Clinical trial NCT02615509: Comparison of the Philips MicroDose Tomosynthesis System to 2D Digital Mammography
Official title: Comparison of the Philips MicroDose Tomosynthesis System to 2D Digital Mammography
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: NA
Conditions: Breast Cancer
Keywords: Mammography
Tomosynthesis
Lead sponsor: Philips Digital Mammography Sweden AB
Sponsor class: INDUSTRY
First posted: 2015-11-26
Enrollment: 347
Sex: FEMALE
Minimum age (years): 40
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: SCREENING

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).

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)

Primary outcomes:
measure: 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.
timeFrame: Up to approximately 4 weeks.
Secondary outcomes:
measure: Compare Average Glandular Dose Between FDDM and Philips Tomosynthesis System
timeFrame: Nine months image accrual
measure: Compare Non-cancer Recall Rates Between FDDM and Philips Tomosynthesis System.
timeFrame: Nine months image accrual
measure: 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.
timeFrame: One year follow up will be performed on negative patients
measure: 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.
timeFrame: One year follow up will be performed on negative patients
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham
state: Alabama
Study officials:
affiliation: Beth Israel Deaconess Medical Center
name: Etta Pisano, PhD
role: PRINCIPAL_INVESTIGATOR
References: