Breast Cancer Clinical Trial
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).
;
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Diagnostic
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