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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT00942396
• Other study ID #: TK01007
• Status: Withdrawn
• Phase: Phase 3
• First received: July 7, 2009
• Last updated: June 7, 2011
• Start date: April 2008
• Est. completion date: March 2011

Study information

• Verified date: June 2011
• Source: Planmed Oy
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

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 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 250
• Est. completion date: March 2011
• Est. primary completion date: March 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 40 Years to 85 Years

Eligibility

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 -

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?

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

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

Study Design

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer

Intervention

Device:
• Full Field Digital Mammogram (Planmed Sophie Nuance)
Full Field Digital Mammogram

Locations

Country	Name	City	State
United States	The Rose	Houston	Texas
United States	Mroz-Baier Breast Care Clinic	Memphis	Tennessee

Sponsors (1)

Lead Sponsor	Collaborator
Planmed Oy

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Area under ROC curve based on subjects' maximum POM scores; sensitivity based on subjects' maximum BI-RADS scores with 4 or higher as positive for cancer; and specificity based on subjects maximum BI-RADS scores with 4 or higher as positive for cancer		Approximately one year after completion of study.	No
Secondary	area under the ROC curve based on the maximum POM score per subject-breast		Approximately one year after completion of study.	No
Secondary	area under the ROC curve based on the POM scores from the ten regions of a subject's breasts;		Approximately one year after completion of study.	No
Secondary	sensitivity based on subjects' maximum BI-RADS scores using a cut-point of 3 or higher as positive for cancer;		Approximately one year after completion of study.	No
Secondary	specificity based on subjects' maximum BI-RADS scores using a cut-point of 3 or higher as positive for cancer;		Approximately one year after completion of study.	No
Secondary	Sensitivity and specificity based on the maximum BI-RADS scores per subject-breast using 4 or higher for positive; and sensitivity and specificity based on the maximum BI-RADS scores per subject-breast using 3 or higher for positive.		Approximately one year after completion of study.	No
Secondary	Feature Analysis Study; side by side assessment of SFM and FFDM images and comparison of quality features: lesion conspicuity, tissue visibility at chest wall, tissue visibility at skin line, axillary details (MLO), overall contrast, overall sharpness		Approximately one year after completion of study.	No
Secondary	Adverse event assessment		Approximately 24 hours after completion of FFDM	Yes