Breast MRILITE bMRINCT07864519
Low-dose Imaging TechniquE in Breast MRI
A study testing Breast MRI in people with Breast MRI, run by Manojkumar Saranathan at 1 site in United States.
Trial summary
The purpose of the study is to compare a low-dose contrast enhanced breast MRI (bMRI) protocol with a standard dose protocol, using a dual-dose injection technique. By assessing the conspicuity and enhancement of lesions detected during bMRI, the investigators hope to demonstrate that lower doses of contrast agent may… Read more about this study
- Who is it for?
- Ages 30 to 89 years, women only
- Conditions the study is for
- Breast MRI
- What is being tested?
- Breast MRI
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteUnited States
- Study dates
- 1 Nov 2026to 1 Jan 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 30 to 89 years
- Women only
- No healthy volunteers
- Adult, Older adult
Inclusion Criteria: • Women for whom a clinically indicated breast MRI has been ordered for diagnostic or screening purposes
-
Exclusion Criteria: • Age less than 30 or greater than 89 years old
- Contraindication to MRI examination with contrast
- Metal, foreign materials, or MRI-incompatible implants in the body
- Impaired kidney function, as evidenced by impaired eGFR (eGFR <60 mL/min/1.73 m²) and/or clinical documentation. eGFR that is equal or greater than 60 mL/min/1.73 m² is considered clinically normal.
- Known allergy to MRI contrast
- Prisoners
- Pregnant women: MRI with contrast is contraindicated for pregnant women. Contrast crosses the maternal placental barrier and teratogenicity is unknown
- Adults unable to provide informed consent
- Adult male patients with breast cancer or other breast findings
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Sara Schiller Sr Research Program Manager, Radiology, MPH contact
United States1 site
UMass Chan Medical School
Worcester, Massachusetts, 01655
Sara Schiller Sr Research Program Manager, Radiology, MPH, 774-548-1090, sara.schiller1@umassmed.edu
About this study
Official title: Low-dose Imaging TechniquE in Breast MRI: LITE bMRI
The purpose of the study is to compare a low-dose contrast enhanced breast MRI (bMRI) protocol with a standard dose protocol, using a dual-dose injection technique. By assessing the conspicuity and enhancement of lesions detected during bMRI, the investigators hope to demonstrate that lower doses of contrast agent may be clinically feasible.
- Conditions
- Breast MRI
- Being tested
- Standard of care contrast agent, provided in split dose, Breast MRI
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Standard of care contrast agent, provided in split doseDrug
Total dosage of the contrast agent provided is the same as for a clinically indicated standard of care breast MRI. To evaluate the low-dose images and compare them to standard dose images, we will deliver the contrast agent in two sequential administrations. First, a small fraction of the standard dose of contrast agent will be administered. Approximately 10 minutes after the first injection, the remaining dose (i.e. full dose -the low dose amount) of the standard contrast will be administered.
Breast MRIDiagnostic test
A standard of care breast MRI will be performed. One additional set of sequences will be captured, after the first portion of the split dose is administered.
| Study group | Role | What they receive |
|---|---|---|
| Comparison of a low-dose MRI protocol with a standard-dose protocol | Experimental | To evaluate the low-dose images and compare them to standard dose images, we will deliver the contrast agent in two sequential administrations. First, a small fraction of the standard dose of contrast agent will be administered followed by the acquisition of standard multi-phasic 3D breast MRI images. Approximately 10 minutes after the first injection, the remaining dose (i.e. full dose -the low dose amount) of the standard contrast will be administered, followed by the same imaging sequence performed after the first injection for comparisons.
The total dose of the contrast agent given to the participant is weight-dependent and is the same as that given during a standard clinical breast MRI. The method of delivery of contrast agent is the same: an intravenous line is placed in the hand or forearm, through which the syringe of contrast agent is connected. Receives: Drug: Standard of care contrast agent, provided in split dose; Diagnostic Test: Breast MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assessment of Image Quality Comparisons for Viability of Low Dose Contrast
The primary study endpoint is the preliminary assessment of image quality comparisons for viability of low-dose contrast.
Measured: Through study completion, up to two years
Secondary outcomes (1)
Development of Deep-Learning Based Methods to Improve Image Quality
The secondary study endpoint is the development of deep-learning based methods to improve the image quality of low-dose bMRI, specifically processing the low-dose images in a manner to make them consistent in appearance with full dose images.
Measured: Through study completion, up to two years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Oct 2026
- Study start1 Nov 2026 (estimated)
- Primary completion1 Nov 2028 (estimated)
- Study completion1 Jan 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast MRIStudies of the same condition, open and under way.
- 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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Manojkumar Saranathan
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Manojkumar Saranathan, University of Massachusetts, Worcester
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07864519
- Sponsor's protocol ID
- STUDY00003201
- Acronym
- LITE bMRI
- Status last verified
- Oct 2026
- First submitted
- 29 Sep 2026
- Last updated
- 7 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: No specific individual participant datasets will be shared to protect patient privacy.
Study at a glance
From the registry record, last updated by the sponsor on 7 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low-dose Imaging TechniquE in Breast MRI: LITE bMRI
- ClinicalTrials.gov ID
- NCT07864519
- Acronym / sponsor ID
- LITE bMRI / STUDY00003201
- Conditions
- Breast MRI
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Manojkumar SaranathanUniversity, hospital or other
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 1 Nov 2028 (estimated)
- Study completion
- 1 Jan 2029 (estimated)
- First posted
- 7 Oct 2026 (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 the study is to compare a low-dose contrast enhanced breast MRI (bMRI) protocol with a standard dose protocol, using a dual-dose injection technique. By assessing the conspicuity and enhancement of lesions detected during bMRI, the investigators hope to demonstrate that lower doses of contrast agent may be clinically feasible.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Comparison of a low-dose MRI protocol with a standard-dose protocol | Experimental | Drug: Standard of care contrast agent, provided in split dose, Diagnostic Test: Breast MRITo evaluate the low-dose images and compare them to standard dose images, we will deliver the contrast agent in two sequential administrations. First, a small fraction of the standard dose of contrast agent will be administered followed by the acquisition of standard multi-phasic 3D breast MRI images. Approximately 10 minutes after the first injection, the remaining dose (i.e. full dose -the low dose amount) of the standard contrast will be administered, followed by the same imaging sequence performed after the first injection for comparisons. The total dose of the contrast agent given to the participant is weight-dependent and is the same as that given during a standard clinical breast MRI. The method of delivery of contrast agent is the same: an intravenous line is placed in the hand or forearm, through which the syringe of contrast agent is connected. |
Who may qualify
- Ages
- 30 to 89 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
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 contrast agent, provided in split doseTotal dosage of the contrast agent provided is the same as for a clinically indicated standard of care breast MRI. To evaluate the low-dose images and compare them to standard dose images, we will deliver the contrast agent in two sequential administrations. First, a small fraction of the standard dose of contrast agent will be administered. Approximately 10 minutes after the first injection, the remaining dose (i.e. full dose -the low dose amount) of the standard contrast will be administered. | Drug | Comparison of a low-dose MRI protocol with a standard-dose protocol |
| Breast MRIA standard of care breast MRI will be performed. One additional set of sequences will be captured, after the first portion of the split dose is administered. | Diagnostic test | Comparison of a low-dose MRI protocol with a standard-dose protocol |
Primary outcome
Assessment of Image Quality Comparisons for Viability of Low Dose Contrast
Time frame: Through study completion, up to two years
The primary study endpoint is the preliminary assessment of image quality comparisons for viability of low-dose contrast.
1 secondary outcome
Development of Deep-Learning Based Methods to Improve Image Quality
Time frame: Through study completion, up to two years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 Oct 2026.
- Individual participant dataSharing planned: No. No specific individual participant datasets will be shared to protect patient privacy.
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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.
Sara Schiller Sr Research Program Manager, Radiology, MPH contact
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Breast MRI in people with Breast MRI, run by Manojkumar Saranathan 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?
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: opening soon, as of the sponsor's last update on 7 Oct 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Sara Schiller Sr Research Program Manager, Radiology, MPH (774-548-1090, sara.schiller1@umassmed.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assessment of Image Quality Comparisons for Viability of Low Dose Contrast (time frame: Through study completion, up to two 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 7 Oct 2026; AzTrials last refreshed its copy on 30 Oct 2026.