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The optimal dose of iodine based contrast agents used in contrast-enhanced spectral mammography (CESM) is unknown. If CESM, performed with lower dose of iodine based contrast agent, visualizes a tumor comparable to CESM with regular dose of contrast agent, patients can receive less contrast agent for CESM in future and thereby risking less side effects of the contrast agent.
In order to study whether CESM remains unchanged at smaller amounts of contrast administration, a second CESM exam will be performed within one week of the first with a an alternative amount of contrast, it being either 80%, 60% or 40% of the original contrast dose. The settings of the CESM unit will remain unchanged.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| arm A (40%) | Experimental | Patients randomized in arm A will receive a second CESM exam with 40% of the initial dose of the contrast agent. |
|
| arm B (60%) | Experimental | Patients randomized in arm A will receive a second CESM exam with 60% of the initial dose of the contrast agent. |
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| arm C (80%) | Experimental | Patients randomized in arm A will receive a second CESM exam with 80% of the initial dose of the contrast agent. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| CESM with a reduced dose of contrast agent | Procedure |
|
| Measure | Description | Time Frame |
|---|---|---|
| Accuracy of maximum tumor size measurements for breast cancer detected with the clinical CESM exam (reference) compared to the (experimental) CESM exams with varying (lower) dose concentrations. | After completion of final patient inclusion (e.g. 1 year) |
| Measure | Description | Time Frame |
|---|---|---|
| Enhancement measurements for breast cancer detected with the clinical CESM exam (reference) compared to the (experimental) CESM exams with varying (lower) dose concentrations. | After completion of final patient inclusion (e.g. 1 year) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc BI Lobbes, MD, PhD | Maastricht University Medical Center | Principal Investigator |
| Thiemo JA van Nijnatten, MD, PhD | Maastricht University Medical Center |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Maastricht University Medical Center | Maastricht | Netherlands |
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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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| D017437 |
| Skin and Connective Tissue Diseases |