Trial | NCT02437539  Report issue

Title

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

  • Phase

    Phase 1

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Intervention/Treatment

    68ga-nota-ae105 ...

  • Study Participants

    10
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).
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).
Study Started
May 31
2015
Primary Completion
Aug 31
2015
Study Completion
Aug 31
2015
Last Update
Aug 24
2015
Estimate

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

68Ga-NOTA-AE105 PET Experimental

One injection of 68Ga-NOTA-AE105 (app. 200 MBq) followed by 3 PET/CT scans 10 minutes, 1 hour and 2 hours post injection

Criteria 

Inclusion Criteria:

diagnosed with 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
No Results Posted