Breast Cancer, Prostate Cancer, Urinary Bladder Cancer
Conditions
Brief 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).
Interventions
One injection of 68Ga-NOTA-AE 105
DEVICEPositron 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
Sponsors
Curasight
Rigshospitalet, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biodistribution | 2 hours | 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 |
| Dosimetry | 2 hours | 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 calculation of dosimetry with the use of OLINDA/EXM software (mSv) |
| Safety | 2 hours | the patients will be monitored for safety (occurence of adverse events, vital signs, blood test parameters) following injection of the radiotracer 68Ga-NOTA-AE105 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Quantitative uptake of the radiotracer in tumor tissue | 2 hours | 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 tumor uptake |
Countries
Denmark
Outcome results
None listed