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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

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.Check my eligibility
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).See study design
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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Reader confidence in identifying lesions on CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)
Secondary outcome measures
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

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.

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Who is running the clinical trial?

UNC Lineberger Comprehensive Cancer CenterLead Sponsor
354 Previous Clinical Trials
91,438 Total Patients Enrolled
51 Trials studying Breast Cancer
27,966 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
~2 spots leftby Oct 2024
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