Clinical trial NCT03611543: Evaluating Image Quality and Comfort of an Investigational Curved Paddle Compared to a Standard Paddle
Official title: Evaluating Image Quality and Comfort of an Investigational Curved Paddle Compared to a Standard Paddle
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Keywords: Breast Cancer
Tomosynthesis
3D Mammogram
Diagnostic Mammogram
Lead sponsor: Hologic, Inc.
Sponsor class: INDUSTRY
First posted: 2018-08-02
Enrollment: 443
Sex: FEMALE
Minimum age (years): 25
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_ONLY
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Women participating in the study will present for a screening or diagnostic imaging breast exam.

Brief 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 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.

Eligibility criteria: 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

Primary outcomes:
measure: Subject Comfort
timeFrame: 1 day (Day of procedure, No follow-up)
Secondary outcomes:
measure: Breast Tissue Coverage
timeFrame: 1 Day (Day of procedure, No Follow-up)
measure: Overall Determination of Image Quality
timeFrame: 1 day (Day of procedure, No Follow-up)
Other outcomes:
Locations:
city: Stamford
country: United States
facility: Stamford Hospital
state: Connecticut
city: Rochester
country: United States
facility: Elizabeth Wende Breast Clinic
state: New York
city: Addison
country: United States
facility: Solis Mammagroaphy
state: Texas
city: Houston
country: United States
facility: TOPS Comprehensive Breast Center
state: Texas
Study officials:
affiliation: Hologic, Inc.
name: Muhammad Waqas
role: STUDY_DIRECTOR
References: