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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Patient-Assisted (PA) Breast Compression | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, on average 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Through study completion, on average 1 month |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of Image Acquisition Time | The length of time it takes for image acquisition using each compression mode (TC Compression and PA Compression) were compared. | Through study completion, on average 1 month |
| Technologist Interventions in PA Compression |
Inclusion Criteria:
Exclusion Criteria:
Asymptomatic women, aged 40 years or older scheduled for FFDM screening mammography
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| Name | Affiliation | Role |
|---|---|---|
| Kathy Schilling | Boca Raton Regional Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Boca Raton Regional Hospital Christine E. Lynn Women's Health and Wellness Institute | Boca Raton | Florida | 33486 | United States |
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| ID | Title | Description |
|---|---|---|
| FG000 | 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. |
| Title | Milestones | Reasons Not Completed | ||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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Subject population consisted of adult women (>/= 40 years of age) clinically indicated for an FFDM exam.
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| ID | Title | Description |
|---|---|---|
| BG000 | 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. |
| Units | Counts |
|---|---|
| Participants |
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| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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. | 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. | Posted | Count of Participants | Participants | Through study completion, on average 1 month |
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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.
The definition of adverse events and/or serious adverse events aligns with the definitions provided by clinicaltrials.gov.
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | All Study Participants | Except for one subject who withdrew from the study prior to imaging procedures, all subjects underwent their regularly scheduled full-field digital mammogram, consisting of bilateral, 2-view (CC and MLO) image acquisition. In addition, a study-specific, unilateral 2-view image set was obtained, utilizing the patient-assisted breast compression mode. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Sara Lam | GE Healthcare | 262-548-2369 | sara.j.lam@ge.com |
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | May 22, 2017 | Sep 18, 2017 | Prot_SAP_000.pdf |
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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| Technologist-Controlled (TC) Breast Compression | Device | TC compression will be conducted per standard of care practices at the site. |
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| 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. | 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.
| Through study completion, on average 1 month |
| Compression Force for PA and TC Compressions | 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. | Through study completion, on average 1 month |
| Breast Thickness for PA and TC Compressions | 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. | Through study completion, on average 1 month |
| Radiation Dose for PA and TC Compressions | 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. | Through study completion, on average 1 month |
| Participants |
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| Sex: Female, Male | Count of Participants | Participants |
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| Ethnicity (NIH/OMB) | Count of Participants | Participants |
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| Breast of Interest | One breast per eligible subject was randomly assigned as her 'breast of interest' which underwent study-specific procedures and image evaluations. Randomization of breast of interest was performed so that approximately half the subjects were assigned to the first breast imaged and the other half was assigned to the second breast imaged. The laterality of the breast of interest depended on which breast (left or right) the technologist imaged first and second in standard practice. | Count of Participants | Participants |
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| All Study Participants, PA Compression Image Sets |
All image sets (30 patient-assisted compression image sets) were evaluated for acceptability of overall clinical image quality by two (2) readers. |
| OG001 | 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. |
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| Secondary | 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. | 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. | Posted | Count of Units | Image sets | Through study completion, on average 1 month | Image sets | Image sets |
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| Secondary | 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. | 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. | Posted | Number | image sets | Through study completion, on average 1 month |
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| Other Pre-specified | Comparison of Image Acquisition Time | The length of time it takes for image acquisition using each compression mode (TC Compression and PA Compression) were compared. | 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. | Posted | Mean | Standard Deviation | minutes | Through study completion, on average 1 month |
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| Other Pre-specified | Technologist Interventions in PA Compression | Data will be collected regarding any interventions made by the technologist during PA compression and this data were summarized. | 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. | Posted | Count of Participants | Participants | Through study completion, on average 1 month |
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|
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| Other Pre-specified | Compression Force for PA and TC Compressions | 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. | 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. | Posted | Mean | Standard Deviation | daN | Through study completion, on average 1 month | Image Views | Image Views |
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|
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| Other Pre-specified | Breast Thickness for PA and TC Compressions | 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. | 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. | Posted | Mean | Standard Deviation | mm | Through study completion, on average 1 month | Image Views | Image Views |
|
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| Other Pre-specified | Radiation Dose for PA and TC Compressions | 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. | 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. | Posted | Mean | Standard Deviation | mGy | Through study completion, on average 1 month | Image Views | Image Views |
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| 0 |
| 30 |
| 0 |
| 30 |
| 0 |
| 30 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| Acceptable breast compression |
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| Acceptable image contrast |
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| Acceptable sharpness of the image |
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| Acceptable tissue visibility at the skin line |
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| Acceptable noise level of the image |
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| Acceptable artifacts level |
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