Phase I Trial: 68Ga-NODAGA-E(c[RGDyK])2 Positron Emission Tomography for Imaging Angiogenesis in Primary and Metastatic Tumor Lesions in Humans

The primary objective of the trial is to test the new radio tracer 68Ga-NODAGA-E[c(RGDyK)]2 for PET imaging of angiogenesis. The tracer has the potential of identifying tumors with a high level of angiogenesis, which is one of the cancer hallmarks. Furthermore, the tracer can potentially be used in early response assessment to anti-angiogenic treatment.

This is a first-in-man study to test the radio tracer in cancer patients. Safety, biodistribution and dosimetry will be evaluated by repeated PET imaging (10 minutes, 1 hour and 2 hours post injection).

The primary objective of the trial is to test the new radio tracer 68Ga-NODAGA-E[c(RGDyK)]2 for PET imaging of angiogenesis. The tracer has the potential of identifying tumors with a high level of angiogenesis, which is one of the cancer hallmarks. Furthermore, the tracer can potentially be used in early response assessment to anti-angiogenic treatment.

This is a first-in-man study to test the radio tracer in cancer patients. Safety, biodistribution and dosimetry will be evaluated by repeated PET imaging (10 minutes, 1 hour and 2 hours post injection).

The primary end points are safety, biodistribution and dosimetry of 68Ga-NODAGA-E[c(RGDyK)]2. In addition, the quantitative uptake of 68Ga-NODAGA-E[c(RGDyK)]2 will be compared to the expression of integrin αvβ3 measured directly in tumor tissue obtained by surgery or biopsies. The study will be monitored and evaluated in accordance with the principles of Good Clinical Practice (GCP).

Inclusion Criteria:

• Diagnosed with neuroendocrine cancer, breast cancer or ovarian cancer
• Capable of understanding and giving full informed consent

Exclusion Criteria:

• Pregnancy
• Lactation
• Obesity (weight above 140 kg)
• Claustrophobia