Status:
WITHDRAWN
Study to Compare the Diagnostic Accuracy of Nuance Full-Field Digital Mammography to Screen-Film Mammography
Lead Sponsor:
Planmed Oy
Conditions:
Breast Cancer
Eligibility:
FEMALE
40-85 years
Phase:
PHASE3
Brief Summary
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.
Detailed Description
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 ...
Eligibility Criteria
Inclusion
- 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 -
Exclusion
- 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
Key Trial Info
Start Date :
April 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
March 1 2011
Estimated Enrollment :
250 Patients enrolled
Trial Details
Trial ID
NCT00942396
Start Date
April 1 2008
End Date
March 1 2011
Last Update
June 9 2011
Active Locations (2)
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1
Mroz-Baier Breast Care Clinic
Memphis, Tennessee, United States, 38119
2
The Rose
Houston, Texas, United States, 77034