An observational study in Breast Cancer, sponsored by Hologic, Inc.. Completed at 4 sites in United States. Open to female participants aged 25 Years and older, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-05-21.
Sponsored by Hologic, Inc. · Observational
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.
14,825 studies on the registry are indexed under Breast Neoplasms; 3,319 are open to participants now.
This study's enrollment of 443 is above the median of 184 across 3,235 observational studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Hologic, Inc. is the lead sponsor of 28 studies on the registry; none are open to participants now.
Counted across the registry records on this site, refreshed daily.
Women participating in the study will present for a screening or diagnostic imaging breast exam.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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'.
Device: Standard of Care Flat Paddle
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'.
Device: Investigational Curved Paddle
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.
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.
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'.
Time frame: 1 day (Day of procedure, No follow-up)
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.
Time frame: 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.
Time frame: 1 day (Day of procedure, No Follow-up)
Subjects were recruited based on inclusion/exclusion criteria from protocol 16-03 at 4 clinical sites between October 2016 and June 2018.
| Milestone | Standard of Care Flat Paddle | Investigational Curved Paddle |
|---|---|---|
| Started | 443 | 443 |
| Completed | 429 | 429 |
| Not completed | 14 | 14 |
| Withdrew: Withdrawal by subject | 4 | 4 |
| Withdrew: Physician decision | 1 | 1 |
| Withdrew: Protocol violation | 2 | 2 |
| Withdrew: Device failure | 2 | 2 |
| Withdrew: Missing information | 5 | 5 |
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'.
| score on a scale | INVESTIGATIONAL | STANDARD OF CARE |
|---|---|---|
| Subject Comfort | 2.6 (2.3 to 2.6) | 4.0 (3.6 to 4.1) |
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.
| Participants | All Enrolled Subjects |
|---|---|
| Rate -2 or -1 (SOC better or slightly better than INV) | 69 |
| Rate 0 ( SOC equal INV) | 162 |
| Rate 2 or 1 ( INV better or slightly better than SOC) | 157 |
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.
| Participants | All Enrolled Subjects |
|---|---|
| Rate -2 or -1 (SOC better or slightly better than INV) | 27 |
| Rate 0 (SOC equal INV) | 330 |
| Rate 2 or 1 (INV better or slightly better than SOC) | 63 |
Collected over 1 day (Day of procedure, No follow-up). Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| All Enrolled Subjects | 0/429 (0%) | 0/429 (0%) | 0/429 (0%) |
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.
| Age, Continuous(years) | All Enrolled Subjects |
|---|---|
| Mean | 54.6 ± 11 |
| Sex: Female, Male(Participants) | All Enrolled Subjects |
|---|---|
| Female | 429 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | All Enrolled Subjects |
|---|---|
| White | 374 |
| African American/Black | 29 |
| Hispanic/Latino | 20 |
| Asian | 2 |
| Indian/Persian | 3 |
| Unknown | 1 |
| Region of Enrollment(participants) | All Enrolled Subjects |
|---|---|
| United States | 429 |
| BI-RADS Breast Density Assessment(participants) | All Enrolled Subjects |
|---|---|
| Type A (Breasts are almost entirely fatty) | 47 |
| Type B (Breasts are mainly fatty, with some scattered areas of dense tissue) | 192 |
| Type C (Breasts are a mixture of fatty and dense tissue) | 147 |
| Type D (Breasts are almost entirely dense) | 31 |
| Blank (No breast density category was recorded for the subjects) | 12 |
PDFs hosted by the registry, ClinicalTrials.gov.
Plan to share: No
Ran from Oct 2016 to primary completion in Jun 2018, 19 months.
Results were first posted in May 2025, 6 years 11 months after primary completion.
Of 189 industry-sponsored observational studies under Breast Neoplasms, half reached primary completion within 43 months of starting (the median), counting those still running; a quarter within 26 and three quarters within 70. This study's 19 months is below that.
Counting every sponsor, half of 1,380 studies reached it within 55 months; a quarter within 25 and three quarters within 126.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in May 2025. You cannot join it, but the record below documents what was studied.
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