N/A
Completed N=28
Novel MRI Sequence MR Fingerprinting in Breast MRI Feasibility Study
Breast Screening
Source: ClinicalTrials.gov NCT03846947 ↗
Enrolled (actual)
28
Serious AEs
0.0%
Results posted
May 2023
Primary outcomePrimary: Ratio of Intensity Score of Normal Breast Tissue for Left Breast Tissue Compared to Right for T1 Imaging Sequence — 1.07 ratio
Summary
The purpose of this study is to evaluate potential clinical efficacy of a novel magnetic resonance imaging (MRI) approach, MR fingerprinting, capable of providing quantitative measures of important tissue properties, which could provide important insights into normal breast tissue. This new MRI sequence will be added to the screening breast Dynamic Contrast Enhanced (DCE) MRI for high risk normal patients.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Ratio of Intensity Score of Normal Breast Tissue for Left Breast Tissue Compared to Right for T1 Imaging Sequence |
1.07 | — |
| PRIMARY Ratio of Intensity Score of Normal Breast Tissue for Left Breast Tissue Compared to Right for T2 Imaging Sequence |
1.03 | — |
| PRIMARY Ratio of Intensity Score of Normal Breast Tissue for Left Breast Tissue Compared to Right for the Investigational (MRF) Imaging Sequence |
1.08 | — |
Eligibility Criteria
Inclusion Criteria
- English-speaking patients
- Ages 18 to 99 years old
- Scheduled to undergo a screening breast MRI study
- Capable and willing to provide signed informed consent
Exclusion Criteria
- Claustrophobia
- Presence of pacemaker, intracranial aneurysm clip, bladder stimulator, cochlear implant or metal near eyes or near pelvis that would create excessive imaging artifact
- Known hypersensitivity to contrast agent or to any component of contrast agent refractory to standard medications (antihistamines, steroids)
- Impaired kidney function (serum creatinine level > 1.8 mg/dl or a glomerular filtration rate 1 hour)
- Pregnancy or lactating female
- Previous history of mastectomy or lumpectomy
- Breast enhancements (i.e. implants)
Data sourced from ClinicalTrials.gov (NCT03846947). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.