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The goal of this study is to evaluate patient comfort during compression with a standard flat mammographic paddle and an investigational curved paddle. This is a study that will be performed with x-ray imaging and will be used to determine if an overall reduction in pain can be appreciated in patients without loss in image quality as compared to the current standard mammogram. Another benefit of the curved paddle may be an increase of perceivable and measurable tissue capture.
The study will be conducted in the United States at up to 5 centers. The study will enroll up to 600 subjects. The number of subjects was chosen to allow evaluation of screening and diagnostic patients with a variety of breast densities (fatty, scattered densities, heterogeneously dense or extremely dense) and women with a range of breasts sizes that fit on the current detector. The evaluation of pain reduction will be the primary endpoint, while examining the potential of increased tissue capture without a compromise in image quality will be assessed as secondary endpoints. The enrollment will be consecutive for subjects who sign informed consent to participate. Women participating in the study will present for a screening or diagnostic imaging exam.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| STANDARD OF CARE | All the subjects enrolled in this study will be under a routine screening mammogram or undergoing a diagnostic mammogram using the standard of care (SOC) flat paddle. The Universal Pain Assessment Tool (UPAT) will be used to determine the comfort perception of each subject with the SOC paddle. The UPAT ranges from 0 to 10, where 0 represents 'no pain' and 10 'worst pain possible'. |
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| INVESTIGATIONAL | All the subjects enrolled in this study will be under a routine screening mammogram or undergoing a diagnostic mammogram using the investigational (INV) curved paddle. The Universal Pain Assessment Tool (UPAT) will be used to determine the comfort perception of each subject with the INV paddle. The UPAT ranges from 0 to 10, where 0 represents 'no pain' and 10 'worst pain possible'. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Standard of Care Flat Paddle | Device | X-Ray Mammogram Exam. Each screening subject will receive a 4-view 2D plus 3D combination imaging: Left Cranial Caudal (LCC), Left Medial Oblique (LMO), Right Cranial Caudal (RCC), and Right Medial Oblique (RMLO) with the current standard of care (SOC) flat paddle. Each diagnostic subject will have her prescribed diagnostic 2D plus 3D combination imaging (CC or MLO) with the SOC flat paddle. The image view (CC or MLO) will be based on the visibility of the area of interest for which the diagnostic imaging was ordered. The amount of compression applied in all mammograms will be to achieve tautness. |
| Measure | Description | Time Frame |
|---|---|---|
| Subject Comfort | The Universal Pain Assessment Tool (UPAT) was used to assess each subject's comfort perception with each paddle (SOC and INV). The UPAT ranges from 0 to 10, where 0 represents 'no pain' and 10 'worst pain possible'. | 1 day (Day of procedure, No follow-up) |
| Measure | Description | Time Frame |
|---|---|---|
| Breast Tissue Coverage | An expert technologist evaluated the performance of the SOC and the INV paddles in 388 subjects. For each participant, the technologist answered which paddle was better at pulling in more breast tissue during imaging between SOC and INV (all subjects were imaged with both paddles during the same session). The technologist rated the paddles using a 5-point Likert scale, where -2 and -1 values mean that the SOC paddle performed better or slightly better, 0 means equal performance between paddles, and 2 and 1 mean that the INV performed better or slightly better than the SOC paddle. Note that different technologists were involved in the image acquisition. An acceptable tissue coverage for this study refers to having sufficient breast tissue (a balance between fatty and glandular tissue) in the image acquired so that any potential abnormalities can be effectively identified. |
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Inclusion Criteria:
Exclusion Criteria:
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Women participating in the study will present for a screening or diagnostic imaging breast exam.
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| Name | Affiliation | Role |
|---|---|---|
| Muhammad Waqas | Hologic, Inc. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stamford Hospital | Stamford | Connecticut | 06902 | United States | ||
| Elizabeth Wende Breast Clinic |
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This study involved subjects undergoing a mammogram exam (screening or diagnostic).
All subjects were X-ray imaged using the standard of care (SOC) flat paddle and the investigational (INV) curved paddle. Thus, the subjects in the SOC group were the same as those in the INV group.
A total of 443 subjects were initially enrolled. Of those, 14 did not complete the study.
Subjects were recruited based on inclusion/exclusion criteria from protocol 16-03 at 4 clinical sites between October 2016 and June 2018.
| ID | Title | Description |
|---|---|---|
| FG000 | Standard of Care Flat Paddle | Subjects involved in this study underwent a screening routine mammogram or a diagnostic mammogram using the standard of care (SOC) flat paddle. A screening mammogram involved 4-image views (both breasts: LCC, LMO, RCC, RMLO) with the SOC paddle. A diagnostic mammogram involved 2-image views (CC and MLO) of the breast of interest with the SOC paddle. |
| FG001 | Investigational Curved Paddle | Subjects involved in this study underwent a screening routine mammogram or a diagnostic mammogram using the investigational (INV) curved paddle. A screening mammogram involved 2-image views (CC and MLO) in one of the breasts as determined by a randomization scheme. A diagnostic mammogram involved 2-image views (CC and MLO) of the breast of interest only. |
| Title | Milestones | Reasons Not Completed | |||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
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This study involves subjects undergoing a mammogram exam (screening or diagnostic).
These subjects were X-ray imaged using the SOC and INV paddles to determine changes in their comfort level and establish a direct comparison between devices.
This means the subjects in the SOC group are the same as those in the INV group.
This section consolidates (combines) all the subjects enrolled as one group rather than two groups because we're evaluating both devices on the same subjects.
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| ID | Title | Description |
|---|---|---|
| BG000 | All Enrolled Subjects | This study involves subjects undergoing a mammogram exam (screening or diagnostic). These subjects were X-ray imaged using the SOC and INV paddles to determine changes in their comfort level and establish a direct comparison between devices. This means the subjects in the SOC group are the same as those in the INV group. This section consolidates (combines) all the subjects enrolled as one group rather than two groups because we're evaluating both devices on the same subjects. |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Subjects analyzed based on complete data set availability |
| 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 | Subject Comfort | The Universal Pain Assessment Tool (UPAT) was used to assess each subject's comfort perception with each paddle (SOC and INV). The UPAT ranges from 0 to 10, where 0 represents 'no pain' and 10 'worst pain possible'. | The number of participants analyzed per group differs from the number provided in the Participant Flow module (429). Two subjects' pain scores were unclear when imaged with the INV paddle. For this reason, the analysis was done by contemplating 427 subjects. Three subjects' pain scores were unclear when imaged with the INV paddle. For this reason, the analysis was done by contemplating 426 subjects. | Posted | Mean | 95% Confidence Interval | score on a scale | 1 day (Day of procedure, No follow-up) |
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1 day (Day of procedure, No follow-up)
For this study, the subjects in the SOC group are the same as those in the INV group.
All subjects were combined in a single group for the adverse event reporting because we're evaluating both devices on the same subjects.
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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 Enrolled Subjects | This study involves subjects undergoing a screening mammogram or diagnostic exams. These subjects were imaged using the SOC and INV paddles to determine changes in their perception of comfort and establish a valid comparison. The subjects in the SOC group are the same as those in the INV group. For this reason, the subjects were consolidated as one group, which involved all the subjects enrolled in the study. |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Muhammad Waqas, Director of Global Clinical Affairs, BSH | Hologic, Inc. | (508) 263-8935 | ClinicalResearch@Hologic.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 | Jan 15, 2018 | Oct 21, 2022 | Prot_SAP_000.pdf |
| ICF | No | No | Yes | Informed Consent Form | Sep 15, 2016 | Oct 21, 2022 | ICF_001.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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|
| Investigational Curved Paddle | Device | X-Ray Mammogram Exam. Each screening subject will receive a CC and an MLO in one of her breasts as determined by a randomization scheme with the investigational (INV) curved paddle. Each diagnostic subject will have her prescribed diagnostic 2D plus 3D combination imaging (CC or MLO) with the INV curved paddle. The image view (CC or MLO) will be based on the visibility of the area of interest for which the diagnostic imaging was ordered. The amount of compression applied in all mammograms will be to achieve tautness. |
|
| 1 Day (Day of procedure, No Follow-up) |
| Overall Determination of Image Quality | An expert radiologist reviewed, side by side, 3D images acquired with the INV and the SOC paddles in 420 subjects. The radiologist rated the images using a 5-point Likert scale, where -2 and -1 values mean that the images acquired with the SOC paddle have better or slightly better quality, 0 means equal quality between the images, and 2 and 1 mean that the images acquired with the INV paddle have better or slightly better quality than the SOC paddle. To determine overall clinical image quality or image acceptability, the radiologist considered whether the images reviewed have fair lesion visibility (when a lesion is present), good breast tissue separations of structures, good breast tissue coverage, no artifacts due to patient motion, and can be used to determine breast tissue density. Note that not all the 420 images were reviewed by the same radiologist. | 1 day (Day of procedure, No Follow-up) |
| Rochester |
| New York |
| 14620 |
| United States |
| Solis Mammagroaphy | Addison | Texas | 75001 | United States |
| TOPS Comprehensive Breast Center | Houston | Texas | 77090 | United States |
| Protocol Violation |
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| Device failure |
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| Missing information |
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| Mean |
| Standard Deviation |
| years |
|
| Sex: Female, Male | Subjects analyzed based on complete data set availability | Count of Participants | Participants |
|
| Race/Ethnicity, Customized | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| BI-RADS Breast Density Assessment | Number | participants |
|
| OG001 | STANDARD OF CARE | All the subjects enrolled in this study will be under a routine screening mammogram or undergoing a diagnostic mammogram using the standard of care (SOC) flat paddle. |
|
|
|
| Secondary | Breast Tissue Coverage | An expert technologist evaluated the performance of the SOC and the INV paddles in 388 subjects. For each participant, the technologist answered which paddle was better at pulling in more breast tissue during imaging between SOC and INV (all subjects were imaged with both paddles during the same session). The technologist rated the paddles using a 5-point Likert scale, where -2 and -1 values mean that the SOC paddle performed better or slightly better, 0 means equal performance between paddles, and 2 and 1 mean that the INV performed better or slightly better than the SOC paddle. Note that different technologists were involved in the image acquisition. An acceptable tissue coverage for this study refers to having sufficient breast tissue (a balance between fatty and glandular tissue) in the image acquired so that any potential abnormalities can be effectively identified. | The number of participants analyzed per group differs from the number provided in the Participant Flow module (429). Technologists did not provide an answer to the question about preference for tissue coverage in 41 cases. For this reason, the analysis was done in 388 subjects only. The same 388 subjects are part of both groups: INV and SOC groups. Therefore, the results are shown combined in the data table. | Posted | Count of Participants | Participants | 1 Day (Day of procedure, No Follow-up) |
|
|
|
| Secondary | Overall Determination of Image Quality | An expert radiologist reviewed, side by side, 3D images acquired with the INV and the SOC paddles in 420 subjects. The radiologist rated the images using a 5-point Likert scale, where -2 and -1 values mean that the images acquired with the SOC paddle have better or slightly better quality, 0 means equal quality between the images, and 2 and 1 mean that the images acquired with the INV paddle have better or slightly better quality than the SOC paddle. To determine overall clinical image quality or image acceptability, the radiologist considered whether the images reviewed have fair lesion visibility (when a lesion is present), good breast tissue separations of structures, good breast tissue coverage, no artifacts due to patient motion, and can be used to determine breast tissue density. Note that not all the 420 images were reviewed by the same radiologist. | The number of participants analyzed per group differs from the number provided in the Participant Flow module (429). Data results related to image quality were unclear in nine subjects. For this reason, the analysis considered only 420 subjects. These 420 subjects are the same in both groups, INV and SOC, so the images can be comparable. Therefore, the results shown are combined in the data table. | Posted | Count of Participants | Participants | 1 day (Day of procedure, No Follow-up) |
|
|
|
| 0 |
| 429 |
| 0 |
| 429 |
| 0 |
| 429 |
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| D017437 |
| Skin and Connective Tissue Diseases |
| Title | Measurements |
|---|---|
|
| Title | Measurements |
|---|---|
|