Phase I Trial: 68Ga-NODAGA-E(c[RGDyK])2 Positron Emission Tomography for Imaging Angiogenesis in Primary and Metastatic Tumor Lesions in Humans
Study Details
Study Description
Brief 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).
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Phase 1 |
Detailed Description
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).
Study Design
Arms and Interventions
| Arm | Intervention/Treatment |
|---|---|
| Experimental: 68Ga-NODAGA-E(c[RGDyK])2 PET One injection of 68Ga-NODAGA-E(c[RGDyK])2 PET (app. 200 MBq) followed by 3 PET/CT scans 10 minutes, 1 hour and 2 hours post injection |
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
|
Outcome Measures
Primary Outcome Measures
- Biodistribution [2 hours]
Change in biodistribution estimated by PET
- Dosimetry [2 hours]
Dosimetry will be calculated with the use of OLINDA/EXM software (mSv) based on repeated PET imaging with the radiotracer 68Ga-NODAGA-E(c[RGDyK])2.
- Safety of 68Ga-NODAGA-E(c[RGDyK])2 PET as measured by the number of participants with adverse events and significant changes in vital signs, electrocardiogram, and laboratory data. [48 hours]
Secondary Outcome Measures
- Quantitative uptake of the radiotracer 68Ga-NODAGA-E(c[RGDyK])2 in tumor tissue [2 hours]
The patients will be PET scanned 10 minutes, 1 hour and 2 hours post injection of the radiotracer 68Ga-NODAGA-E(c[RGDyK])2. These timepoints will be used for assessment of tumor uptake by the use of maximum and mean standardized uptake value (SUV).
Eligibility Criteria
Criteria
Inclusion Criteria:
-
Diagnosed with neuroendocrine cancer, breast cancer or ovarian cancer
-
Capable of understanding and giving full informed consent
Exclusion Criteria:
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Pregnancy
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Lactation
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Obesity (weight above 140 kg)
-
Claustrophobia
Contacts and Locations
Locations
| Site | City | State | Country | Postal Code | |
|---|---|---|---|---|---|
| 1 | Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet | Copenhagen | Denmark | 2100 |
Sponsors and Collaborators
- Rigshospitalet, Denmark
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
None provided.- AK-2015-1