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

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.

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02139371
• Other study ID #: 2013-574
• Status: Completed
• Phase: Phase 0
• First received: May 12, 2014
• Last updated: December 11, 2014
• Start date: May 2014
• Est. completion date: October 2014

Study information

• 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

Clinical Trial 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).

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

Recruitment information / eligibility

• 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

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic

Related Conditions & MeSH terms

• Breast Cancer
• Prostate Cancer
• Prostatic Neoplasms
• Urinary Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

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

Locations

Country	Name	City	State
Denmark	Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet	Copenhagen

Sponsors (1)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark

Country where clinical trial is conducted

Denmark, 

References & Publications (1)

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

Outcome

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