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

NCT05825768 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 227

Last updated 2025-01-30

No results posted yet for this study

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. 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

Interventions

DEVICE

Breast MRI

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

DIAGNOSTIC_TEST

standard breast imaging

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

Sponsors & Collaborators

  • Aarhus University Hospital

    lead OTHER

Principal Investigators

  • Peer Christiansen, MD, DMSc · Department of Plastic- and Breast Surgery, Aarhus University Hospital

Study Design

Allocation
RANDOMIZED
Purpose
DIAGNOSTIC
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-02-12
Primary Completion
2024-01-26
Completion
2024-02-15

Countries

  • Denmark

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05825768 on ClinicalTrials.gov