Breast CancerNCT03611543
Evaluating Image Quality and Comfort of an Investigational Curved Paddle Compared to a Standard Paddle
An observational study of Breast Cancer, run by Hologic, Inc. at 4 sites in United States.
Trial summary
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… Read more about this study
- Who is it for?
- Ages 25 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Investigational Curved Paddle
- Type of treatment
- Medical device
- How many people
- 443 participants
- Where
- 4 sitesUnited States
- Study dates
- 20 Oct 2016to 18 Jun 2018
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 25 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women participating in the study will present for a screening or diagnostic imaging breast exam.
Who may be able to join
- Subject is female of any race and ethnicity
- Screening Subject is at least 40 years old, Diagnostic subjects are at least 25 years old
- Subject will be referred for a screening or a diagnostic work-up with tomosynthesis as part of the exam
Who cannot join
- Subjects who are pregnant or who think they may be pregnant
- Subjects lactating or presenting with discharge
- Women too large for the detector
- Subjects who cannot give informed consent
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Solis Mammagroaphy
Addison, Texas, 75001
TOPS Comprehensive Breast Center
Houston, Texas, 77090
Elizabeth Wende Breast Clinic
Rochester, New York, 14620
Stamford Hospital
Stamford, Connecticut, 06902
About this study
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.
Read the detailed description
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.
- Conditions
- Breast Cancer
- Being tested
- Standard of Care Flat Paddle, Investigational Curved Paddle
- Keywords
- Breast Cancer, Tomosynthesis, 3D Mammogram, Diagnostic Mammogram
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care Flat PaddleDevice
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.
Investigational Curved PaddleDevice
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.
| Study group | Role | What they receive |
|---|---|---|
| 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'. Receives: Device: Standard of Care Flat Paddle | |
| 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'. Receives: Device: Investigational Curved Paddle |
What is being measured
The primary outcome is the main question the study is designed to answer.
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'.
Measured: 1 day (Day of procedure, No follow-up)
Secondary outcomes (2)
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.
Measured: 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.
Measured: 1 day (Day of procedure, No Follow-up)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Aug 2018
- Study start20 Oct 2016
- Primary completion18 Jun 2018
- Study completion18 Jun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 443 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hologic, Inc.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Muhammad Waqas, Study director, Hologic, Inc.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03611543
- Sponsor's protocol ID
- 16-03
- Status last verified
- May 2025
- First submitted
- 20 Oct 2016
- Last updated
- 21 May 2025
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating Image Quality and Comfort of an Investigational Curved Paddle Compared to a Standard Paddle
- ClinicalTrials.gov ID
- NCT03611543
- Acronym / sponsor ID
- 16-03
- Conditions
- Breast Cancer
- Keywords
- Breast Cancer, Tomosynthesis, 3D Mammogram, Diagnostic Mammogram
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 443 participants (actual)
- Lead sponsor
- Hologic, Inc.Industry (pharma, biotech, devices)
- Study start
- 20 Oct 2016 (actual)
- Primary completion
- 18 Jun 2018 (actual)
- Study completion
- 18 Jun 2018 (actual)
- First posted
- 2 Aug 2018 (actual)
- Results
- Posted 21 May 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| STANDARD OF CARE | – | Device: Standard of Care Flat PaddleAll 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'. |
| INVESTIGATIONAL | – | Device: Investigational Curved PaddleAll 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'. |
Who may qualify
- Ages
- 25 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women participating in the study will present for a screening or diagnostic imaging breast exam.
Key inclusion criteria (3 listed)
- Subject is female of any race and ethnicity
- Screening Subject is at least 40 years old, Diagnostic subjects are at least 25 years old
- Subject will be referred for a screening or a diagnostic work-up with tomosynthesis as part of the exam
Key exclusion criteria (4 listed)
- Subjects who are pregnant or who think they may be pregnant
- Subjects lactating or presenting with discharge
- Women too large for the detector
- Subjects who cannot give informed consent
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Standard of Care Flat PaddleX-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. | Device | STANDARD OF CARE |
| Investigational Curved PaddleX-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. | Device | INVESTIGATIONAL |
Primary outcome
Subject Comfort
Time frame: 1 day (Day of procedure, No follow-up)
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'.
2 secondary outcomes
Breast Tissue Coverage
Time frame: 1 Day (Day of procedure, No Follow-up)
Overall Determination of Image Quality
Time frame: 1 day (Day of procedure, No Follow-up)
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 May 2025.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Muhammad Waqas study director
Hologic, Inc.
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Hologic, Inc. at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 21 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Yes. Results are posted in the registry (first posted 21 May 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Subject Comfort (time frame: 1 day (Day of procedure, No follow-up)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 May 2025.