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

Lymphedema Clinical Trial

Official title: 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

Status Recruiting

Clinical Trial Summary

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.

Clinical Trial Description

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. ;

Related Conditions & MeSH terms

• Arteriovenous Malformation
• Arteriovenous Malformations
• Congenital Abnormalities
• Hemangioma
• Lymphedema
• Neoplasms Lymph Nodes

• NCT number: NCT02496013
• Study type: Interventional
• Source: Peking Union Medical College Hospital
• Contact: Zhaohui Zhu, Dr.
• Phone: +86 10 69154196
• Email: 13611093752@163.com
• Status: Recruiting
• Phase: Phase 1
• Start date: January 2014
• Completion date: December 2017