Evaluation of a New Radiotracer (68Ga-NOTA-AE105) for Diagnosing Aggressive Cancer With Positron Emission Tomography (uPAR-PET)

Rigshospitalet

Status and phase: Completed; Phase 1

Conditions: Urinary Bladder Cancer; Breast Cancer; Prostate Cancer

Treatments: Drug: Injection of 68Ga-NOTA-AE105; Device: Positron Emission Tomography scans

Study type: Interventional

Funder types: Other

Identifiers

NCT02437539

2014-730

2014-005522-35 (EudraCT Number)

Details and patient eligibility

About

The primary objective of the study is to test a new radiotracer called 68Ga-NOTA-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 (10 minutes, 1 hour and 2 hours post injection).

Full description

The primary objective of the study is to test a new radiotracer called 68Ga-NOTA-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 scans (10 minutes, 1 and 2 hours post injection). The primary end points are safety, biodistribution and dosimetry of 68Ga-NOTA-AE105. In addition, the quantitative uptake of 68Ga-NOTA-AE105 will be compared to the expression of uPAR measured directly in tumor tissue obtained by surgery or biopsies. The project will be monitored and evaluated in accordance with the principles of Good Clinical Practice (GCP).

Enrollment: 10 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. diagnosed with cancer of prostate, breast or urinary bladder
2. capable of understanding and giving full informed consent

Exclusion criteria

1. pregnancy
2. lactation
3. contraindication for the use of intravenous CT contrast-agencies
4. claustrophobia

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

10 participants in 1 patient group

68Ga-NOTA-AE105 PET

Experimental group

Description:

One injection of 68Ga-NOTA-AE105 (app. 200 MBq) followed by 3 PET/CT scans 10 minutes, 1 hour and 2 hours post injection

Treatment:

Drug: Injection of 68Ga-NOTA-AE105

Device: Positron Emission Tomography scans