Study to Compare the Diagnostic Accuracy of Nuance Full-Field Digital Mammography to Screen-Film Mammography
NCT ID: NCT00942396
Last Updated: 2011-06-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
WITHDRAWN
PHASE3
250 participants
INTERVENTIONAL
2008-04-30
2011-03-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Comparison of Full-Field Digital Mammography With Digital Breast Tomography for Screening Call-Back Rates
NCT01236781
Image Evaluation of Philips Philips MammoDiagnost DR Full Field Digital Mammography System (FFDM)
NCT00999596
Fujifilm DBT Plus S-View Versus FFDM Alone in the Detection of Breast Cancer - A Pivotal Study
NCT03501693
Breast Density and the Role of Preoperative Mammography, Ultrasound, Elastography and MRI
NCT00695968
Pilot 3D Mammography Reader Study to Assess Breast Cancer Detection in 3D Versus 2D Digital Mammography
NCT01928992
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
NON_RANDOMIZED
SINGLE_GROUP
DIAGNOSTIC
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
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
Full Field Digital Mammogram (Planmed Sophie Nuance)
Full Field Digital Mammogram
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Full Field Digital Mammogram (Planmed Sophie Nuance)
Full Field Digital Mammogram
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
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
40 Years
85 Years
FEMALE
Yes
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Planmed Oy
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Planmed OY
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Sami Tohka, PhD
Role: STUDY_DIRECTOR
Planmed Oy
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Mroz-Baier Breast Care Clinic
Memphis, Tennessee, United States
The Rose
Houston, Texas, United States
Countries
Review the countries where the study has at least one active or historical site.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
TK01007
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.