Breast Cancer, Neuroendocrine Carcinoma, Ovarian Cancer
Conditions
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).
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).
Interventions
DRUGInjection 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
Rigshospitalet, Denmark
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
50 Years to 85 Years
Healthy volunteers
No
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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). |
Countries
Denmark
Contacts
Primary ContactMalene M Clausen, MD, PhD
Backup ContactAndreas Kjaer, Professor
Outcome results
None listed