drugset / Trial / NCT02970786

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

NCT02970786 ↗

Phase 1 Unknown 10 enrolled Rigshospitalet, Denmark
NaSingle-groupOpen-labelDiagnostic

Summary

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).

Timeline

Start
2016-11
Primary completion
2017-06
Completion
—

Drugs

EvaluationDrugModalityDoseRoute
Subject 68Ga-NODAGA-E[c(RGDyK)]2 Diagnostic / imaging agent 200 mbq —