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| Name | Class |
|---|---|
| Link Campus University | OTHER |
| University of Campania Luigi Vanvitelli | OTHER |
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This study aims to evaluate the role of Contrast-Enhanced Mammography (CEM) in identifying the primary tumor site in patients presenting with Cancer of Unknown Primary (CUP) syndrome. By integrating functional and anatomical imaging, the study explores CEM's diagnostic value compared to standard imaging modalities in a single-center setting.
The study of CUP syndrome was conducted with MRI, but we propose the study with CEM
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Contrast-Enhanced Mammography (CEM) | Diagnostic Test | The intervention in this study involves Contrast-Enhanced Mammography (CEM), a specialized imaging technique that combines standard mammography with contrast-enhanced imaging to detect neo-angiogenesis, which is a characteristic of malignancy. Unlike traditional mammography, CEM utilizes both low-energy and high-energy images to provide enhanced visualization of tissue vascularity, aiding in the identification of occult primary tumors, particularly in patients with Cancer of Unknown Primary (CUP) syndrome. Patients who present with CUP syndrome, suspected of having a primary breast malignancy, will undergo CEM as part of their diagnostic workup. The CEM findings will be compared with other conventional imaging modalities, including ultrasound and MRI, to assess the diagnostic accuracy of CEM in detecting primary breast tumors. The intervention will also involve correlating the imaging results with histopathological findings from biopsy or surgical specimens. This study aims to demons |
| Measure | Description | Time Frame |
|---|---|---|
| Detection Rate of Primary Tumors using Contrast-Enhanced Mammography (CEM) in Patients with CUP Syndrome | The primary outcome of this study is the detection rate of primary tumors in patients presenting with Cancer of Unknown Primary (CUP) syndrome using Contrast-Enhanced Mammography (CEM). The detection rate will be determined by comparing the CEM findings with histopathological results from biopsies or surgical specimens. This will allow us to assess the diagnostic accuracy of CEM in identifying occult primary tumors, particularly in the context of breast cancer. | From enrollment to the end of treatment at 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity, Specificity, and Diagnostic Accuracy of CEM compared to Standard Imaging Modalities (Ultrasound, MRI, Mammography) | This secondary outcome aims to evaluate the sensitivity, specificity, and diagnostic accuracy of CEM in detecting primary tumors compared to other conventional imaging techniques, including ultrasound, MRI, and standard mammography. These metrics will be analyzed to determine the relative effectiveness of CEM as a diagnostic tool. |
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Inclusion Criteria:
Exclusion Criteria:
This study is open to cisgender women and transgender women who have breast tissue and are presenting with Cancer of Unknown Primary (CUP) syndrome and suspected primary breast malignancy. Individuals must have mammary tissue to be eligible for participation, as the study involves Contrast-Enhanced Mammography (CEM), which is specifically used to evaluate breast malignancies.
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The study population will consist of adult patients (aged 18 years and older) who are diagnosed with Cancer of Unknown Primary (CUP) syndrome and are suspected of having a primary breast malignancy based on clinical presentation or imaging findings. Eligible patients will have breast tissue suitable for Contrast-Enhanced Mammography (CEM) and will undergo CEM as part of their diagnostic workup to evaluate the potential primary tumor site.
The population will be diverse in terms of age, race, and ethnic backgrounds, provided they meet the inclusion criteria and do not fall under any of the exclusion criteria listed.
The study aims to include a cohort of patients with different stages of CUP syndrome to evaluate the effectiveness of CEM in identifying hidden primary tumors and its impact on clinical management and treatment decisions.
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| Name | Affiliation | Role |
|---|---|---|
| Graziella Di Grezia, medicine and surgery | Link Campus University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Link Campus University | Rome | 80138 | Italy |
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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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| From enrollment to the end of treatment at 12 months |
| Correlation of CEM Findings with Histopathological Results | This measure aims to correlate the CEM findings with the histopathological results from biopsy or surgical specimens. This will assess how well the CEM images match the final diagnosis of primary tumors based on tissue analysis. | From enrollment to the end of treatment at 12 months |
| D017437 |
| Skin and Connective Tissue Diseases |