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

NCT02615509 | Terminated Results

• 1 other identifier: 9RWH8K
• Study Type: interventional
• Target: 347
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Keywords

Mammography; Tomosynthesis

Outcome Measures

Primary Outcomes (1)

• To Compare the Clinical Performance of the Philips MicroDose Tomosynthesis System Images to Conventional 2D Mammography Images. Clinical Performance Will be Based on the Area Under the Receiver Operating Characteristics Curve.

  Due to study termination the conventional images where not taken and it was not possible to calculate the Area under the Receiver Operating Characteristics Curve. Instead we are reporting the biopsy results from the Philips MicroDose Tomosynthesis system. The time frame from examination to biopsy is documented as an estimate based on the relative urgency to detect potential tumors.

  Up to approximately 4 weeks.

Secondary Outcomes (4)

• Compare Average Glandular Dose Between FDDM and Philips Tomosynthesis System

  Nine months image accrual

• Compare Non-cancer Recall Rates Between FDDM and Philips Tomosynthesis System.

  Nine months image accrual

• Compare Sensitivity Between FDDM and Philips Tomosynthesis System, Sensitivity Will be Estimated for Each Reader as the Proportion of Cancer Cases With Per-case BI-RADS Category 4 or Higher.

  One year follow up will be performed on negative patients

• Compare Specificity Between FDDM and Philips Tomosynthesis System. Specificity Will be Estimated by Reader as the Proportion of Non-cancer Cases With Per-case BI-RADS Category Less Than 4.

  One year follow up will be performed on negative patients

Study Arms (1)

Imaging on experimental tomo device

OTHER

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.

Radiation: Imaging on experimental tomo device

Interventions

Imaging on experimental tomo device 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

Imaging on experimental tomo device

Eligibility Criteria

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

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Philips Digital Mammography Sweden AB: lead

Study Sites (1)

University of Alabama at Birmingham

Birmingham, Alabama, 35294-6830, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Daniel Stenströmer
• Organization: Philips AB

daniel.stenstromer@philips.com

+46 708 303 767

Study Officials

• Etta Pisano, PhD

  Beth Israel Deaconess Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

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

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SCREENING
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 12, 2015
• First Posted: November 26, 2015
• Study Start: January 1, 2016
• Primary Completion: February 20, 2018
• Study Completion: February 20, 2018
• Last Updated: May 8, 2020
• Results First Posted: May 8, 2020

Record last verified: 2020-04

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)