uPAR PET/CT for Preoperative Staging of Breast Cancer Patients

Study Overview
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Brief Summary
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The sensitivity and specificity of uPAR PET/CT for preoperative detection of lymph node metastases in breast cancer.

Detailed Description
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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.

Official Title
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Phase II Trial: uPAR PET/CT for Preoperative Staging of Breast Cancer Patients

Conditions
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Breast Cancer

Intervention / Treatment
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* Other: 68Ga-NOTA-AE105
* Device: Positron Emission Tomography PET/CT


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Biopsy-verified breast cancer Primary tumor more than 2 cm (ultrasound or clinically) The participants must be capable of understanding and giving full informed written consent Exclusion Criteria: Pregnancy Lactation/breast feeding Weight above 140 kg Treatment with neoadjuvant chemotherapy Known allergy towards the IMP

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: uPAR PET<br>One injection of 68Ga-NOTA-AE105 followed by Positron Emission Tomography (PET/CT scan) to evaluate possible axillary lymph node metastatic lesions | Other: 68Ga-NOTA-AE105<br>* One injection of 68Ga-NOTA-AE105<br>Device: Positron Emission Tomography PET/CT<br>* Following injection of 68Ga-NOTA-AE105 the patients will be subjected to Positron Emission Tomography PET/CT<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | 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 | 

Secondary Outcome Measures

| Outcome Measure | 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 | 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 |