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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02615509
• Other study ID #: 9RWH8K
• Status: Terminated
• Phase: N/A
• Start date: January 2016
• Est. completion date: February 20, 2018

Study information

• Verified date: April 2020
• Source: Philips Digital Mammography Sweden AB
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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).

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 347
• Est. completion date: February 20, 2018
• Est. primary completion date: February 20, 2018
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 40 Years and older

Eligibility

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)

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Radiation:
• 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

Locations

Country	Name	City	State
United States	University of Alabama at Birmingham	Birmingham	Alabama

Sponsors (1)

Lead Sponsor	Collaborator
Philips Digital Mammography Sweden AB

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Compare Average Glandular Dose Between FDDM and Philips Tomosynthesis System		Nine months image accrual
Secondary	Compare Non-cancer Recall Rates Between FDDM and Philips Tomosynthesis System.		Nine months image accrual
Secondary	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
Secondary	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