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

NCT ID: NCT02437539

Last Updated: 2015-08-24

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2015-05-31
• Study Completion Date: 2015-08-31

Brief 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).

Detailed 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).

Conditions

Breast Cancer; Prostate Cancer; Urinary Bladder Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

68Ga-NOTA-AE105 PET

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

Group Type: EXPERIMENTAL

Injection of 68Ga-NOTA-AE105

Intervention Type: DRUG

One injection of 68Ga-NOTA-AE 105

Positron Emission Tomography scans

Intervention Type: DEVICE

Following injection of 68Ga-NOTA-AE105 the patients will be PET scanned at 10 minutes, 1 hour and 2 hours post injection

Interventions

Injection of 68Ga-NOTA-AE105

One injection of 68Ga-NOTA-AE 105

Intervention Type: DRUG

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

Intervention Type: DEVICE

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Curasight

INDUSTRY

Sponsor Role: collaborator

Rigshospitalet, Denmark

OTHER

Sponsor Role: lead

Responsible Party

Dorthe Skovgaard

MD, Phd

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Dorthe Skovgaard, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Rigshospitalet, Denmark

Locations

Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet

Copenhagen, Copenhagen, Denmark

Countries

Denmark

References

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.

Reference Type: RESULT

PMID: 22213823 (View on PubMed)

Other Identifiers

2014-005522-35

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

2014-730

Identifier Type: -

Identifier Source: org_study_id