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| Name | Class |
|---|---|
| Stockholm South General Hospital | OTHER |
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Women taking part in the National Mammography Screening Program, examined at Södersjukhuset Breast Centre at Södra station in Stockholm and recalled because of suspicion of breast cancer will be invited to participate. A Contrast Enhanced Mammography will be added to the standard of care procedures for investigating a suspicion of breast cancer and blinded from each other 2 radiologists will evaluate either the Contrast Enhanced Mammography or the standard of care examinations. When comparing the potentially extra findings with Contrast Enhanced Mammography will be calculated. Potential side effects together with the patient experience will also be evaluated.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Contrast Enhanced Mammography | Other | All included women go through a Contrast Enhanced Mammography added to the standard of care examinations. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast Enhanced Mammography | Combination Product | A modality for examining breast conditions which is already approved and used but the evaluation of its role in a recalled screening population is limited. Intravenous iodine contrast is given prior to the mammogram. |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity of Contrast Enhanced Mammography | Evaluating sensitivity of Contrast Enhanced Mammography in detecting multifocality and/or contralateral breast cancer, compared to standard breast radiology work-up methods. | 1 day |
| Measure | Description | Time Frame |
|---|---|---|
| Specificity of Contrast Enhanced Mammography | Estimate the specificity of Contrast Enhanced Mammography in detecting absence of breast cancer, compared to standard breast radiology work-up methods. | 1 day |
| Safety of Contrast Enhanced Mammography |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Magnus Bäcklund, MD PhD | Contact | +46704663164 | magnus.backlund@ki.se | |
| Per Hall, MD PhD | Contact | +46852480000 | +46852486152 | per.hall@ki.se |
| Name | Affiliation | Role |
|---|---|---|
| Per Hall, MD PhD | Karolinska Institutet | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bröstcentrum, Södersjukhuset | Recruiting | Stockholm | Sweden |
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| Label | URL |
|---|---|
| Research group web page | View source |
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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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The added Contrast Enhanced Mammography will be evaluated by a radiologist blinded from the radiologists evaluating the standard of care examinations.
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Evaluate the safety of using Contrast Enhanced Mammography, based on adverse event reporting. Potential adverse event will be collected, reported and, if necessary, intervened, on the day for the Contrast Enhanced Mammography and up to 30 days after. All adverse events will be put in to the eCRF.
| 30 days |
| Patient acceptance of Contrast Enhanced Mammography | Evaluate the acceptance in patients, based on a questionnaire at the end of the study visit and structured telephone interviews 1-2 weeks after. The answers to the questionnaire is on a 5-grade scale. The interviews will go deeper and summaries of the answers will be put in to the eCRF. | 30 days |
| Tumor size assessment | Comparing Contrast Enhanced Mammography with each standard breast radiology work-up method for tumor size assessment. | 1 day |
| Mammographic density influence on the performance of Contrast Enhanced Mammography | Evaluate if mammographic density influences the performance of Contrast Enhanced Mammography compared to standard breast radiology work-up methods. | 1 day |
| Contrast Enhanced Mammography costs | Calculate the costs for using Contrast Enhanced Mammography | 1 day |
| D017437 |
| Skin and Connective Tissue Diseases |