Breast Cancer, Prostate Cancer, Urinary Bladder Cancer
Conditions
Keywords
Positron Emission Tomography, Uroplasminogen Plasminogen Activator Receptor, Breast cancer, Prostate cancer, Urinary bladder cancer, Biodistribution, Radiation exposure
Brief summary
The primary objective of the study is to test a new radiotracer called 64Cu-DOTA-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 (1,3 and 24 hours post injection).
Detailed description
The primary objective of the study is to test a new radiotracer called 64Cu-DOTA-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 (1,3 and 24 hours post injection). The primary end points are Biodistribution and dosimetry of 64Cu-DOTA-AE105. In addition, the quantitative uptake of 64Cu-DOTA-AE105 in tumors and expression of uPAR in tumor tissue obtained by surgery or biopsies (either 14 days before (only biopsies) or after the PET scans) will be compared to validate the image-derived data on UPAR expression
Interventions
OTHERInjection of 64Cu-DOTA-AE105
One injection of 64Cu-DOTA-AE105 (app. 200 Mbq) followed by Positron Emission Tomography Scan 1, 3 and 24 hours post injection
Sponsors
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
* clinical diagnosis of cancer of prostate, breast or urinary bladder * capable of understanding and giving full informed consent
Exclusion criteria
* pregnancy * lactation * contraindication for the use of intravenous CT contrast-agencies * claustrophobia * other current/or former diagnosed cancers, except non melanoma skin cancer or carcinoma in situ cervicis uteri
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Biodistribution | 24 hours | The patients will be PET scanned 1, 3 and 24 hours post injection of the radiotracer 64Cu-DOTA-AE105. These different timepoints will be used for assessment of biodistribution |
| Dosimetry | 24 hours | The patients will be PET scanned 1, 3 and 24 hours post injection of the radiotracer 64Cu-DOTA-AE105. These different timepoints will be used for calculation of dosimetry |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Expression of UPAR in tumor tissue | 24 hours | Tumor uptake of 64Cu-DOTA-AE105 will be compared with expression of uPAR (using immunohistochemistry and ELISA) in tumor tissue obtained from biopsies/or operative removal of the tumors. |
| Quantitative uptake of UPAR in tumor tissue | 24 hours | The patients will be PET scanned 1, 3 and 24 hours post injection of the radiotracer 64Cu-DOTA-AE105. These different timepoints will be used for assessment of tumor uptake of 64Cu-DOTA-AE105 will be assessed by PET scans 1, 3 and 24 hours post injection |
Countries
Denmark
Outcome results
None listed