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| Name | Class |
|---|---|
| Curasight ApS | UNKNOWN |
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The sensitivity and specificity of uPAR PET/CT for preoperative detection of lymph node metastases in breast cancer.
The sensitivity and specificity of uPAR PET/CT for detection of lymph node metastases will be tested by observer-blinded readings (two separate teams) and compared to diagnostic performance of conventional preoperative diagnostic workup procedures. The reference test will be histopathology of lymph nodes obtained by operative lymph node dissection (SN/ALND). Primary end point dichotomized: +/- lymph node metastases in ipsilateral axilla.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| uPAR PET | Experimental | One injection of 68Ga-NOTA-AE105 followed by Positron Emission Tomography (PET/CT scan) to evaluate possible axillary lymph node metastatic lesions |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-NOTA-AE105 | Other | One injection of 68Ga-NOTA-AE105 |
| |
| Positron Emission Tomography PET/CT |
| Measure | Description | Time Frame |
|---|---|---|
| Sensitivity and specificity of uPAR PET/CT in identifying axillary lymph node metastases from breast cancer | Two separate teams of certified specialists (1 radiology and 1 nuclear medicine) will based on uPAR-PET/CT assess the presence of metastases in axillary lymph nodes ("spread"/"no spread"). Lymph Node sampling and histopathology determine true positives and true negatives. | 1 hour |
| Measure | Description | Time Frame |
|---|---|---|
| Number of axillary lymph node metastasis | Two separate teams of certified specialists (1 radiology and 1 nuclear medicine) will based on uPAR-PET/CT assess the number of metastases in axillary lymph nodes. Lymph node sampling and histopathology determine true positives and true negatives. | 1 hour |
| Number of distant metastases |
| Measure | Description | Time Frame |
|---|---|---|
| Optimal time point for performing PET/CT following injection of 68Ga-NOTA-AE105 | The first 5 patients will be subjected to 60 minutes of dynamic PET imaging covering the breast tumor area, starting at the time of injection. The PET scan will be divided into 12 time frames of each 5 minutes. The time frame with the best visual tumor to background contrast, will be designated as the optimal time point p.i. for uPAR-PET/CT |
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Dorthe Skovgaard, MD PhD | Rigshospitalet, Denmark | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet | Copenhagen | Copenhagen | 2100 | Denmark |
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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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| ID | Term |
|---|---|
| D000072078 | Positron Emission Tomography Computed Tomography |
| ID | Term |
|---|---|
| D049268 | Positron-Emission Tomography |
| D014055 | Tomography, Emission-Computed |
| D007090 | Image Interpretation, Computer-Assisted |
| D003952 | Diagnostic Imaging |
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| Device |
Following injection of 68Ga-NOTA-AE105 the patients will be subjected to Positron Emission Tomography PET/CT |
|
Two separate teams of certified specialists (1 radiology and 1 nuclear medicine) will based on uPAR-PET/CT assess the number of distant metastases. Biopsy/follow up imaging will be used as reference. |
| 1 hour |
| 0-60 minutes |
| D017437 |
| Skin and Connective Tissue Diseases |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
| D014057 | Tomography, X-Ray Computed |
| D064847 | Multimodal Imaging |
| D011856 | Radiographic Image Enhancement |
| D007089 | Image Enhancement |
| D010781 | Photography |
| D011859 | Radiography |
| D014056 | Tomography, X-Ray |
| D011877 | Radionuclide Imaging |
| D014054 | Tomography |
| D003947 | Diagnostic Techniques, Radioisotope |