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Completed

NCT Number: NCT03611543

Evaluating Image Quality and Comfort of an Investigational Curved Paddle Compared to a Standard Paddle

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.

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Age range

25 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Stamford Hospital, Stamford, Connecticut, United States

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About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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.

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.

Primary outcomes

  1. 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'.

Secondary outcomes

  1. Breast Tissue Coverage

    Time frame: 1 Day (Day of procedure, No Follow-up)

    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.

  2. Overall Determination of Image Quality

    Time frame: 1 day (Day of procedure, No Follow-up)

    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.

Sponsors and collaborators

Lead sponsor

Hologic, Inc.

Industry

Registry information

Important dates

Study start
2016
Primary completion
2018
Study completion
2018
First posted
Aug 2, 2018
Registry last updated
May 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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