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

Region Halland

Status

Active, not recruiting

Conditions

Breast Cancer

Treatments

Diagnostic Test: Contrast Enhanced Mammography (CEM)

Study type

Interventional

Funder types

Other

Identifiers

NCT04437602

2019-02661

Details and patient eligibility

About

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.

Enrollment

441 patients

Sex

Female

Ages

18+ years old

Volunteers

No Healthy Volunteers

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