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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).
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-NODAGA-E(c[RGDyK])2 PET | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Injection of 68Ga-NODAGA-E(c[RGDyK])2 | Drug | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Biodistribution | Change in biodistribution estimated by PET | 2 hours |
| Dosimetry | 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. | 2 hours |
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Quantitative uptake of the radiotracer 68Ga-NODAGA-E(c[RGDyK])2 in tumor tissue | 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). | 2 hours |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Malene M Clausen, MD, PhD | Contact | +4522524536 | malene.martini.clausen@regionh.dk | |
| Andreas Kjaer, Professor | Contact | +4535454011 | andreas.kjaer@regionh.dk |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Department of Clinical Physiology, Nuclear Medicine and PET, Rigshospitalet | Recruiting | Copenhagen | 2100 | Denmark |
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| ID | Term |
|---|---|
| D018278 | Carcinoma, Neuroendocrine |
| D001943 | Breast Neoplasms |
| D010051 | Ovarian Neoplasms |
| ID | Term |
|---|---|
| D018358 | Neuroendocrine Tumors |
| D017599 | Neuroectodermal Tumors |
| D009373 | Neoplasms, Germ Cell and Embryonal |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009380 | Neoplasms, Nerve Tissue |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
| D004701 | Endocrine Gland Neoplasms |
| D010049 | Ovarian Diseases |
| D000291 | Adnexal Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D000091662 | Genital Diseases |
| D004700 | Endocrine System Diseases |
| D006058 | Gonadal Disorders |
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