Patient-Assisted Compression - Impact on Image Quality and Workflow

Status

Completed

Phases

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT03196635

Enrollment

Registered

2017-06-23

Start date

2017-06-19

Completion date

2017-06-29

Last updated

2018-08-31

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief 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.

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.

Interventions

DEVICEPatient-Assisted (PA) 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.

DEVICETechnologist-Controlled (TC) Breast Compression

TC compression will be conducted per standard of care practices at the site.

Study design

Allocation

Intervention model

SINGLE_GROUP

Primary purpose

SCREENING

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

40 Years to No maximum

Healthy volunteers

Inclusion criteria

* 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.

Exclusion criteria

* 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.

Design outcomes

Primary

Measure	Time frame	Description
Number of Subjects With Acceptable Overall Clinical Image Quality for Patient-assisted (PA) and Technologist-controlled (TC) Image Sets	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.

Secondary

Measure	Time frame	Description
Repeat Image Acquisition	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.
Acceptability of Mammographic Attributes	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.

Other

Measure	Time frame	Description
Breast Thickness for PA and TC Compressions	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.
Comparison of Image Acquisition Time	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.
Radiation Dose for PA and TC Compressions	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.
Technologist Interventions in PA Compression	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.
Compression Force for PA and TC Compressions	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.

Countries

United States

Participant flow

Participants by arm

Arm	Count
All Study 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.	31
Total	31

Arm

Count

All Study 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.

Total

Withdrawals & dropouts

Period	Reason	FG000
Overall Study	Withdrawal by Subject	1

Baseline characteristics

Characteristic	All Study Participants
Age, Categorical <=18 years	0 Participants
Age, Categorical >=65 years	8 Participants
Age, Categorical Between 18 and 65 years	23 Participants
Breast of Interest First breast of interest	16 Participants
Breast of Interest Second breast of interest	14 Participants
Breast of Interest Withdrawn subject	1 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	1 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	29 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	1 Participants
Sex: Female, Male Female	31 Participants
Sex: Female, Male Male	0 Participants

Adverse events

Event type	EG000 affected / at risk
deaths Total, all-cause mortality	0 / 30
other Total, other adverse events	0 / 30
serious Total, serious adverse events	0 / 30

Outcome results

Primary

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.