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

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ClinicalTrials.gov Identifier: NCT02139371
Recruitment Status : Completed
First Posted : May 15, 2014
Last Update Posted : December 12, 2014
Sponsor:
Information provided by (Responsible Party):

Study Description
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).

Condition or disease Intervention/treatment Phase
Breast Cancer Prostate Cancer Urinary Bladder Cancer Other: Injection of 64Cu-DOTA-AE105 Early Phase 1

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

Study Design

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 10 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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.
Study Start Date : May 2014
Primary Completion Date : October 2014
Study Completion Date : October 2014

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
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
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


Outcome Measures

Primary Outcome Measures :
  1. Biodistribution [ Time Frame: 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

  2. Dosimetry [ Time Frame: 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 Outcome Measures :
  1. Expression of UPAR in tumor tissue [ Time Frame: 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.

  2. Quantitative uptake of UPAR in tumor tissue [ Time Frame: 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


Eligibility Criteria

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02139371


Locations
Denmark
Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Copenhagen, Denmark, 2100
Sponsors and Collaborators
Rigshospitalet, Denmark
Investigators
Principal Investigator: Dorthe Skovgaard, MD, Phd Rigshospitalet, Denmark
More Information

Publications:
Responsible Party: Dorthe Skovgaard, MD, Phd, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier: NCT02139371     History of Changes
Other Study ID Numbers: 2013-574
First Posted: May 15, 2014    Key Record Dates
Last Update Posted: December 12, 2014
Last Verified: December 2014

Keywords provided by Dorthe Skovgaard, Rigshospitalet, Denmark:
Positron Emission Tomography
Uroplasminogen Plasminogen Activator Receptor
Breast cancer
Prostate cancer
Urinary bladder cancer
Biodistribution
Radiation exposure

Additional relevant MeSH terms:
Prostatic Neoplasms
Urinary Bladder Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Urologic Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Plasminogen
Fibrinolytic Agents
Fibrin Modulating Agents
Molecular Mechanisms of Pharmacological Action