N/A
N=72
The Prone to Supine Breast MRI Trial
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT03573804 ↗Enrolled (actual)
72
Serious AEs
0.0%
Results posted
Aug 2021
Primary outcome: Primary: Number of Successful Segmentation of Supine MRI Images — 54; 61 Participants
Study Design & Population
- Study type
- Interventional
- Phase
- N/A
- Interventions
- Prone to Supine MRI (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Dartmouth-Hitchcock Medical Center
- Primary completion
- Jul 2020
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Number of Successful Segmentation of Supine MRI Images |
54; 61 | — |
| SECONDARY Enhancement Quantification, as Measured by Signal Intensity - Segmented Tumor |
370.09; 594.77 | <0.001 sig |
| SECONDARY Enhancement Quantification, as Measured by Signal Intensity - Tumor Boundary |
217.96; 383.80 | <0.001 sig |
| SECONDARY Enhancement Quantification- Tumor-to-Background Ratio |
1.74; 1.62 | 0.0058 sig |
| SECONDARY Time to Position and Obtain Supine Images |
7.25 | — |
| SECONDARY Overall Comfort for Prone and Supine Positions |
1.82; 0.61 | 0.00049664 sig |
Summary
The purpose of this study is to determine whether a supine MRI obtained immediately after a standard diagnostic prone MRI exam, without a second injection of gadolinium (Gd) contrast material, would be of sufficient quality to allow the Radiologist to define the tumor edges ("segment" the tumor) so that a 3-D image of the tumor can be generated to form a BCL.
Eligibility Criteria
Inclusion Criteria
- Age > 18 years.
- Female gender.
- Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ
- Tumor size at least 1 cm in diameter as visualized on mammogram or US.
- A diagnostic breast MRI is considered to be clinically indicated.
- Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted.
Exclusion Criteria
- Absolute contraindication to MRI, including presence of implanted electrical device (pacemaker or neurostimulator), aneurysm clip, or metallic foreign body in or near eyes.
- Severe claustrophobia.
- Contraindication to use of gadolinium-based intravenous contrast, including life- threatening allergy or compromised renal function (eGFR < 30 ml/min/1.73m2).
- History of median sternotomy.
- Pregnancy. Patient attestation that they are not pregnant will be acceptable.
- Patients who have received neoadjuvant chemotherapy.
Data sourced from ClinicalTrials.gov (NCT03573804). 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.