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

Rigshospitalet

Status and phase: Completed; Early Phase 1

Conditions: Urinary Bladder Cancer; Breast Cancer; Prostate Cancer

Treatments: Other: Injection of 64Cu-DOTA-AE105

Study type: Interventional

Funder types: Other

Identifiers

NCT02139371

2013-574

Details and patient eligibility

About

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).

Full 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

Enrollment: 10 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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10 participants in 1 patient group

64Cu-DOTA-AE105 PET

Experimental group

Description:

One injection of 64-Cu-DOTA-AE105 (app. 200 Mbq IV) followed by 3 PET scans 1,3 and 24 hours post injection

Treatment:

Other: Injection of 64Cu-DOTA-AE105