Clinical trial · Interventional
Preoperative Magnetic Resonance Imaging to Obtain Adequate Resection Margins in Breast Conserving Surgery, (PRIMAR) Trial
Preoperative Magnetic Resonance Imaging to Obtain Adequate Resection Margins (PRIMAR) 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): Difficulties recruiting the patients at one of the sites.
Summary
Brief summary (as posted)
The goal of this randomised study is to investigate if a supplementary preoperative breast Magnetic Resonance Imaging (MRI) improves the assessment of breast cancer and can help surgical planning such that sufficient resection margins can be obtained during breast conserving surgery. The main questions are: 1. Is preoperative breast MRI in addition to the currently used standard imaging methods ultrasound and mammography more accurate to detect Ductal Carcinoma in Situ and the invasive breast tumor compared to standard methods only? 2. Does preoperative breast MRI reduce the number of involved histological margins after breast conserving surgery in the MRI-group versus the control group?
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 | Device | — | UNRESOLVED |
| standard breast imaging | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- MRI-group
- description
- This group of patients are allocated to a supplementary preoperative breast Magnetic Resonance Imaging (MRI) in addition to standard preoperative breast imaging (ultrasound and mammography).
- interventionNames
- Device: Breast MRI
- Diagnostic Test: standard breast imaging
- type
- OTHER
- label
- Control group
- description
- This groups of patients are allocated to receive standard preoperative breast imaging only (ultrasound and mammography).
- interventionNames
- Diagnostic Test: standard breast imaging
Primary outcomes (2)
- measure
- Involved resection margins in the final histopathology
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Newly diagnosed women with biopsy-verified invasive breast cancer * Age \> 18 year * Eligible for Breast Conserving Surgery (BCS) based on preoperative ultrasound and mammography * Cooperative to receive an Magnetic Resonance Imaging (MRI)-examination Exclusion Criteria: * Planned mastectomy * Included patients where the planned BCS changes to mastectomy based on preoperative MRI * Patients where a preoperative MRI is requiered (patients treated with neoadjuvant therapy and complex cases where a preoperative MRI is needed) * Previous surgery for pre-malignant or malignant lesions in the breast * Pregnancy and lactation * Male breast cancer * Contraindications for an MRI-examination (pacemaker, severe kidney insufficiency with glomerular filtration rate \< 30 mL/min, and MRI incompatible implants or devices, claustrophobia, disability that prevents an MRI-examination in a prone position, allergy towards Dotarem (intravenous contrast agent for MRI)
References
Publications (0)
Data not yet available