Added Value of Preoperative Contrast Enhanced Mammography in Staging of Malignant Breast Lesions

Study Overview
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Brief Summary
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Patients diagnosed with breast cancer after routine assessment with digital mammography and ultrasound and scheduled for primary surgery are included in the trial. The patients are randomized 1:1 to go through additional contrast enhanced mammography (CEM) or no further imaging preoperatively. Primary endpoint is rate of patients with change of treatment: a) mastectomy instead of partial mastectomy due larger unifocal or multifocal extent, b) partial mastectomy instead of mastectomy due to improved demarcation of the tumour area, c) bilateral surgery instead of unilateral due to findings of contralateral cancer, d) neoadjuvant therapy instead of primary surgery due to more advanced disease. Rate of reoperation and rate of avoidable mastectomies are secondary endpoints.

Official Title
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Added Value of Preoperative Contrast Enhanced Mammography (PROCEM) in Staging of Malignant Breast Lesions - a Prospective Randomized Multicenter Trial

Conditions
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Breast Cancer

Intervention / Treatment
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* Diagnostic Test: Contrast Enhanced Mammography (CEM)


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Planned primary surgery for suspicious or verified breast malignancy Age of 18 years and above Signed informed consent Exclusion Criteria: Planned neoadjuvant therapy On-going pregnancy Iodinated contrast agent allergy Renal failure (abnormal S-creatinine) Untreated thyreotoxicosis Severe heart failure Myastenia gravis Breast implant Local recurrence as index lesion Inability to understand and comprehend oral and written information of the study

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Prospective Randomized Trial
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: CEM<br>Patients in experimental arm will go through additional preoperative staging with contrast enhanced mammography | Diagnostic Test: Contrast Enhanced Mammography (CEM)<br>* Additional CEM in preoperative staging<br>|
| No Intervention: No CEM<br>Patients in No intervention arm will go through no additional preoperative imaging | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of patients with change of primary treatment due to findings at additional CEM | Mastectomy instead of partial mastectomy due to findings of multifocal disease, mastectomy instead of partial mastectomy due to larger unifocal extent, partial mastectomy instead of mastectomy due to improved demarcation of tumour area, bilateral surgery due to findings of contralateral cancer, primary neoadjuvant treatment instead of primary surgery due to more advanced disease | Within two months after diagnosis of breast cancer | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Rate of reoperations | Number of reoperations due to inadequate margins | Within three months after diagnosis of breast cancer | 
| Rate of avoidable mastectomies | Patients operated with mastectomy where histopathology shows extent less than 3 cm | Within three months after diagnosis of breast cancer | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Contrast Enhanced Mammography, Preoperative staging