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

Not Applicable

Active, not recruiting

• Conditions: Breast Cancer
• Interventions: Diagnostic Test: Contrast Enhanced Mammography (CEM)

• Registration Number: NCT04437602
• Lead Sponsor: Region Halland

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-05-27
• Study First Submitted QC: 2020-06-17
• Study First Posted: 2020-06-18
• Study Start: 2020-11-02
• Primary Completion: 2024-04-30
• Status Verified: 2024-05
• Last Update Submitted: 2024-05-06
• Last Update Posted: 2024-05-07
• Study Completion: 2029-12-31

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: Female
• Target Recruitment: 441

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
CEM	Contrast Enhanced Mammography (CEM)	Patients in experimental arm will go through additional preoperative staging with contrast enhanced mammography

Primary Outcome Measures

Name	Time	Method
Rate of patients with change of primary treatment due to findings at additional CEM	Within two months after diagnosis of breast cancer	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

Secondary Outcome Measures

Name	Time	Method
Rate of reoperations	Within three months after diagnosis of breast cancer	Number of reoperations due to inadequate margins
Rate of avoidable mastectomies	Within three months after diagnosis of breast cancer	Patients operated with mastectomy where histopathology shows extent less than 3 cm

Trial Locations

Locations (3)

Halland Hospital Halmstad; 🇸🇪 Halmstad, Sweden

Helsingborg Hospital; 🇸🇪 Helsingborg, Sweden

Central Hospital Kristianstad; 🇸🇪 Kristianstad, Sweden