Comparison of CE-DBT and MRI in Patients With Known Breast Lesions

NCT05754749 | Recruiting Early Phase 1 DMC FDA Drug

• 1 other identifier: LCCC2139
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this pilot study is to compare radiologist confidence level in evaluating patients with known breast lesions between contrast enhanced digital breast tomosynthesis (CE- DBT) and contrast enhanced dynamic magnetic resonance imaging (CE-MRI) acquired as a part of a standard clinical workup.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Reader confidence in identifying lesions on CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)

  To compare (using a reader study) the reader confidence in identifying lesions on CE-DBT to the reader confidence in identifying lesions on contrast enhanced dynamic breast MRI.

  Calculated once all imaging is complete [Anticipated 1.5 years]

Secondary Outcomes (6)

• Contrast enhancement curves of CE-DBT compared to conventional MRI (arbitrary units)

  Calculated once all imaging is complete [Anticipated 1.5 years]

• Diagnostic accuracy of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)

  Calculated once all imaging is complete [Anticipated 1.5 years]

• Sensitivity of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)

  Calculated once all imaging is complete [Anticipated 1.5 years]

• Specificity of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)

  Calculated once all imaging is complete [Anticipated 1.5 years]

• Positivity predictive value of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)

  Calculated once all imaging is complete [Anticipated 1.5 years]

Study Arms (1)

Contrast-enhanced digital breast tomosynthesis (CE-DBT)

EXPERIMENTAL

Participants with known breast lesions will be imaged using contrast-enhanced digital breast tomosynthesis (CE-DBT) with Iohexol 350 mg I/mL.

Drug: Iohexol 350 Mg/mL Injectable Solution

Interventions

Iohexol 350 Mg/mL Injectable Solution DRUG

Participants will be scanned with the digital breast tomosynthesis (DBT) system before and after the intravenous administration of iodinated contrast agent, iohexol 350mg I/mL at a dose of 1.5 mL/kg body weight. Images will be acquired of the breast of interest prior to the administration of contrast, followed by at approximately 2 minutes and 5 minutes after administration. For the purposes of this study, imaging will focus on a single breast to simplify data acquisition.

Also known as: Contrast- enhanced digital breast tomosynthesis (CE-DBT)

Contrast-enhanced digital breast tomosynthesis (CE-DBT)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women at least 18 years old
• Planned or received conventional breast MRI at UNC Hospitals within 3 months prior to or after the research scan
• Suspected breast lesion based on prior imaging (BIRADS 4 or greater)
• Able to provide written informed consent

You may not qualify if:

• Severe untreatable claustrophobia
• Implanted metallic devices, parts, vascular clips, or other foreign bodies (including breast implants)
• Known hypersensitivity to iodinated contrast agent or to any component of iodinated contrast refractory to standard medications (antihistamines, steroids)
• Impaired kidney function (serum creatinine level \> 1.8 mg/dl or a glomerular filtration rate \< 60 as approximated using serum creatinine levels within the last 30 days prior to the research scan) unless anuric and on dialysis
• Any woman who is pregnant or has reason to believe she is pregnant (the possibility of pregnancy has to be excluded by negative urine β-HCG results, obtained within 24 hours prior to the research scan, or on the basis of patient history, as defined by the UNC IRB SOP 4801)

Sponsors & Collaborators

• UNC Lineberger Comprehensive Cancer Center: lead

Study Sites (1)

University of North Carolina at Chapel Hill

Chapel Hill, North Carolina, 27599, United States

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Iohexol

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Triiodobenzoic Acids; Iodobenzoates; Benzoates; Acids, Carbocyclic; Carboxylic Acids; Organic Chemicals; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Study Officials

• Rachel Hitt, MD

  University of North Carolina, Chapel Hill

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Carly Sronce, BSN, RN-BC

CONTACT

919-966-3262; carly_sronce@med.unc.edu

Doreen Steed, R.T.(R)(M)

CONTACT

919-966-0188; doreen_steed@med.unc.edu

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 21, 2023
• First Posted: March 6, 2023
• Study Start: March 13, 2023
• Primary Completion (Estimated): August 22, 2026
• Study Completion (Estimated): August 22, 2026
• Last Updated: September 25, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 9 to 36 months following publication
• Access Criteria: The investigator who proposes to use the data has approval from an IRB, IEC, or REB, as applicable, and an executed data use/sharing agreement with UNC.

Locations

US (1)