Clinical trial NCT00942396: Study to Compare the Diagnostic Accuracy of Nuance Full-Field Digital Mammography to Screen-Film Mammography
Official title: Study to Compare the Diagnostic Accuracy of Nuance Full-Field Digital Mammography to Screen-Film Mammography
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE3
Conditions: Breast Cancer
Keywords: Mammography
Lead sponsor: Planmed Oy
Sponsor class: INDUSTRY
First posted: 2009-07-20
Enrollment: 250
Sex: FEMALE
Minimum age (years): 40
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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 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.

Eligibility criteria: 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

Primary outcomes:
measure: 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
timeFrame: Approximately one year after completion of study.
Secondary outcomes:
measure: area under the ROC curve based on the maximum POM score per subject-breast
timeFrame: Approximately one year after completion of study.
measure: area under the ROC curve based on the POM scores from the ten regions of a subject's breasts;
timeFrame: Approximately one year after completion of study.
measure: sensitivity based on subjects' maximum BI-RADS scores using a cut-point of 3 or higher as positive for cancer;
timeFrame: Approximately one year after completion of study.
measure: specificity based on subjects' maximum BI-RADS scores using a cut-point of 3 or higher as positive for cancer;
timeFrame: Approximately one year after completion of study.
measure: 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.
timeFrame: Approximately one year after completion of study.
measure: 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
timeFrame: Approximately one year after completion of study.
measure: Adverse event assessment
timeFrame: Approximately 24 hours after completion of FFDM
Other outcomes:
Locations:
city: Memphis
country: United States
facility: Mroz-Baier Breast Care Clinic
state: Tennessee
city: Houston
country: United States
facility: The Rose
state: Texas
Study officials:
affiliation: Planmed Oy
name: Sami Tohka, PhD
role: STUDY_DIRECTOR
References: