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

Withdrawn before enrolling · Phase 3

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID: NCT00942396
Run by: Planmed Oy
People needed: 250
Starts: 2008-04-01
Expected to finish: 2011-03-01
Last updated by the study team: 2011-06-09

Who can join

Age: 40 and older, up to 85. Sex: female. Healthy volunteers: accepted.

You may qualify if…

Subject is 40 years of age or older
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)
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
Subject will provide prospective, written informed consent
Subject is considered capable of complying with study procedures including a willingness to return for a one-year follow-up exam -

You may not qualify if…

Subject is pregnant or possibly pregnant or planning pregnancy within the next 15 months
Subject has undergone a breast augmentation or breast implant? Has subject had any of the following breast procedures?
Fine needle or cyst aspiration NOT Eligible if within past year Biopsy Not Eligible if within past year Lumpectomy (for breast cancer) Mastectomy (for breast cancer) Radiation therapy Breast reconstruction Breast reduction Not Eligible if within past year
Subject has had an invasive breast procedure or operation within the past year
Subject has significant existing breast trauma
Subject has a history of breast cancer treated with operation or radiation
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

Where it is running

Mroz-Baier Breast Care Clinic — Memphis, Tennessee, United States
The Rose — Houston, Texas, United States

Full record on ClinicalTrials.gov

Trial information comes from ClinicalTrials.gov and is refreshed daily. TrialsForMe does not provide medical care and does not run the studies it lists.