Clinical trial NCT02139371: Evaluation of a New Radiotracer (64Cu-DOTA-AE105) for Diagnosing Aggressive Cancer With Positron Emission Tomography
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 type: INTERVENTIONAL
Overall status: COMPLETED
Phase: EARLY_PHASE1
Conditions: Breast Cancer
Prostate Cancer
Urinary Bladder Cancer
Keywords: Positron Emission Tomography
Uroplasminogen Plasminogen Activator Receptor
Breast cancer
Prostate cancer
Urinary bladder cancer
Biodistribution
Radiation exposure
Lead sponsor: Rigshospitalet, Denmark
Sponsor class: OTHER
First posted: 2014-05-15
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

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).

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 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

Primary outcomes:
measure: Biodistribution
timeFrame: 24 hours
measure: Dosimetry
timeFrame: 24 hours
Secondary outcomes:
measure: Expression of UPAR in tumor tissue
timeFrame: 24 hours
measure: Quantitative uptake of UPAR in tumor tissue
timeFrame: 24 hours
Other outcomes:
Locations:
city: Copenhagen
country: Denmark
facility: Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet
Study officials:
affiliation: Rigshospitalet, Denmark
name: Dorthe Skovgaard, MD, Phd
role: PRINCIPAL_INVESTIGATOR
References:
citation: Persson M, Madsen J, Ostergaard S, Jensen MM, Jorgensen 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.