Breast MRI
Conditions
Brief 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 be clinically feasible.
Interventions
DIAGNOSTIC_TESTBreast MRI
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.
DRUGStandard of care contrast agent, provided in split dose
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.
Sponsors
Manojkumar Saranathan
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
30 Years to 89 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of Image Quality Comparisons for Viability of Low Dose Contrast | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Development of Deep-Learning Based Methods to Improve Image Quality | Through study completion, up to two years | 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. |
Countries
United States
Contacts
CONTACTSara Schiller Sr Research Program Manager, Radiology, MPH
Outcome results
None listed