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

This study is currently recruiting participants. (see Contacts and Locations)
Verified May 2014 by Rigshospitalet, Denmark
Sponsor:
Information provided by (Responsible Party):
Dorthe Skovgaard, Rigshospitalet, Denmark
ClinicalTrials.gov Identifier:
NCT02139371
First received: May 12, 2014
Last updated: May 14, 2014
Last verified: May 2014
  Purpose

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 Intervention Phase
Breast Cancer
Prostate Cancer
Urinary Bladder Cancer
Other: Injection of 64Cu-DOTA-AE105
Phase 0

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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.

Resource links provided by NLM:


Further study details as provided by Rigshospitalet, Denmark:

Primary Outcome Measures:
  • 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


Secondary Outcome Measures:
  • 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


Estimated Enrollment: 10
Study Start Date: May 2014
Estimated Study Completion Date: October 2014
Estimated Primary Completion Date: October 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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

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

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT02139371

Contacts
Contact: Dorthe Skovgaard, MD, Phd +4561274706 dskovgaard@dadlnet.dk

Locations
Denmark
Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet Recruiting
Copenhagen, Denmark, 2100
Contact: Dorthe Skovgaard, MD, PhD    +4561274706    dskovgaard@dadlnet.dk   
Principal Investigator: Dorthe Skovgaard, MD, Phd         
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
Study First Received: May 12, 2014
Last Updated: May 14, 2014
Health Authority: Denmark: Danish Health and Medicines Authority

Keywords provided by 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
Breast Neoplasms
Genital Neoplasms, Male
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Genital Diseases, Male
Prostatic Diseases
Urologic Neoplasms
Urinary Bladder Diseases
Urologic Diseases
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on September 22, 2014