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WITHDRAWNPhase 3NCT00942396

Study to Compare the Diagnostic Accuracy of Nuance Full-Field Digital Mammography to Screen-Film Mammography

Evaluate the diagnostic accuracy of the Planmed Sophie Nuance Full Field Digital Mammography (FFDM) X-ray System compared to screen-film mammography (SFM) in the detection of breast cancer.

Lead sponsor: Planmed Oy•2 U.S. locations•View source on ClinicalTrials.gov

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Sponsors

Lead Sponsor

Planmed Oy

Objectives: 1) To establish the non-inferiority of the diagnostic accuracy of the Planmed Sophie Nuance Full Field Digital Mammography (FFDM) X-ray System compared to screen-film mammography (SFM) in the detection of breast cancer; and 2) To demonstrate in a comparative side-by-side feature analysis that interpretations based on the Planmed Sophie Nuance FFDM X-ray System are diagnostically non-inferior to SFM in the detection of breast cancer.

Age

40 - 85 years

Sex

FEMALE

Healthy Volunteers

Yes

Inclusion Criteria

•1. Subject is 40 years of age or older
•2. Subject is presenting for routine breasts cancer screening (Cohort I) OR Subject has one or both breasts scored 4 or 5 on the BI-RADS scale as a result of SFM either for routine breast cancer screening or for follow-up or diagnostic mammography (Cohort II)
•3. Subject's schedule permits the SFM and the FFDM to be performed no more than 30 days apart and with no intervention between the exams
•4. Subject will provide prospective, written informed consent
•5. Subject is considered capable of complying with study procedures including a willingness to return for a one-year follow-up exam -
•3. Subject has had an invasive breast procedure or operation within the past year
•4. Subject has significant existing breast trauma
•5. Subject has a history of breast cancer treated with operation or radiation
•6. Subject has any other condition or personal circumstance that, in the judgment of the investigator, might interfere with the collection of complete good quality data

Exclusion Criteria

•1. Subject is pregnant or possibly pregnant or planning pregnancy within the next 15 months
•2. Subject has undergone a breast augmentation or breast implant? Has subject had any of the following breast procedures?

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Data from ClinicalTrials.govLast updated on ClinicalTrials.gov: June 9, 2011Terms

Trial snapshot

StatusWITHDRAWN

PhasePHASE3

Enrollment250

Start dateApr 2008

Last updatedJun 9, 2011

Condition

Locations shown

Mroz-Baier Breast Care Clinic

Memphis, Tennessee

The Rose

Houston, Texas

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: June 9, 2011Data synced to Clareo: June 28, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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