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

N/AActive Not RecruitingNCT04437602

Region Halland441 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

DIAGNOSTIC

Masking

NONE

Enrollment

441

Conditions

Breast Cancer

Interventions

Eligibility

Sex: FEMALEMin age: 18 Years

Medical Language ↔ Plain English

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

Locations (3)

Halland Hospital Halmstad

Halmstad, Sweden

Helsingborg Hospital

Helsingborg, Sweden

Central Hospital Kristianstad

Kristianstad, Sweden

Outcomes

Primary Outcomes

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

Time frame: Within two months after diagnosis of breast cancer

Secondary Outcomes

Rate of reoperations

Number of reoperations due to inadequate margins

Time frame: Within three months after diagnosis of breast cancer

Rate of avoidable mastectomies

Patients operated with mastectomy where histopathology shows extent less than 3 cm

Time frame: Within three months after diagnosis of breast cancer