Clinical trial · Interventional
Clinical Translation of a Novel Albumin-Binding PET Radiotracer 68Ga-NEB
Radiation Dosimetry, Plasma Pharmacokinetics, Biodistribution, Safety and Diagnostic Performance of 68Ga-NEB in Healthy Volunteers and Patients With Hepatic Space-occupying Lesions and Suspicious Lymph Nodes Metastasis
- 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)
This is an open-label whole-body PET/CT study for investigation of radiation dosimetry, plasma pharmacokinetics, biodistribution, safety and diagnostic performance of 68Ga-NEB in healthy volunteers and patients with suspected infection. Changes of routine blood and urine tests and any adverse events will be collected from the volunteers. Adverse events will also be observed in the patients.
Conditions
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Arteriovenous Malformation | — | UNRESOLVED | — |
| Hemangioma | Hemangioma | ONTOLOGY_EXACT | 0.98 |
| Lymphedema | — | UNRESOLVED | — |
| Neoplasms Lymph Nodes | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-NEB | Drug | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 68Ga-NEB injection and PET/CT scan
- description
- Patients for blood pool imaging: The patients were intravenously injected with 68Ga-NEB and underwent PET/CT scan 30\~45min after the injection. Patients for lymph node imaging: The patients were locally injected 10\~20MBq 68Ga-NEB and followed by dynamic regional PET acquisitions.
- interventionNames
- Drug: 68Ga-NEB
Primary outcomes (1)
- measure
- Biodistribution of 68Ga-NEB as determined by standardized uptake value for PET imaging
- timeFrame
- 1 years
Secondary outcomes (5)
- measure
- Adverse events collection
- timeFrame
- 2 week
- description
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Must be able to provide a written informed consent * Males and females, ≥18 years old； * Diagnostic CT or MRI suggesting a diagnosis of liver focal lesion(s). In suspicion of arteriovenous malformations. Newly diagnosed breast cancer and lymph node metastasis is not clear. The tumor will be surgically removed and histological diagnosis will be available. Evaluation of cardiac function. Exclusion Criteria: * Females planning to bear a child recently or with childbearing potential； * Known severe allergy or hypersensitivity to IV radiographic contrast； * Inability to lie still for the entire imaging time because of cough, pain, etc. * Inability to complete the needed examinations due to severe claustrophobia, radiation phobia, etc. * Concurrent severe and/or uncontrolled and/or unstable other medical disease that, in the opinion of the investigator, may significantly interfere with study compliance.
References
Publications (0)
Data not yet available