PA Compression Technologist had to increase compression	0 Participants	—
Technologist Interventions in PA Compression Technologist had to decrease compression	1 Participants	—
Technologist Interventions in PA Compression No intervention required	29 Participants	—

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, on average 1 month

Population: Compression force (daN) was captured for each view under each compression for all subjects. The one withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.

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.

Outcome measures

Measure	All Study Participants, PA Compression Image Sets n=60 Image Views All image sets (30 patient-assisted compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.	All Study Participants, TC Compression Image Sets n=60 Image Views All image sets (30 TC compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.
Compression Force for PA and TC Compressions CC	9.1 daN Standard Deviation 3.0	8.3 daN Standard Deviation 2.0
Compression Force for PA and TC Compressions MLO	8.2 daN Standard Deviation 2.7	8.7 daN Standard Deviation 2.2

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, on average 1 month

Population: Breast thickness (mm) was captured for each view under each compression for all subjects. The one withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.

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.

Outcome measures

Measure	All Study Participants, PA Compression Image Sets n=60 Image Views All image sets (30 patient-assisted compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.	All Study Participants, TC Compression Image Sets n=60 Image Views All image sets (30 TC compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.
Breast Thickness for PA and TC Compressions CC	52.0 mm Standard Deviation 14.3	53.2 mm Standard Deviation 14.0
Breast Thickness for PA and TC Compressions MLO	54.6 mm Standard Deviation 16.1	53.7 mm Standard Deviation 15.1

OTHER_PRE_SPECIFIED outcome

Timeframe: Through study completion, on average 1 month

Population: ESAK was captured for each view under each compression for all subjects. The one withdrawn subject did not undergo image acquisition study procedures and thus was not included in this analysis set.

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.

Outcome measures

Measure	All Study Participants, PA Compression Image Sets n=60 Image Views All image sets (30 patient-assisted compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.	All Study Participants, TC Compression Image Sets n=60 Image Views All image sets (30 TC compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers.
Radiation Dose for PA and TC Compressions MLO	4.9 mGy Standard Deviation 2.6	4.8 mGy Standard Deviation 2.4
Radiation Dose for PA and TC Compressions CC	4.5 mGy Standard Deviation 2.4	4.7 mGy Standard Deviation 2.4

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

Sara Lam

GE Healthcare

Phone: 262-548-2369

Email: sara.j.lam@ge.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place

Restriction type: GT60