Phase I Trial: 68Ga-NODAGA-E(c[RGDyK])2 Positron Emission Tomography for Imaging Angiogenesis in Primary and Metastatic Tumor Lesions in Humans
NCT02970786 · Status: UNKNOWN · Phase: PHASE1 · Type: INTERVENTIONAL · Enrollment: 10
Last updated 2016-11-22
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).
Conditions
- Neuroendocrine Carcinoma
- Breast Cancer
- Ovarian Cancer
Interventions
- DRUG
-
Injection of 68Ga-NODAGA-E(c[RGDyK])2
Following one injection of 68Ga-NODAGA-E(c\[RGDyK\])2 the patients will be PET scanned at 10 minutes, 1 hour and 2 hours post injection
Sponsors & Collaborators
-
Rigshospitalet, Denmark
lead OTHER
Study Design
- Allocation
- NA
- Purpose
- DIAGNOSTIC
- Masking
- NONE
- Model
- SINGLE_GROUP
Eligibility
- Min Age
- 50 Years
- Max Age
- 85 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2016-11-30
- Primary Completion
- 2017-06-30
Countries
- Denmark
Study Locations
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