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Urogenital Diseases

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Female Urogenital Diseases and Pregnancy Complications

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Plasminogen

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

Injection of 68Ga-NOTA-AE105

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

Positron Emission Tomography scans

Dorthe Skovgaard, MD, PhD

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).

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).

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

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

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

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)

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

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

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization	Link
Evaluation of a New Radiotracer (68Ga-NOTA-AE105) for Diagnosing Aggressive Cancer With Positron Emission Tomography	NCT02437539	Breast Cancer Prostate Cancer Urinary Bladder...	Injection of 68... Positron Emissi...	18 Years - 80 Years	Rigshospitalet, Denmark
Evaluation of a New Radiotracer (68Ga-NOTA-AE105) for Diagnosing Aggressive Cancer With Positron Emission Tomography	NCT02437539	Breast Cancer Prostate Cancer Urinary Bladder...	Injection of 68... Positron Emissi...	18 Years - 80 Years	Rigshospitalet, Denmark

Spots Global Cancer Trial Database for positron emission tomography scans