N/A N=107

Image Evaluation of Philips Philips MammoDiagnost DR Full Field Digital Mammography System (FFDM)

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00999596 ↗

Enrolled (actual)

107

Serious AEs

0.0%

Results posted

May 2012

Primary outcome: Primary: FFDM (Full Field Digital Mammography) Mammogram Scores — 12; 0 FFDM Mammogram set

Study Design & Population

Study type: Observational
Phase: N/A
Interventions: —
Age: Adult, Older Adult · 40+ yrs
Sex: Female
Sponsor: Philips Healthcare
Primary completion: Jan 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY FFDM (Full Field Digital Mammography) Mammogram Scores	12; 0	—

Summary

The purpose of this investigation, using hardcopy film, is to compare the accuracy of the Philips MammoDiagnost DR (FFDM device) and screen-film (SF) mammography in detection of breast cancer among women undergoing screening or diagnostic mammography. Per the new FDA Guidance document for FFDM, accuracy in comparison to Screen-film is no longer required.

Eligibility Criteria

Inclusion Criteria

Patient underwent or is scheduled to undergo a screening or diagnostic mammogram examination (right and left craniocaudal and mediolateral oblique with or without special views) at one of the acquisition centers during the course of this research study.
At least 40 years of age
Provides written informed consent indicating willingness to participate in this research study prior to performance of the Philips FFDM mammogram
Meets none of the exclusion criteria

Exclusion Criteria

Presence of a breast implant,
Patients undergoing a unilateral mammogram or an incomplete SF mammogram
had previously undergone an excisional breast biopsy
Pregnant women or patients who believe they may be pregnant

(f) Inmates (in accordance with 45 CFR 46.306)

(g) Patients who cannot, for any reason, undergo follow-up mammography examinations (where clinically indicated) at the participating institution

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00999596). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.