Breast Cancer Clinical Trial
— PRIMAROfficial title:
Preoperative Magnetic Resonance Imaging to Obtain Adequate Resection Margins (PRIMAR) Trial
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?
Status | Recruiting |
Enrollment | 440 |
Est. completion date | August 31, 2026 |
Est. primary completion date | February 1, 2026 |
Accepts healthy volunteers | No |
Gender | Female |
Age group | 18 Years and older |
Eligibility | 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) |
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Plastic- and Breast Surgery, Aarhus University Hospital | Aarhus | |
Denmark | Department of Surgery, Viborg Regional Hospital | Viborg |
Lead Sponsor | Collaborator |
---|---|
Aarhus University Hospital |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Involved resection margins in the final histopathology | The number of involved (positive) resection margins in the final histopathology after breast conserving surgery that lead to repeat surgery. | 2 weeks (Time from the day of preoperative breast Magnetic Resonance Imaging (MRI) to the final histopathology postoperatively) | |
Primary | Number of re-excisions during breast conserving surgery | The number of patients where additional breast tissue is removed during initial breast conserving surgery. | 1 week | |
Secondary | Number of additional malignant tumors and Ductal Carcinoma in Situ (DCIS) in the breast detected | The number of additional malignant tumors and DCIS in the breast detected (MRI vs. standard methods) | 2 weeks | |
Secondary | Type of repeat surgery | Type of repeat surgery: Breast conserving surgery or mastectomy | 1 |
Status | Clinical Trial | Phase | |
---|---|---|---|
Recruiting |
NCT04681911 -
Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer
|
Phase 2 | |
Completed |
NCT04890327 -
Web-based Family History Tool
|
N/A | |
Terminated |
NCT04066790 -
Pyrotinib or Trastuzumab Plus Nab-paclitaxel as Neoadjuvant Therapy in HER2-positive Breast Cancer
|
Phase 2 | |
Completed |
NCT03591848 -
Pilot Study of a Web-based Decision Aid for Young Women With Breast Cancer, During the Proposal for Preservation of Fertility
|
N/A | |
Recruiting |
NCT03954197 -
Evaluation of Priming Before in Vitro Maturation for Fertility Preservation in Breast Cancer Patients
|
N/A | |
Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
Active, not recruiting |
NCT01472094 -
The Hurria Older PatiEnts (HOPE) With Breast Cancer Study
|
||
Completed |
NCT06049446 -
Combining CEM and Magnetic Seed Localization of Non-Palpable Breast Tumors
|
||
Withdrawn |
NCT06057636 -
Hypnosis for Pain in Black Women With Advanced Breast Cancer: A Feasibility Study
|
N/A | |
Recruiting |
NCT05560334 -
A Single-Arm, Open, Exploratory Clinical Study of Pemigatinib in the Treatment of HER2-negative Advanced Breast Cancer Patients With FGFR Alterations
|
Phase 2 | |
Active, not recruiting |
NCT05501769 -
ARV-471 in Combination With Everolimus for the Treatment of Advanced or Metastatic ER+, HER2- Breast Cancer
|
Phase 1 | |
Recruiting |
NCT04631835 -
Phase I Study of the HS-10352 in Patients With Advanced Breast Cancer
|
Phase 1 | |
Completed |
NCT04307407 -
Exercise in Breast Cancer Survivors
|
N/A | |
Recruiting |
NCT03544762 -
Correlation of 16α-[18F]Fluoro-17β-estradiol PET Imaging With ESR1 Mutation
|
Phase 3 | |
Terminated |
NCT02482389 -
Study of Preoperative Boost Radiotherapy
|
N/A | |
Enrolling by invitation |
NCT00068003 -
Harvesting Cells for Experimental Cancer Treatments
|
||
Completed |
NCT00226967 -
Stress, Diurnal Cortisol, and Breast Cancer Survival
|
||
Recruiting |
NCT06019325 -
Rhomboid Intercostal Plane Block on Chronic Pain Incidence and Acute Pain Scores After Mastectomy
|
N/A | |
Recruiting |
NCT06006390 -
CEA Targeting Chimeric Antigen Receptor T Lymphocytes (CAR-T) in the Treatment of CEA Positive Advanced Solid Tumors
|
Phase 1/Phase 2 | |
Recruiting |
NCT06037954 -
A Study of Mental Health Care in People With Cancer
|
N/A |