Clinical trial · Interventional
21DIF039: Prone to Supine Breast MRI II, P2S2 Breast MRI Trial
Prone to Supine Breast MRI Trial II, P2S2 MRI Trial
- 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 breast MRI obtained with a second intravenous injection of gadolinium contrast immediately after a standard clinical prone breast MRI will provide sufficient tumor visualization to allow a Radiologist to define and outline the tumor edges ("segment" the tumor). Accurate segmentation will allow a 3-D image of the tumor to be generated to create a breast cancer locator (BCL) surgical device to in aid removal of breast cancers.
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 Female | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Supine MRI | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Supine MRI
- interventionNames
- Procedure: Supine MRI
Primary outcomes (1)
- measure
- Difference in mean tumor-to-fibroglandular contrast ratio in prone compared to supine breast MRI
- timeFrame
- Day of standard clinical MRI, 1 day
- description
- Determine the mean tumor-to-fibroglandular contrast in a two bolus intravenous contrast injection prone to supine breast MRI study and compare this to the mean tumor-to-fibroglandular contrast of a single-contrast injection prone to supine breast MRI study.
Secondary outcomes (1)
- measure
- Evaluate tumor visualization and segmentability on supine breast MRI exam with additional contrast injection obtained immediately after prone contrast breast MRI, and compare to tumor visualization and segmentability on clinical prone breast MRI.
- timeFrame
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: 1. Age \> 18 years. 2. Female gender. 3. Histologic diagnosis of invasive breast cancer or ductal carcinoma in situ. 4. Tumor size at least 1 cm in diameter as visualized on mammogram or US. 5. A staging, pre-operative breast MRI is considered to be clinically indicated. 6. Ability to voluntarily provide informed consent to participate prior to any study-related assessments/procedures being conducted. Exclusion Criteria: 1. Absolute contraindication to MRI, including presence of implanted electrical device. (pacemaker or neurostimulator incompatible with MRI), aneurysm clip, or metallic foreign body in or near eyes. 2. Severe claustrophobia. 3. Contraindication to the use of gadolinium-based intravenous contrast, including anaphylaxis. Any known history of nephrogenic systemic fibrosis (NSF). 4. History of median sternotomy. 5. Pregnancy. All women of child-bearing age will be questioned about possible pregnancy status. In women who are unsure of pregnancy status, a urine pregnancy test will be performed. 6. Patients who have received neoadjuvant chemotherapy for their current diagnosis. 7. Known compromised renal function including chronic, severe kidney disease (GFR \< 30 ml/min/1.73m2), or acute kidney injury.
References
Publications (0)
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