Breast Cancer
Conditions
Keywords
Contrast Enhanced Mammography, Preoperative staging
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.
Interventions
DIAGNOSTIC_TESTContrast Enhanced Mammography (CEM)
Additional CEM in preoperative staging
Sponsors
Region Halland
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
DIAGNOSTIC
Masking
NONE
Intervention model description
Prospective Randomized Trial
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
Countries
Sweden
Outcome results
None listed