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

Breast Cancer Clinical Trial

— uPAR-PET  

Official title:

68Ga-NOTA-AE105. Evaluation of a New Radiotracer Targeting uPAR (Urokinase Plasminogen Activator Receptor), for Positron Emission Tomography Imaging of the Invasive Cancer Phenotype. First in Human

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02437539
• Other study ID #: 2014-730
• Secondary ID: 2014-005522-35
• Status: Completed
• Phase: Phase 1
• First received: April 28, 2015
• Last updated: August 21, 2015
• Start date: May 2015
• Est. completion date: August 2015

Study information

• Verified date: August 2015
• Source: Rigshospitalet, Denmark
• Contact: n/a
• Is FDA regulated: No
• Health authority: Denmark: Danish Health and Medicines AuthorityDenmark: The National Committee on Health Research Ethics
• Study type: Interventional

Clinical Trial Summary

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).

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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: August 2015
• Est. primary completion date: August 2015
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

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
• Urinary Bladder Cancer
• Urinary Bladder Neoplasms

Intervention

Drug:
• Injection of 68Ga-NOTA-AE105
One injection of 68Ga-NOTA-AE 105

Device:
• Positron Emission Tomography scans
Following injection of 68Ga-NOTA-AE105 the patients will be PET scanned at 10 minutes, 1 hour and 2 hours post injection

Locations

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

Sponsors (2)

Lead Sponsor	Collaborator
Rigshospitalet, Denmark	Curasight

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 J — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biodistribution	The patients will be PET scanned 10 minutes, 1 hour and 2 hours post injection of the radiotracer 68Ga-NOTA-AE105. These timepoints will be used for assessment of biodistribution	2 hours	No
Primary	Dosimetry	The patients will be PET scanned 10 minutes, 1 hour and 2 hours post injection of the radiotracer 68Ga-NOTA-AE105. These timepoints will be used for calculation of dosimetry with the use of OLINDA/EXM software (mSv)	2 hours	No
Primary	Safety	the patients will be monitored for safety (occurence of adverse events, vital signs, blood test parameters) following injection of the radiotracer 68Ga-NOTA-AE105	2 hours	Yes
Secondary	Quantitative uptake of the radiotracer in tumor tissue	The patients will be PET scanned 10 minutes, 1 hour and 2 hours post injection of the radiotracer 68Ga-NOTA-AE105. These timepoints will be used for assessment of tumor uptake	2 hours	No