NCT02437539

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

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Rigshospitalet, Denmark · Academic / Other
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

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).

Detailed description

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 scans (10 minutes, 1 and 2 hours post injection). The primary end points are safety, biodistribution and dosimetry of 68Ga-NOTA-AE105. In addition, the quantitative uptake of 68Ga-NOTA-AE105 will be compared to the expression of uPAR measured directly in tumor tissue obtained by surgery or biopsies. The project will be monitored and evaluated in accordance with the principles of Good Clinical Practice (GCP).

Conditions

• Breast Cancer
• Prostate Cancer
• Urinary Bladder Cancer

Interventions

Type	Name	Description
DRUG	Injection of 68Ga-NOTA-AE105	One injection of 68Ga-NOTA-AE 105
DEVICE	Positron Emission Tomography scans	Following injection of 68Ga-NOTA-AE105 the patients will be PET scanned at 10 minutes, 1 hour and 2 hours post injection

Timeline

• Start date: 2015-05-01
• Primary completion: 2015-08-01
• Completion: 2015-08-01
• First posted: 2015-05-07
• Last updated: 2015-08-24

Locations

1 site across 1 country: Denmark