Breast Benign TumorPhase 1NCT04340180
Evaluating the Performance of AI in Evaluating Breast MRI Performed With Dose Reduction
A Phase 1 study testing reduced 1/4 dose gadolinium Breast MRI with Artificial Intelligence (AI) to aid in evaluation. in people with Breast Benign Tumor and Breast Malignant Tumor, run by University of Alabama at Birmingham at 1 site in United States.
Trial summary
The purpose of this study is to evaluate the ability of AI to correctly aid in characterization of benign and malignant lesions even when a low dose of gadolinium is administered. This study is relevant for several reasons, most notably being the reduction of MRI dose and decreased gadolinium deposition in the brain. Read more about this study
- Who is it for?
- Ages 18 to 99 years, women only
- Conditions the study is for
- Breast Benign Tumor, Breast Malignant Tumor
- What is being tested?
- reduced 1/4 dose gadolinium Breast MRI with Artificial Intelligence (AI) to aid in evaluation.
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteUnited States
- Study dates
- 14 Jul 2021to 20 Jan 2026
- Phase
- 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 to 99 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patient between ≥ 18 years old and ≤ 99 years old
- Patients with newly diagnosed primary breast cancer
- Patient able and willing to participate in the trial
- Female patients between ≥ 18 years old and ≤ 99 years old
- Be referred for MRI for non-malignant indications (screening or BIRADS 3)
- Patients have had prior exam with known enhancing mass, nonmass enhancement, or focus/foci.
Who cannot join
- Non-female patients
- Patients < 18 years old
- Women who are lactating or pregnant
- Patients with recurrent breast cancer
- Patients who have already received neoadjuvant chemotherapy
- Unable to lie still on the imaging table for one (1) hour
- Patients that are unable to undergo MRI evaluation for reasons specific to MRI
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to evaluate the ability of AI to correctly aid in characterization of benign and malignant lesions even when a low dose of gadolinium is administered. This study is relevant for several reasons, most notably being the reduction of MRI dose and decreased gadolinium deposition in the brain. In addition, use of AI may provide increased sensitivity and specificity for the radiologist evaluating a breast MRI exam. Half of the population will have benign pathologies and the other half will have malignant pathologies.
Read the detailed description
The study involves each patient presenting for an initial MRI with a regular dose of gadolinium and then presenting at least 48 hours after (no less than 14 days later) for a ¼ dose (see below regarding dosing) gadolinium MRI exam. Both exams will be performed on a 1.5 Tesla magnet. Both exams will include a full protocol. The full dose contrast exam will be read as standard protocol. All images will be anonymized. Images from the reduced dose study will be collected and an AI algorithm applied. All three anonymized data sets (regular dose, low dose, and AI algorithm applied to low dose) will be provided to the readers.
Readers will be three attending radiologists specializing in breast imaging. Exams will be scored on quality, background parenchymal enhancement (BPE), and lesion conspicuity. Enhancing lesions will be identified and characterized by the radiologists in a document provided.
- Conditions
- Breast Benign Tumor, Breast Malignant Tumor
- Being tested
- Standard of Care (SOC) gadolinium Breast MRI, reduced 1/4 dose gadolinium Breast MRI with Artificial Intelligence (AI) to aid in evaluation.
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of Care (SOC) gadolinium Breast MRIDrug
Standard of Care (SOC) gadolinium Breast MRI
reduced 1/4 dose gadolinium Breast MRI with Artificial Intelligence (AI) to aid in evaluation.Drug
reduced 1/4 dose gadolinium Breast MRI with Artificial Intelligence (AI) to aid in evaluation.
| Study group | Role | What they receive |
|---|---|---|
| Subjects with enhancing breast lesions | Experimental | Not described Receives: Drug: Standard of Care (SOC) gadolinium Breast MRI; Drug: reduced 1/4 dose gadolinium Breast MRI with Artificial Intelligence (AI) to aid in evaluation. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Compare lesion conspicuity on a scale of 1-4 from low-dose and SOC-dose imaging.
Measured: From 1st SOC breast MRI to 2nd low-dose Breast MRI (48 hours to 14 days later).
Compare lesion size in millimeters from low-dose to SOC-dose imaging.
Measured: From 1st SOC breast MRI to 2nd low-dose Breast MRI (48 hours to 14 days later).
Compare lesion margins on a scale from 1-4 from low-dose and SOC-dose imaging.
Measured: From 1st SOC breast MRI to 2nd low-dose Breast MRI (48 hours to 14 days later).
Compare lesion internal enhancement pattern on a scale from 1-4 from low-dose and SOC- dose imaging.
Measured: From 1st SOC breast MRI to 2nd low-dose Breast MRI (48 hours to 14 days later).
Secondary outcomes (1)
Compare the overall background enhancement (scale per standard imaging guidelines. Minimal, mild, moderate, marked).
Measured: From 1st SOC breast MRI to 2nd low-dose Breast MRI (48 hours to 14 days later).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Apr 2020
- Study start14 Jul 2021
- Primary completion29 Sep 2022
- Study completion20 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Benign TumorStudies of the same condition, open and under way.
- More trials run by University of Alabama at BirminghamThe 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
- Phase 1
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Alabama at Birmingham
- Sponsor type
- University, hospital or other
- Collaborators
- Bracco Corporate
- Responsible party
- Principal investigator, Stefanie A. Woodard, University of Alabama at Birmingham
- Investigators
- Stefanie Woodard, MD, Principal investigator, University of Alabama at Birmingham
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04340180
- Sponsor's protocol ID
- IRB-300004720 R19-159
- Other IDs
- Bracco
- Status last verified
- Jan 2026
- First submitted
- 31 Mar 2020
- Last updated
- 1 Jul 2026
- Results posted
- No
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No: To be determined.
Study at a glance
From the registry record, last updated by the sponsor on 1 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluating the Performance of AI in Evaluating Breast MRI Performed With Dose Reduction
- ClinicalTrials.gov ID
- NCT04340180
- Acronym / sponsor ID
- IRB-300004720 R19-159
- Conditions
- Breast Benign Tumor, Breast Malignant Tumor
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 20 participants (actual)
- Lead sponsor
- University of Alabama at BirminghamUniversity, hospital or other
- Collaborators
- Bracco Corporate
- Study start
- 14 Jul 2021 (actual)
- Primary completion
- 29 Sep 2022 (actual)
- Study completion
- 20 Jan 2026 (actual)
- First posted
- 9 Apr 2020 (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 study is to evaluate the ability of AI to correctly aid in characterization of benign and malignant lesions even when a low dose of gadolinium is administered. This study is relevant for several reasons, most notably being the reduction of MRI dose and decreased gadolinium deposition in the brain. In addition, use of AI may provide increased sensitivity and specificity for the radiologist evaluating a breast MRI exam. Half of the population will have benign pathologies and the other half will have malignant pathologies.
Detailed description
The study involves each patient presenting for an initial MRI with a regular dose of gadolinium and then presenting at least 48 hours after (no less than 14 days later) for a ¼ dose (see below regarding dosing) gadolinium MRI exam. Both exams will be performed on a 1.5 Tesla magnet. Both exams will include a full protocol. The full dose contrast exam will be read as standard protocol. All images will be anonymized. Images from the reduced dose study will be collected and an AI algorithm applied. All three anonymized data sets (regular dose, low dose, and AI algorithm applied to low dose) will be provided to the readers.
Readers will be three attending radiologists specializing in breast imaging. Exams will be scored on quality, background parenchymal enhancement (BPE), and lesion conspicuity. Enhancing lesions will be identified and characterized by the radiologists in a document provided.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Subjects with enhancing breast lesions | Experimental | Drug: Standard of Care (SOC) gadolinium Breast MRI, Drug: reduced 1/4 dose gadolinium Breast MRI with Artificial Intelligence (AI) to aid in evaluation. |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Female patient between ≥ 18 years old and ≤ 99 years old
- Patients with newly diagnosed primary breast cancer
- Patient able and willing to participate in the trial
- Female patients between ≥ 18 years old and ≤ 99 years old
- Be referred for MRI for non-malignant indications (screening or BIRADS 3)
Key exclusion criteria (7 listed)
- Non-female patients
- Patients < 18 years old
- Women who are lactating or pregnant
- Patients with recurrent breast cancer
- Patients who have already received neoadjuvant chemotherapy
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 |
|---|---|---|
| Standard of Care (SOC) gadolinium Breast MRIStandard of Care (SOC) gadolinium Breast MRI | Drug | Subjects with enhancing breast lesions |
| reduced 1/4 dose gadolinium Breast MRI with Artificial Intelligence (AI) to aid in evaluation.reduced 1/4 dose gadolinium Breast MRI with Artificial Intelligence (AI) to aid in evaluation. | Drug | Subjects with enhancing breast lesions |
Primary outcome
Compare lesion conspicuity on a scale of 1-4 from low-dose and SOC-dose imaging.
Time frame: From 1st SOC breast MRI to 2nd low-dose Breast MRI (48 hours to 14 days later).
Compare lesion size in millimeters from low-dose to SOC-dose imaging.
Time frame: From 1st SOC breast MRI to 2nd low-dose Breast MRI (48 hours to 14 days later).
Compare lesion margins on a scale from 1-4 from low-dose and SOC-dose imaging.
Time frame: From 1st SOC breast MRI to 2nd low-dose Breast MRI (48 hours to 14 days later).
Compare lesion internal enhancement pattern on a scale from 1-4 from low-dose and SOC- dose imaging.
Time frame: From 1st SOC breast MRI to 2nd low-dose Breast MRI (48 hours to 14 days later).
1 secondary outcome
Compare the overall background enhancement (scale per standard imaging guidelines. Minimal, mild, moderate, marked).
Time frame: From 1st SOC breast MRI to 2nd low-dose Breast MRI (48 hours to 14 days later).
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Jul 2026.
- Individual participant dataSharing planned: No. To be determined.
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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.
Stefanie Woodard, MD principal investigator
University of Alabama at Birmingham
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing reduced 1/4 dose gadolinium Breast MRI with Artificial Intelligence (AI) to aid in evaluation. in people with Breast Benign Tumor and Breast Malignant Tumor, run by University of Alabama at Birmingham 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 6 inclusion and 7 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: finished, as of the sponsor's last update on 1 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?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Compare lesion conspicuity on a scale of 1-4 from low-dose and SOC-dose imaging. (time frame: From 1st SOC breast MRI to 2nd low-dose Breast MRI (48 hours to 14 days later).). The study lists 4 primary outcomes in all. 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 1 Jul 2026.