Clinical trial · Interventional
The Prone to Supine Breast MRI Trial
NCT03573804CI-TRIAL-00053574completedN/AResults postedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Prone to Supine MRI | Other | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Prone to Supine MRI
- description
- The patient will be placed in the prone position and undergo a standard Gd contrast-enhanced bilateral breast MRI. Immediately after the prone MRI is completed, the patient will be repositioned for the supine MRI. Prior to starting the prone MRI, the study MRI technician/investigator will explain to the patient and practice with the patient the steps needed to transition from the prone to the supine MRI, so as to facilitate a timely transition. Additional MRI images will only take about 10-15 minutes to obtain and will not require a second injection of contrast material.
- interventionNames
- Other: Prone to Supine MRI
Primary outcomes (1)
- measure
- Number of Successful Segmentation of Supine MRI Images
- timeFrame
- 30 minutes
- description
- Determine what number of cases that can be successfully segmented both from using post-contrast prone MRI images and also from using post contrast supine MRI images.
Secondary outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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.
References
Publications (2)
- BACKGROUNDBarth RJ Jr, Krishnaswamy V, Paulsen KD, Rooney TB, Wells WA, Rizzo E, Angeles CV, Marotti JD, Zuurbier RA, Black CC. A Patient-Specific 3D-Printed Form Accurately Transfers Supine MRI-Derived Tumor Localization Information to Guide Breast-Conserving Surgery. Ann Surg Oncol. 2017 Oct;24(10):2950-2956. doi: 10.1245/s10434-017-5979-z. Epub 2017 Aug 1. PMID 28766199
- BACKGROUNDLeong CS, Daniel BL, Herfkens RJ, Birdwell RL, Jeffrey SS, Ikeda DM, Sawyer-Glover AM, Glover GH. Characterization of breast lesion morphology with delayed 3DSSMT: an adjunct to dynamic breast MRI. J Magn Reson Imaging. 2000 Feb;11(2):87-96. doi: 10.1002/(sici)1522-2586(200002)11:23.0.co;2-e. PMID 10713939