Clinical trial · Interventional
uPAR PET/CT for Preoperative Staging of Breast Cancer Patients
Phase II Trial: uPAR PET/CT for Preoperative Staging of Breast Cancer Patients
NCT02681640CI-TRIAL-00026834completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
The sensitivity and specificity of uPAR PET/CT for preoperative detection of lymph node metastases in breast cancer.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-NOTA-AE105 | Other | — | UNRESOLVED |
| Positron Emission Tomography PET/CT | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- uPAR PET
- description
- One injection of 68Ga-NOTA-AE105 followed by Positron Emission Tomography (PET/CT scan) to evaluate possible axillary lymph node metastatic lesions
- interventionNames
- Other: 68Ga-NOTA-AE105
- Device: Positron Emission Tomography PET/CT
Primary outcomes (1)
- measure
- Sensitivity and specificity of uPAR PET/CT in identifying axillary lymph node metastases from breast cancer
- timeFrame
- 1 hour
- description
- 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.
Secondary outcomes (2)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available
No reference posted for this study.