Clinical trial · Interventional
Comparison of MRI and CEDM to Evaluate Treatment Response Before Surgery
Comparison of Breast Magnetic Resonance Imaging (MRI) and Contrast Enhanced Mammography (CEDM) to Evaluate Residual Disease Extent After Neoadjuvant Therapy (NAT)
NCT03070340CI-TRIAL-00071563completedN/AClinicalTrials.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 compare the diagnostic accuracy of breast magnetic resonance imaging (MRI) and contrast enhanced digital mammography (CEDM) in assessing the residual disease extent in patients who have completed neoadjuvant therapy (NAT).
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 (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Breast Magnetic Resonance Imaging (MRI) | Diagnostic Test | — | UNRESOLVED |
| Contrast Enhanced Mammography (CEDM) | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Breast MRI and Contrast Enhanced Mammography (CEDM)
- description
- Breast MRI and CEDM will be performed within 30 days of one another after neoadjuvant therapy
- interventionNames
- Diagnostic Test: Breast Magnetic Resonance Imaging (MRI)
- Diagnostic Test: Contrast Enhanced Mammography (CEDM)
Primary outcomes (1)
- measure
- Compare diagnostic accuracy of breast MRI and CEDM
- timeFrame
- 1 year
- description
- To compare the diagnostic accuracy of enhancement on MRI and CEDM in evaluating residual disease extent in women who have completed NAT prior to surgical excision
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Any woman who has completed or is nearing completion of neoadjuvant therapy for breast cancer and is scheduled for a post-NAT breast MRI and mammogram * Surgery (mastectomy or BCT) planned within 60 days of the MRI Exclusion Criteria: * Women who have a contraindication to the intravenous use of iodinated contrast agent (i.e., allergy to iodinated contrast or severely impaired renal function with a creatinine level \> 1.3 or eGFR ≥45) * Known allergic reaction to gadolinium; patient may be eligible if the referring physician determines that the MRI is medically necessary and if the patient is willing to undergo pre-medication for contrast allergy * Pregnant women * Male patients * Presence of non MR compatible metallic objects or metallic objects that, in the opinion of the radiologist, would make MRI a contraindication * Known or suspected renal impairment. Requirements for GFR prior to MRI as determined by local site standard practice * Women who have already had their standard of care post-NAT mammogram and/or breast MRI
References
Publications (0)
Data not yet available
No reference posted for this study.