Study to Compare the Diagnostic Accuracy of Nuance Full-Field Digital Mammography to Screen-Film Mammography
This study has been withdrawn prior to enrollment.
(FDA changed classification of device and no longer requires this type of clinical data)
Sponsor:
Planmed Oy
Information provided by:
Planmed Oy
ClinicalTrials.gov Identifier:
NCT00942396
First received: July 7, 2009
Last updated: June 7, 2011
Last verified: June 2011
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Purpose
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.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Device: Full Field Digital Mammogram (Planmed Sophie Nuance) |
Phase 3 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Safety/Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Diagnostic |
| Official Title: | Study to Compare the Diagnostic Accuracy of Nuance Full-Field Digital Mammography to Screen-Film Mammography |
Resource links provided by NLM:
Further study details as provided by Planmed Oy:
Primary Outcome Measures:
- 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 [ Time Frame: Approximately one year after completion of study. ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- area under the ROC curve based on the maximum POM score per subject-breast [ Time Frame: Approximately one year after completion of study. ] [ Designated as safety issue: No ]
- area under the ROC curve based on the POM scores from the ten regions of a subject's breasts; [ Time Frame: Approximately one year after completion of study. ] [ Designated as safety issue: No ]
- sensitivity based on subjects' maximum BI-RADS scores using a cut-point of 3 or higher as positive for cancer; [ Time Frame: Approximately one year after completion of study. ] [ Designated as safety issue: No ]
- specificity based on subjects' maximum BI-RADS scores using a cut-point of 3 or higher as positive for cancer; [ Time Frame: Approximately one year after completion of study. ] [ Designated as safety issue: No ]
- 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. [ Time Frame: Approximately one year after completion of study. ] [ Designated as safety issue: No ]
- 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 [ Time Frame: Approximately one year after completion of study. ] [ Designated as safety issue: No ]
- Adverse event assessment [ Time Frame: Approximately 24 hours after completion of FFDM ] [ Designated as safety issue: Yes ]
| Estimated Enrollment: | 250 |
| Study Start Date: | April 2008 |
| Estimated Study Completion Date: | March 2011 |
| Estimated Primary Completion Date: | March 2011 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Experimental: mammography
Women must be at least 40 years of age, presenting for routine breast cancer screening or presenting with 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
|
Device: Full Field Digital Mammogram (Planmed Sophie Nuance)
Full Field Digital Mammogram
Other Names:
|
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| Ages Eligible for Study: | 40 Years to 85 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | Yes |
Criteria
Inclusion Criteria:
- 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 Criteria:
- 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
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00942396
Locations
| United States, Tennessee | |
| Mroz-Baier Breast Care Clinic | |
| Memphis, Tennessee, United States, 38119 | |
| United States, Texas | |
| The Rose | |
| Houston, Texas, United States, 77034 | |
Sponsors and Collaborators
Planmed Oy
Investigators
| Study Director: | Sami Tohka, PhD | Planmed Oy |
More Information
No publications provided
| Responsible Party: | Chris Oldham/ Director of North American Sales, Planmed OY |
| ClinicalTrials.gov Identifier: | NCT00942396 History of Changes |
| Other Study ID Numbers: | TK01007 |
| Study First Received: | July 7, 2009 |
| Last Updated: | June 7, 2011 |
| Health Authority: | United States: Institutional Review Board |
Keywords provided by Planmed Oy:
|
Mammography |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases |
ClinicalTrials.gov processed this record on May 19, 2013