Breast Cancer Clinical Trial
Official title:
64Cu-DOTA-AE105. Evaluation of a New Radiotracer Targeting uPAR (Urokinase Plasminogen Activator Receptor) for Positron Emission Tomography Imaging of the Invasive Cancer Phenotype. First in Man.
Verified date | December 2014 |
Source | Rigshospitalet, Denmark |
Contact | n/a |
Is FDA regulated | No |
Health authority | Denmark: Danish Health and Medicines Authority |
Study type | Interventional |
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).
Status | Completed |
Enrollment | 10 |
Est. completion date | October 2014 |
Est. primary completion date | October 2014 |
Accepts healthy volunteers | No |
Gender | Both |
Age group | 18 Years to 80 Years |
Eligibility |
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 |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
Country | Name | City | State |
---|---|---|---|
Denmark | Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet | Copenhagen |
Lead Sponsor | Collaborator |
---|---|
Rigshospitalet, Denmark |
Denmark,
Persson M, Madsen J, Østergaard S, Jensen MM, Jørgensen 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. — View Citation
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Biodistribution | 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 | 24 hours | No |
Primary | Dosimetry | 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 | 24 hours | No |
Secondary | Expression of UPAR in tumor tissue | 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. | 24 hours | No |
Secondary | Quantitative uptake of UPAR in tumor tissue | 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 | 24 hours | No |
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