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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
Must not have
Breasts too large to allow for adequate positioning for the DBT examination
Group B only: Patients with FFDM taken at screening who are unwilling or unable to submit images to ACRIN
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 1 year
Awards & highlights

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.
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.
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 below
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I am a woman aged 25 or older.
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I have never had breast cancer.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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My breast size prevents proper positioning for a DBT scan.
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I cannot or will not send my mammogram images for review.
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I cannot or do not want to undergo mammography due to discomfort.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~1 year
This trial's timeline: 3 weeks for screening, Varies for treatment, and 1 year for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Primary Aim: Recall Rates
Secondary study objectives
Secondary Aim: Comparison of Views
Secondary Aim: Lesion-Type Characterization
Secondary Aim: Radiation Dose
+2 more

Trial 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.

Find a Location

Who is running the clinical trial?

American College of Radiology Imaging NetworkLead Sponsor
39 Previous Clinical Trials
465,410 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

Screening Tomosynthesis (Imaging) Clinical Trial Eligibility Overview. Trial Name: NCT01236781 — Phase 2 & 3
Breast Cancer Research Study Groups: Group A: Screening, Group B: Diagnostic Enriched Population
Breast Cancer Clinical Trial 2023: Screening Tomosynthesis Highlights & Side Effects. Trial Name: NCT01236781 — Phase 2 & 3
Screening Tomosynthesis (Imaging) 2023 Treatment Timeline for Medical Study. Trial Name: NCT01236781 — Phase 2 & 3
~37 spots leftby Oct 2025
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