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| Name | Class |
|---|---|
| Karolinska Institutet | OTHER |
| Uppsala University Hospital | OTHER |
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The study is a prospective randomised multicenter trial assessing the additional value of breast MRI in women under 56 years of age with newly diagnosed breast cancer. Will preoperative breast MRI change treatment regimen? Will preoperative breast MRI reduce the number of primary surgeries? Will preoperative breast MRI increase the rate of mastectomies? Will preoperative breast MRI be cost effective?
Completed: the study has concluded normally; participants are no longer being examined or treated (i.e., last patient's last visit has occurred)
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| preoperative breast MRI | Experimental | The intervention is that preoperative MRI breast will be performed in women under 56 years with newly diagnosed breast cancer |
|
| no MRI breast | No Intervention | The arm type description implies that no MRI breast will be performed to women under 56 years with newly diagnosed breast cancer |
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MRI | Device | The intervention is that preoperative MRI breast will be performed in 220 women under 56 years with newly diagnosed breast cancer. Aims are to analyze if the intervention will affect primary management, decrease the number of reoperations and to analyze if the intervention leads to an increasing number of unnecessary mastectomies compared to the non intervention arm. |
| Measure | Description | Time Frame |
|---|---|---|
| Change of treatment plan | Did breast magnetic resonance imaging add information about the tumour that changed primary treatment plan | 14 days |
| Measure | Description | Time Frame |
|---|---|---|
| Did breast magnetic resonance imaging reduce the number of reoperation during primary management | 6 months | |
| Did breast magnetic resonance imaging increase the number of mastectomies | 6 months | |
| Measure | Description | Time Frame |
|---|---|---|
| Is the sensitivity of breast MRI dependant on density and/or on age | 14 days |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Brita Arver, MD PhD | Karolinska University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Karolinska Univeristy Hospital | Stockholm | Stockholm County | 17176 | Sweden |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 34611701 | Derived | Gonzalez V, Arver B, Lofgren L, Bergkvist L, Sandelin K, Eriksson S. Impact of preoperative breast MRI on 10-year survival of patients included in the Swedish randomized multicentre POMB trial. BJS Open. 2021 Sep 6;5(5):zrab088. doi: 10.1093/bjsopen/zrab088. |
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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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|
| Did breast magnetic resonance imaging affect cost |
| 6 months |
| D017437 |
| Skin and Connective Tissue Diseases |