Comparison of the Philips MicroDose Tomosynthesis System to 2D Digital Mammography

NCT ID: NCT02615509

Last Updated: 2020-05-08

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: NA
• Total Enrollment: 347 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-01-31
• Study Completion Date: 2018-02-20

Brief Summary

The primary objective of this study is to compare the safety and clinical performance of the Philips MicroDose Tomosynthesis system images and images from FFDM systems.

Detailed Description

The study will be performed in two phases: Image Accrual and Image Reading.

Approximately 800 women who fulfill all inclusion and exclusion criteria will be enrolled in chronological order from up to 3 different US sites with one study investigator for each site. Two cohorts of patients will be enrolled (i.e., Biopsy and Screening Cohorts). Paired sets of a standard 4-view exam will be collected both from Philips Tomosynthesis system (Tomosynthesis and synthetic 2D images) and a FDA-cleared FFDM system. All enrolled cases will be quality controlled for completeness of image and patient information.

The reading portion of the study will include approximately 300 normal cases (including some cases determined to be normal after call back after screening mammography), 65 cancer cases, and 40 biopsy proven benign cases.

The primary objective of the study is to compare the safety and clinical performance of the Philips MicroDose Tomosynthesis system (Tomosynthesis and synthetic 2D) images to conventional 2D mammography images (FFDM).

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: SCREENING
• Blinding Strategy: NONE

Study Groups

Imaging on experimental tomo device

Women will have a bilateral two-view mammogram (a total of four images) with the Philips MicroDose Tomosynthesis system and a bilateral two-view mammogram (a total of four images) with an FFDM system. The order of this will be randomised.

After collecting the cases together with ground truth a readers study will be performed.

Group Type: OTHER

Imaging on experimental tomo device

Intervention Type: RADIATION

The system used for imaging in the experimental arm is the Philips MicroDose tomography system. The system used for imaging in the active comparator is a standard FFDM system

Interventions

Imaging on experimental tomo device

The system used for imaging in the experimental arm is the Philips MicroDose tomography system. The system used for imaging in the active comparator is a standard FFDM system

Intervention Type: RADIATION

Eligibility Criteria

Inclusion Criteria

• Patient is female and at least 40 years of age
• No contraindication for routine bilateral mammography

Screening Cohort

• Patient presents for a routine screening mammogram Biopsy Cohort
• Patient is scheduled for a biopsy
• Patient has a screening detected abnormality

Exclusion Criteria

• Patient is pregnant or believes she may be pregnant; OR,
• Patient is breast feeding; OR
• Patient is unable or unwilling to give informed consent, including consent to reuse data for future research; OR,
• Patient has breast implants; OR
• Patient has previous surgical biopsy; OR
• Patient has previous breast cancer; OR
• Patient presented to screening with clinical symptoms (e.g. palpable lump, nipple discharge, nipple retraction, skin irritation or dimpling)

• Minimum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Philips Digital Mammography Sweden AB

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Etta Pisano, PhD

Role: PRINCIPAL_INVESTIGATOR

Beth Israel Deaconess Medical Center

Locations

University of Alabama at Birmingham

Birmingham, Alabama, United States

Countries

United States

Provided Documents

Document Type: Study Protocol and Statistical Analysis Plan

View Document

Other Identifiers

9RWH8K

Identifier Type: -

Identifier Source: org_study_id