- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00763100
Efficacy of Tomosynthesis in the BIRADS 3 Population (BIRADS)
The Efficacy of Tomosynthesis in the BIRADS 3 Population Including Surveillance of Patients in the Treatment or Post-Treatment for Breast Cancer
Study Overview
Status
Conditions
Study Type
Enrollment (Anticipated)
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Three groups of patients will be enrolled:
Group 1 will enroll patients that have been categorized as a BIRADS 3 on the basis of screening and diagnostic conventional imaging work-up.
Group II will enroll patients that have been categorized as a BIRADS 3 for surveillance imaging because they have undergone breast conservation therapy for breast cancer.
Group III will enroll patients that have been categorized as a BIRADS 3 for surveillance imaging because they are currently undergoing primary systemic therapy.
Description
Inclusion Criteria:
GROUP 1
- female of any race and ethnicity
- 35 years or older
- after routine and diagnostic imaging, subject is categorized as a BI-RADS 3 and will undergo study imaging within 30 days of routine or diagnostic imaging.
- subject is returning for surveillance imaging after a categorization of a BI-RADS 3 and will undergo study imaging within 30 days of surveillance imaging GROUP 2
- female of any race and ethnicity
- 26 years or older
- subject has completed cancer treatment and is currently categorized as a BI-RADS 3 for surveillance imaging
- subject will undergo study imaging within 30 days of surveillance imaging GROUP 3
- female of any race and ethnicity
- 26 years or older
- subject is currently undergoing cancer treatment and is currently categorized as a BI-RADS 3 for surveillance imaging OR
- subject will undergo study imaging within 30 days of surveillance imaging
Exclusion Criteria:
- GROUP 1, 2 and 3
- subjects unable or unwilling to participate
- subjects who are unable or unwilling to tolerate compression
- subjects who are pregnant or who think they may be pregnant
- subjects who are breastfeeding
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Breast cancer
Patients in treatment or post-treatment for breast cancer
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
to see if Breast Tomosynthesis, a three-dimensional (3D) imaging study is more accurate than standard mammography (a two-dimensional (2D) study).
Time Frame: 5 years
|
5 years
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Joanne Trapeni, DO, WellSpan Health
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0708023
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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