Comment Period Extended to 3/23/2015 for Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Evaluation of a New Radiotracer (64Cu-DOTA-AE105) for Diagnosing Aggressive Cancer With Positron Emission Tomography

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Dorthe Skovgaard, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT02139371
First received: May 12, 2014
Last updated: December 11, 2014
Last verified: December 2014

May 12, 2014
December 11, 2014
May 2014
October 2014   (final data collection date for primary outcome measure)
  • Biodistribution [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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
Same as current
Complete list of historical versions of study NCT02139371 on ClinicalTrials.gov Archive Site
  • Expression of UPAR in tumor tissue [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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 [ Time Frame: 24 hours ] [ Designated as safety issue: No ]
    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
Same as current
Not Provided
Not Provided
 
Evaluation of a New Radiotracer (64Cu-DOTA-AE105) for Diagnosing Aggressive Cancer With Positron Emission Tomography
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.

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 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

Interventional
Phase 0
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Diagnostic
  • Breast Cancer
  • Prostate Cancer
  • Urinary Bladder Cancer
Other: Injection 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
Experimental: 64Cu-DOTA-AE105 PET
One injection of 64-Cu-DOTA-AE105 (app. 200 Mbq IV) followed by 3 PET scans 1,3 and 24 hours post injection
Intervention: Other: Injection of 64Cu-DOTA-AE105
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
10
October 2014
October 2014   (final data collection date for primary outcome measure)

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
Both
18 Years to 80 Years
No
Contact information is only displayed when the study is recruiting subjects
Denmark
 
NCT02139371
2013-574
No
Dorthe Skovgaard, Rigshospitalet, Denmark
Rigshospitalet, Denmark
Not Provided
Principal Investigator: Dorthe Skovgaard, MD, Phd Rigshospitalet, Denmark
Rigshospitalet, Denmark
December 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP