Clinical trial · Interventional
Phase I Trial: 68Ga-NODAGA-E(c[RGDyK])2 Positron Emission Tomography for Imaging Angiogenesis in Primary and Metastatic Tumor Lesions in Humans
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
| Neuroendocrine Carcinoma | Neuroendocrine Carcinoma | ONTOLOGY_EXACT | 0.98 |
| Ovarian Cancer | Malignant Ovarian Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Injection of 68Ga-NODAGA-E(c[RGDyK])2 | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-NODAGA-E(c[RGDyK])2 PET
- description
- 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
- interventionNames
- Drug: Injection of 68Ga-NODAGA-E(c[RGDyK])2
Primary outcomes (3)
- measure
- Biodistribution
- timeFrame
- 2 hours
- description
- Change in biodistribution estimated by PET
- measure
- Dosimetry
- timeFrame
- 2 hours
- description
- 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.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 50 Years
- Maximum age
- 85 Years
Show eligibility criteria text
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
References
Publications (0)
Data not yet available