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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03611543
• Other study ID #: 16-03
• Status: Completed
• Start date: October 20, 2016
• Est. completion date: June 18, 2018

Study information

• Verified date: May 2020
• Source: Hologic, Inc.
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 515
• Est. completion date: June 18, 2018
• Est. primary completion date: June 18, 2018
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 25 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Device:
• New investigational curved paddle
X-ray imaging of breast tissue

Locations

Country	Name	City	State
United States	Solis Mammagroaphy	Addison	Texas
United States	University Hospitals Cleveland Medical Center	Cleveland	Ohio
United States	TOPS Comprehensive Breast Center	Houston	Texas
United States	Elizabeth Wende Breast Clinic	Rochester	New York
United States	Stamford Hospital	Stamford	Connecticut

Sponsors (1)

Lead Sponsor	Collaborator
Hologic, Inc.

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Patient Comfort	Score of 1-10 on Universal Pain Assessment Tool	Day of Procedure (No Follow-up)
Secondary	Tissue Volume	Acceptable/Non-Acceptable determination on tissue coverage	Day of Procedure (No Follow-up)
Secondary	Image quality	Acceptable/Non-Acceptable determination on overall image quality	Day of Procedure (No Follow-up)