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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| CEM | Experimental | Patients in experimental arm will go through additional preoperative staging with contrast enhanced mammography |
|
| No CEM | No Intervention | Patients in No intervention arm will go through no additional preoperative imaging |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast Enhanced Mammography (CEM) | Diagnostic Test | Additional CEM in preoperative staging |
|
| 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 |
| 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 |
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Inclusion Criteria:
Exclusion Criteria:
Breast cancer is very uncommon among men.
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| Name | Affiliation | Role |
|---|---|---|
| Kristina Ahsberg, PhD | Region Halland | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Halland Hospital Halmstad | Halmstad | 301 85 | Sweden | |||
| Helsingborg Hospital |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34663236 | Background | Ahsberg K, Gardfjell A, Nimeus E, Ryden L, Zackrisson S. The PROCEM study protocol: Added value of preoperative contrast-enhanced mammography in staging of malignant breast lesions - a prospective randomized multicenter study. BMC Cancer. 2021 Oct 18;21(1):1115. doi: 10.1186/s12885-021-08832-2. | |
| 32438917 | Result |
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No plan
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| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
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Prospective Randomized Trial
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| Within three months after diagnosis of breast cancer |
| Helsingborg |
| 252 23 |
| Sweden |
| Central Hospital Kristianstad | Kristianstad | 291 33 | Sweden |
| Ahsberg K, Gardfjell A, Nimeus E, Rasmussen R, Behmer C, Zackrisson S, Ryden L. Added value of contrast-enhanced mammography (CEM) in staging of malignant breast lesions-a feasibility study. World J Surg Oncol. 2020 May 21;18(1):100. doi: 10.1186/s12957-020-01865-0. |
| D017437 |
| Skin and Connective Tissue Diseases |