Preoperative Magnetic Resonance Imaging to Obtain Adequate Resection Margins in Breast Conserving Surgery, (PRIMAR) Trial

NCT05825768 | Terminated

• 1 other identifier: NNF19OC0057928
• Study Type: interventional
• Target: 227
• Locations: 1 country
• Sites: 2

Brief Summary

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. 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. 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

Breast Cancer

Keywords

Resection Margins; repeat surgery

Outcome Measures

Primary Outcomes (2)

• 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)

• 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 Outcomes (2)

• Number of additional malignant tumors and Ductal Carcinoma in Situ (DCIS) in the breast detected

  2 weeks

• Type of repeat surgery

  1

Study Arms (2)

MRI-group

ACTIVE COMPARATOR

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).

Device: Breast MRI; Diagnostic Test: standard breast imaging

Control group

OTHER

This groups of patients are allocated to receive standard preoperative breast imaging only (ultrasound and mammography).

Diagnostic Test: standard breast imaging

Interventions

Breast MRI DEVICE

Breast Magnetic Resonance Imaging prior to breast conserving surgery with and without intravenous contrast agent.

MRI-group

standard breast imaging DIAGNOSTIC_TEST

The control group that receives standard preoperative imaging only (breast ultrasound and mammography)

Control group; MRI-group

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Aarhus University Hospital: lead

Study Sites (2)

Department of Plastic- and Breast Surgery, Aarhus University Hospital

Aarhus, 8200, Denmark

Location

Department of Surgery, Viborg Regional Hospital

Viborg, 8800, Denmark

Location

MeSH Terms

Conditions

Breast Neoplasms; Margins of Excision

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Morphological and Microscopic Findings; Pathological Conditions, Signs and Symptoms

Study Officials

• Peer Christiansen, MD, DMSc

  Department of Plastic- and Breast Surgery, Aarhus University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, Medical Doctor

Model Details: Randomized, open-label, double-center trial including female participants with early breast cancer planned for breast conserving surgery randomised 1:1 in a Magnetic Resonance Imaging, MRI-group (preoperative MRI, ultrasound and mammography) and a control group (preoperative ultrasound and mammography).

Study Record Dates

• First Submitted: April 11, 2023
• First Posted: April 24, 2023
• Study Start: February 12, 2021
• Primary Completion: January 26, 2024
• Study Completion: February 15, 2024
• Last Updated: January 30, 2025

Record last verified: 2025-01

Data Sharing

• IPD Sharing: Will not share

Locations

DK (2)