Clinical Translation of a Novel Albumin-Binding PET Radiotracer 68Ga-NEB

Study Overview
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Brief Summary
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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.

Detailed Description
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The labeling of albumin has advantages as drawing blood is unnecessary and the operator labeling is not exposed to potentially infectious material. Evans blue (EB) dye has high affinity for serum albumin, The final obtained products NEB (a NOTA conjugate of a truncated form of Evans blue for in vivo albumin labeling) was proceeded strict quality controls. No fasting, hydration or other specific preparation was requested on the day of imaging. Patients for blood pool imaging underwent whole-body PET/CT acquisitions 30-45 min after intravenous injection of 111-148 MBq (3-4 mCi) 68Ga-NEB with each bed position lasted for 2 min and a standard routine 18F-FDG PET/CT within one week. Patients for lymph node imaging including the breast nodules patients underwent a standard routine 18F-FDG PET/CT first, and were locally injected 10 20MBq 68Ga-NEB, followed by dynamic chest regional PET acquisitions. A Siemens MMWP workstation was used for post-processing. Visual analysis was used to determine the general biodistribution and the temporal and intersubject stability. Semiquantitative methods were applied for image analysis.

Official Title
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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

Conditions
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Neoplasms Lymph Nodes, Arteriovenous Malformation, Hemangioma, Lymphedema

Intervention / Treatment
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* Drug: 68Ga-NEB


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: 68Ga-NEB injection and PET/CT scan<br>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. | Drug: 68Ga-NEB<br>* 68Ga-NEB were injected into the patients before the PET/CT scans<br>* Other names: 68Ga-NOTA conjugated truncated form of Evans blue;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Biodistribution of 68Ga-NEB as determined by standardized uptake value for PET imaging |  | 1 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Adverse events collection | Adverse events within 2 weeks after the injection and scanning of healthy volunteers and patients will be followed and assessed | 2 week | 
| Routine blood test | Routine blood test of healthy volunteers will be measured before injection and 24 hours after test | 24 hours | 
| Serum albumin | Serum albumin of healthy volunteers will be measured before injection and 24 hours after test | 24 hours | 
| Routine urine test | Routine urine test of healthy volunteers will be measured before injection and 24 hours after test | 24 hours | 
| Assessment of liver lesions as determined by standardized uptake value of 68Ga-NEB PET |  | 2 years |