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This study has been withdrawn prior to enrollment.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:
Information provided by:
Planmed Oy
ClinicalTrials.gov Identifier:
NCT00942396
First received: July 7, 2009
Last updated: June 7, 2011
Last verified: June 2011
  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:
  • mammography
  • digital mammography

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:

  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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 August 01, 2014