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Diagnostic Scans for Breast Cancer

Phase < 1
Recruiting
Led By Rachel Hitt, MD
Research Sponsored by UNC Lineberger Comprehensive Cancer Center
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up calculated once all imaging is complete [anticipated 1.5 years]
Awards & highlights
No Placebo-Only Group

Summary

This trial will compare two scans (CE-DBT & CE-MRI) to see which is better at finding breast lesions in patients.

Who is the study for?
This trial is for women aged 18 or older with suspected breast lesions (BIRADS 4+), who have had or will have a conventional breast MRI at UNC Hospitals within a three-month window around the research scan. Participants must be able to consent in writing and not be pregnant, as confirmed by tests or patient history.
What is being tested?
The study aims to compare radiologist confidence when evaluating known breast lesions using two imaging techniques: contrast enhanced digital breast tomosynthesis (CE-DBT) and contrast enhanced dynamic magnetic resonance imaging (CE-MRI).
What are the potential side effects?
Potential side effects may include allergic reactions to the iodinated contrast agent used in CE-DBT, such as skin rashes or more severe responses that could require medication like antihistamines or steroids.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~calculated once all imaging is complete [anticipated 1.5 years]
This trial's timeline: 3 weeks for screening, Varies for treatment, and calculated once all imaging is complete [anticipated 1.5 years] for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Reader confidence in identifying lesions on CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)
Secondary study objectives
Contrast enhancement curves of CE-DBT compared to conventional MRI (arbitrary units)
Diagnostic accuracy of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)
Positivity predictive value of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)
+3 more

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups
Experimental Treatment
Group I: Contrast-enhanced digital breast tomosynthesis (CE-DBT)Experimental Treatment1 Intervention
Participants with known breast lesions will be imaged using contrast-enhanced digital breast tomosynthesis (CE-DBT) with Iohexol 350 mg I/mL.

Find a Location

Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
365 Previous Clinical Trials
92,700 Total Patients Enrolled
52 Trials studying Breast Cancer
28,086 Patients Enrolled for Breast Cancer
Rachel Hitt, MDPrincipal InvestigatorUniversity of North Carolina, Chapel Hill

Media Library

Contrast-enhanced digital breast tomosynthesis (CE-DBT) Clinical Trial Eligibility Overview. Trial Name: NCT05754749 — Phase < 1
Breast Cancer Research Study Groups: Contrast-enhanced digital breast tomosynthesis (CE-DBT)
Breast Cancer Clinical Trial 2023: Contrast-enhanced digital breast tomosynthesis (CE-DBT) Highlights & Side Effects. Trial Name: NCT05754749 — Phase < 1
Contrast-enhanced digital breast tomosynthesis (CE-DBT) 2023 Treatment Timeline for Medical Study. Trial Name: NCT05754749 — Phase < 1
~5 spots leftby Aug 2025
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