Clinical trial · Interventional
Evaluation of a New Radiotracer (68Ga-NOTA-AE105) for Diagnosing Aggressive Cancer With Positron Emission Tomography
68Ga-NOTA-AE105. Evaluation of a New Radiotracer Targeting uPAR (Urokinase Plasminogen Activator Receptor), for Positron Emission Tomography Imaging of the Invasive Cancer Phenotype. First in Human
- 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 primary objective of the study is to test a new radiotracer called 68Ga-NOTA-AE105 for PET imaging of uPAR (urokinase plasminogen activator receptor). The tracer has the potential of identifying the invasive cancer phenotype, thereby distinguishing between aggressive and less aggressive tumors. This is a first in human study to test the radiotracer in cancer patients. The biodistribution and tumor uptake will be evaluated by repeated PET imaging (10 minutes, 1 hour and 2 hours post injection).
Conditions
Conditions (3)
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 |
| Prostate Cancer | Malignant Prostate Neoplasm | CURATED_EXACT | 0.92 |
| Urinary Bladder Cancer | Malignant Bladder Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Injection of 68Ga-NOTA-AE105 | Drug | — | UNRESOLVED |
| Positron Emission Tomography scans | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-NOTA-AE105 PET
- description
- One injection of 68Ga-NOTA-AE105 (app. 200 MBq) followed by 3 PET/CT scans 10 minutes, 1 hour and 2 hours post injection
- interventionNames
- Drug: Injection of 68Ga-NOTA-AE105
- Device: Positron Emission Tomography scans
Primary outcomes (3)
- measure
- Biodistribution
- timeFrame
- 2 hours
- description
- The patients will be PET scanned 10 minutes, 1 hour and 2 hours post injection of the radiotracer 68Ga-NOTA-AE105. These timepoints will be used for assessment of biodistribution
- measure
- Dosimetry
- timeFrame
- 2 hours
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 80 Years
Show eligibility criteria text
Inclusion Criteria: 1. diagnosed with cancer of prostate, breast or urinary bladder 2. capable of understanding and giving full informed consent Exclusion Criteria: 1. pregnancy 2. lactation 3. contraindication for the use of intravenous CT contrast-agencies 4. claustrophobia
References
Publications (1)
- RESULTPersson M, Madsen J, Ostergaard S, Jensen MM, Jorgensen JT, Juhl K, Lehmann C, Ploug M, Kjaer A. Quantitative PET of human urokinase-type plasminogen activator receptor with 64Cu-DOTA-AE105: implications for visualizing cancer invasion. J Nucl Med. 2012 Jan;53(1):138-45. doi: 10.2967/jnumed.110.083386. PMID 22213823