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

• Sponsor: Rigshospitalet, Denmark (Other)
• Overall Status: Completed
• CT.gov ID: NCT02437539
• Collaborator: Curasight (Other)
• Enrollment: 10
• Location: 1
• Arm: 1
• Duration (Months): 3
• Patients Per Site Per Month: 3.3

Study Details

Study Description

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).

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer; Prostate Cancer; Urinary Bladder Cancer	Drug: Injection of 68Ga-NOTA-AE105; Device: Positron Emission Tomography scans	Phase 1

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).

Study Design

• Study Type: Interventional
• Actual Enrollment: 10 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• 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
• Study Start Date: May 1, 2015
• Actual Primary Completion Date: Aug 1, 2015
• Actual Study Completion Date: Aug 1, 2015

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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	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

Outcome Measures

Primary Outcome Measures

1. Biodistribution [2 hours]

   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. Dosimetry [2 hours]

   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)

3. Safety [2 hours]

   the patients will be monitored for safety (occurence of adverse events, vital signs, blood test parameters) following injection of the radiotracer 68Ga-NOTA-AE105

Secondary Outcome Measures

1. Quantitative uptake of the radiotracer in tumor tissue [2 hours]

   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

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 80 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet	Copenhagen		Denmark	2100

Sponsors and Collaborators

• Rigshospitalet, Denmark
• Curasight

Investigators

• Principal Investigator: Dorthe Skovgaard, MD, PhD, Rigshospitalet, Denmark

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Dorthe Skovgaard, MD, Phd, Rigshospitalet, Denmark
• ClinicalTrials.gov Identifier: NCT02437539
• Other Study ID Numbers: 2014-730; 2014-005522-35
• First Posted: May 7, 2015
• Last Update Posted: Aug 24, 2015
• Last Verified: Aug 1, 2015

• Additional relevant MeSH terms: Urinary Bladder Neoplasms

Study Results

No Results Posted as of Aug 24, 2015