Overview

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

Status:
Unknown status

Trial end date:
1969-12-31

Target enrollment:
0

Participant gender:
All

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).

Phase:

Phase 1

Accepts Healthy Volunteers?

Details

Lead Sponsor:

Rigshospitalet, Denmark

Criteria

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