Image Quality Assessment for Screening and Diagnostic Mammography

NCT02786004 | Completed Results

• 1 other identifier: 124.03-2015-GES-0004
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

This study is being conducted to determine the image quality of images using a new investigational medical imaging device.

Conditions

Breast Health

Outcome Measures

Primary Outcomes (1)

• Number of Participants With Acceptable Overall Clinical Image Quality

  Overall clinical image quality was assessed by Mammography Quality Standards Act (MQSA) qualified radiologists ("readers"). Readers documented acceptability of FFDM and DBT image quality and image characteristics, as set for in the Guidance for Industry and FDA Staff - Class II Special Controls Guidance Document: Full Field Digital Mammography System (2012).

  At enrollment completion approximately 3 months post initiation

Secondary Outcomes (1)

• Number of Subjects Experiencing a Device Related Adverse Events, Serious Adverse Event, Unanticipated Device Effect, and Device Defects by Overall Occurrence.

  Through study completion, approximately 3 months

Study Arms (2)

Full Field Digital Mammography

EXPERIMENTAL

2-dimensional breast imaging

Device: Full Field Digital Mammography

Digital Breast Tomosynthesis

EXPERIMENTAL

3-dimensional breast imaging

Device: Digital Breast Tomosynthesis

Interventions

Full Field Digital Mammography DEVICE

Also known as: 2D Mammography

Full Field Digital Mammography

Digital Breast Tomosynthesis DEVICE

Also known as: DBT

Digital Breast Tomosynthesis

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Are women aged 40 years or older (≥40 years old);
• Have had a FFDM (Full Field Digital Mammography) or DBT (Digital Breast Tomosynthesis) breast imaging exam within 30 days prior to enrollment;
• Have breast sizes compatible with the dimensions of a 24x29 cm image detector without anatomical cut-off;
• Are able to walk without assistive devices;
• Are sterile; post-menopausal; or if of childbearing potential, have a negative pregnancy test or is willing to provide urine sample to confirm no pregnancy, within 30 days of imaging exam; and
• Are willing to provide written informed consent to participate.

You may not qualify if:

• Have been previously included in this study or are participating in another trial expected to interfere with study procedures or outcomes;
• Have a history of breast biopsy, lumpectomy or mastectomy, or reconstruction on either breast;
• Are currently lactating;
• Are currently undergoing radiotherapy or chemotherapy , or have a history of prior radiotherapy treatment on either breast; or

Sponsors & Collaborators

• GE Healthcare: lead

Study Sites (1)

Carolina Breast Imaging Specialist

Greenville, North Carolina, 27834, United States

Location

MeSH Terms

Interventions

Mammography

Intervention Hierarchy (Ancestors)

Radiography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Results Point of Contact

• Title: Beth Heckel
• Organization: GE Healthcare

beth.heckel@med.ge.com

262-312-7269

Study Officials

• Bruce Schroeder, MD

  Carolina Breast Imaging Specialists

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2016
• First Posted: May 30, 2016
• Study Start: February 1, 2016
• Primary Completion: May 1, 2016
• Study Completion: May 1, 2016
• Last Updated: November 7, 2018
• Results First Posted: July 21, 2017

Record last verified: 2018-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)