Clinical trial · Interventional
Prospective Comparison of Breast MRI vs Contrast Mammography Prior to Surgery in Breast Cancer Patients
Comparison of Breast MRI Versus Contrast Enhanced Mammography Prior to Surgery in Breast Cancer Patients: a Randomized Controlled Trial
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): No Participants enrolled.
Summary
Brief summary (as posted)
In current clinical practice, women with biopsy proven breast cancer can be sent for breast magnetic resonance imaging (MRI) or contrast enhanced mammography (CEM) prior to surgery in order to delineate the extent of a known cancer and / or assess for the presence of occult secondary cancers. This study seeks to compare the global costs (based on actual reimbursement rates) of CEM/breast MRI, downstream imaging testing, and diagnostic procedures in women randomized to breast MRI versus CEM. Secondary goals are to compare patient preferences for CEM vs MRI and clinically relevant outcomes (e.g. conversion from lumpectormy to mastecomy).
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 MRI | Diagnostic Test | — | UNRESOLVED |
| Contrast Enhanced Mammography | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- OTHER
- label
- Breast MRI
- description
- Patients in this arm will be randomized to receive a Breast MRI in order to delineate the extent of a known cancer and / or assess for the presence of occult secondary cancers
- interventionNames
- Diagnostic Test: Breast MRI
- type
- OTHER
- label
- Contrast Enhanced Mammography
- description
- Patients in this arm will be randomized to receive a Contrast Enhanced Mammograph in order to delineate the extent of a known cancer and / or assess for the presence of occult secondary cancers
- interventionNames
- Diagnostic Test: Contrast Enhanced Mammography
Primary outcomes (1)
- measure
- Global Costs
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Women aged 18 years or older with newly diagnosed breast cancer and planned breast conservation surgery * Clinically indicated referral for breast MRI or contrast mammogram prior to surgery * Provision of informed consent Exclusion Criteria: * Planned neoadjuvant chemotherapy * Patients that are medically unstable * Pregnancy * Patients with known contraindication to contrast mammography, including: * Glomerular filtration rate \<30 * Known adverse reaction to iodinated contrast material * Patients with known contraindication to Breast MRI including: * Glomerular filtration rate \<30 * Known adverse reaction to gadolinium contrast material * Non-MRI conditional device or catheter * Brain aneurysm clip implanted before 1995 * Cochlear implant * Ocular foreign body (e.g. metal shavings) * Insulin pump * Patients unable to read and understand English or Spanish (i.e. an inability to complete study questionnaires)
References
Publications (0)
Data not yet available