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Imaging
2D and 3D Breast Imaging for Breast Cancer Screening
Phase 2 & 3
Waitlist Available
Research Sponsored by American College of Radiology Imaging Network
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Women 25 years of age or older
No history of breast cancer
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights
Study Summary
This trial will compare the specificity of 2D mammography to a combination of 2D and 3D tomosynthesis imaging in breast cancer screening.
Who is the study for?
This trial is for women aged 25 or older without breast cancer history. Group A includes those scheduled for a screening mammogram and willing to consent. Group B involves women recalled for diagnostic testing after a recent mammogram showed possible issues. Participants must be able to complete imaging at the same facility and tolerate compression from mammography.Check my eligibility
What is being tested?
The study compares traditional digital mammograms (2-D) with combined 2-D and advanced 3-D tomosynthesis imaging, aiming to reduce unnecessary call-backs while maintaining cancer detection rates. It will optimize the number of views and sequence of images within safe radiation levels using Hologic units.See study design
What are the potential side effects?
There are generally no direct side effects from undergoing digital mammography or tomosynthesis as they are non-invasive imaging techniques. However, there may be discomfort due to breast compression during the procedure, and minimal exposure to radiation similar to standard X-rays.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am a woman aged 25 or older.
Select...
I have never had breast cancer.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 1 year
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Primary Aim: Recall Rates
Secondary outcome measures
Secondary Aim: Comparison of Views
Secondary Aim: Lesion-Type Characterization
Secondary Aim: Radiation Dose
+2 moreTrial Design
2Treatment groups
Experimental Treatment
Group I: Group B: Diagnostic Enriched PopulationExperimental Treatment1 Intervention
Approximately 50 asymptomatic women with no history of breast cancer who have been informed of positive (abnormal) findings from a recent (within 30 days) FFDM screening will be recruited to Group B prior to their diagnostic imaging (e.g., diagnostic FFDM and/or ultrasound and/or other).
Group II: Group A: ScreeningExperimental Treatment1 Intervention
Group A comprises 500 asymptomatic women with no history of breast cancer who are scheduled for routine screening of the breasts with FFDM.
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Who is running the clinical trial?
American College of Radiology Imaging NetworkLead Sponsor
39 Previous Clinical Trials
466,325 Total Patients Enrolled
8 Trials studying Breast Cancer
51,457 Patients Enrolled for Breast Cancer
Pennsylvania Department of HealthOTHER_GOV
41 Previous Clinical Trials
997,845 Total Patients Enrolled
Emily F. Conant, MDStudy ChairHospital of University of Pennsylvania
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- My breast size prevents proper positioning for a DBT scan.I am a woman aged 25 or older.I am in Group A, have no breast symptoms, and am scheduled for a mammogram.I was called back for more tests after a recent mammogram showed I might have breast cancer.I have never had breast cancer.I cannot or will not send my mammogram images for review.You have breast implants.I cannot or do not want to undergo mammography due to discomfort.
Research Study Groups:
This trial has the following groups:- Group 1: Group A: Screening
- Group 2: Group B: Diagnostic Enriched Population
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are people with the required medical history still able to sign up for this research project?
"The trial in question is not recruiting patients at this time. It was originally posted on December 1st 2010, and the last update was March 13th 2012. However, there are 2369 other trials that are currently looking for participants."
Answered by AI
Who else is applying?
What site did they apply to?
Hospital of University of Pennsylvania
What portion of applicants met pre-screening criteria?
Met criteria
How many prior treatments have patients received?
0
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