Breast CancerEarly Phase 1NCT05754749
Comparison of CE-DBT and MRI in Patients With Known Breast Lesions
A Early Phase 1 study testing Iohexol 350 Mg/mL Injectable Solution in people with Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Iohexol 350 Mg/mL Injectable Solution
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 4 participants
- Where
- 1 siteUnited States
- Study dates
- 13 Mar 2023to 20 May 2026
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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)
Trial locations and contacts
1 site in 1 country.
United States1 site
University of North Carolina at Chapel Hill
Chapel Hill, North Carolina, 27599
About this study
Official title: Comparison of Contrast Enhanced Digital Breast Tomosynthesis and Magnetic Resonance Imaging in Patients With Known Breast Lesions
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.
Read the detailed description
This is a pilot study of CE-DBT scans to evaluate its utility relative to breast CE-MRI. Twenty women who have planned or received conventional breast MRI imaging at UNC Hospitals will be recruited for the study. Participants will be scanned with the DBT system after the administration of iodinated contrast agent. Images will be acquired prior to the administration of contrast, followed by at approximately 2 minutes and 5 minutes. For the purposes of this study, imaging will focus on a single breast to simplify data acquisition.
- Conditions
- Breast Cancer
- Being tested
- Iohexol 350 Mg/mL Injectable Solution
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iohexol 350 Mg/mL Injectable SolutionDrug
Also called Contrast- enhanced digital breast tomosynthesis (CE-DBT)
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Iohexol 350 Mg/mL Injectable Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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)
To compare (using a reader study) the contrast enhancement curves of CE-DBT to the contrast enhancement curves of contrast enhanced dynamic breast MRI in evaluation of known breast lesions for predicting malignancy.
Measured: Calculated once all imaging is complete [Anticipated 1.5 years]
Diagnostic accuracy of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)
To compare (using a reader study) the diagnostic accuracy of CE-DBT to the diagnostic accuracy of contrast enhanced dynamic breast MRI in evaluation of known breast lesions for predicting malignancy.
Measured: Calculated once all imaging is complete [Anticipated 1.5 years]
Sensitivity of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)
To compare (using a reader study) the sensitivity of CE-DBT to the sensitivity of contrast enhanced dynamic breast MRI in evaluation of known breast lesions for predicting malignancy.
Measured: Calculated once all imaging is complete [Anticipated 1.5 years]
Specificity of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)
To compare (using a reader study) the specificity of CE-DBT to the specificity of contrast enhanced dynamic breast MRI in evaluation of known breast lesions for predicting malignancy.
Measured: 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)
To compare (using a reader study) the positivity predictive value of CE-DBT to the positivity predictive value of contrast enhanced dynamic breast MRI in evaluation of known breast lesions for predicting malignancy.
Measured: Calculated once all imaging is complete [Anticipated 1.5 years]
Receiver Operating Characteristic (ROC) curves of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)
To compare (using a reader study) the ROC curves of CE-DBT to the ROC curves of contrast enhanced dynamic breast MRI in evaluation of known breast lesions for predicting malignancy.
Measured: Calculated once all imaging is complete [Anticipated 1.5 years]
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Mar 2023
- Study start13 Mar 2023
- Primary completion20 May 2026
- Study completion20 May 2026
Why it stopped: Funding unavailable
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by UNC Lineberger Comprehensive Cancer CenterThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 4 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNC Lineberger Comprehensive Cancer Center
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Rachel Hitt, MD, Principal investigator, University of North Carolina, Chapel Hill
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05754749
- Sponsor's protocol ID
- LCCC2139
- Status last verified
- Jul 2026
- First submitted
- 21 Feb 2023
- Last updated
- 27 Jul 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- Yes: Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of Contrast Enhanced Digital Breast Tomosynthesis and Magnetic Resonance Imaging in Patients With Known Breast Lesions
- ClinicalTrials.gov ID
- NCT05754749
- Acronym / sponsor ID
- LCCC2139
- Conditions
- Breast Cancer
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Funding unavailable
- Enrolment
- 4 participants (actual)
- Lead sponsor
- UNC Lineberger Comprehensive Cancer CenterUniversity, hospital or other
- Study start
- 13 Mar 2023 (actual)
- Primary completion
- 20 May 2026 (actual)
- Study completion
- 20 May 2026 (actual)
- First posted
- 6 Mar 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
This is a pilot study of CE-DBT scans to evaluate its utility relative to breast CE-MRI. Twenty women who have planned or received conventional breast MRI imaging at UNC Hospitals will be recruited for the study. Participants will be scanned with the DBT system after the administration of iodinated contrast agent. Images will be acquired prior to the administration of contrast, followed by at approximately 2 minutes and 5 minutes. For the purposes of this study, imaging will focus on a single breast to simplify data acquisition.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Contrast-enhanced digital breast tomosynthesis (CE-DBT) | Experimental | Drug: Iohexol 350 Mg/mL Injectable SolutionParticipants with known breast lesions will be imaged using contrast-enhanced digital breast tomosynthesis (CE-DBT) with Iohexol 350 mg I/mL. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (5 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Iohexol 350 Mg/mL Injectable SolutionAlso: Contrast- enhanced digital breast tomosynthesis (CE-DBT)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. | Drug | Contrast-enhanced digital breast tomosynthesis (CE-DBT) |
Primary outcome
Reader confidence in identifying lesions on CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)
Time frame: Calculated once all imaging is complete [Anticipated 1.5 years]
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.
6 secondary outcomes
Contrast enhancement curves of CE-DBT compared to conventional MRI (arbitrary units)
Time frame: Calculated once all imaging is complete [Anticipated 1.5 years]
Diagnostic accuracy of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)
Time frame: Calculated once all imaging is complete [Anticipated 1.5 years]
Sensitivity of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)
Time frame: Calculated once all imaging is complete [Anticipated 1.5 years]
Specificity of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)
Time frame: 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)
Time frame: Calculated once all imaging is complete [Anticipated 1.5 years]
Receiver Operating Characteristic (ROC) curves of CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units)
Time frame: Calculated once all imaging is complete [Anticipated 1.5 years]
Results and safety
The study was stopped early (reason given: Funding unavailable). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2026.
- Individual participant dataSharing planned: Yes. Deidentified individual data that supports the results will be shared beginning 9 to 36 months following publication provided the investigator who proposes to use the data has approval from an Institutional Review Board (IRB), Independent Ethics Committee (IEC), or Research Ethics Board (REB), as applicable, and executes a data use/sharing agreement with UNC.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rachel Hitt, MD principal investigator
University of North Carolina, Chapel Hill
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Iohexol 350 Mg/mL Injectable Solution in people with Breast Cancer, run by UNC Lineberger Comprehensive Cancer Center at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 27 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Funding unavailable). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Reader confidence in identifying lesions on CE-DBT compared to contrast enhanced dynamic breast MRI (arbitrary units) (time frame: Calculated once all imaging is complete [Anticipated 1.5 years]). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2026.