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

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.

Study Overview

• Status: Unknown
• Conditions: Lymphedema; Hemangioma; Arteriovenous Malformation; Neoplasms Lymph Nodes
• Intervention / Treatment: Drug: 68Ga-NEB

Detailed 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.

• Study Type: Interventional
• Enrollment (Anticipated): 70
• Phase: Phase 1

Contacts and Locations

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100730
      • Recruiting
      • PET centre
      • Contact: Jingjing Zhang, Dr.; Phone Number: +86 15101033017; Email: zhangjingjingtag@163.com
      • Principal Investigator: Fang Li, Dr.

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: 68Ga-NEB injection and PET/CT scan; 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; 68Ga-NEB were injected into the patients before the PET/CT scans; Other Names: 68Ga-NOTA conjugated truncated form of Evans blue

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Collaborators and Investigators

• Sponsor: Peking Union Medical College Hospital
• Collaborators: National Institute for Biomedical Imaging and Bioengineering (NIBIB)
• Investigators: Study Chair: Fang Li, Dr., Peking Union Medical College Hospital

Study record dates

Study Major Dates

• Study Start: January 1, 2014
• Primary Completion (Anticipated): December 1, 2017
• Study Completion (Anticipated): December 1, 2017

Study Registration Dates

• First Submitted: July 6, 2015
• First Submitted That Met QC Criteria: July 10, 2015
• First Posted (Estimate): July 14, 2015

Study Record Updates

• Last Update Posted (Actual): April 7, 2017
• Last Update Submitted That Met QC Criteria: April 6, 2017
• Last Verified: April 1, 2017

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Cardiovascular Diseases; Vascular Diseases; Neoplasms by Histologic Type; Neoplasms; Lymphatic Diseases; Congenital Abnormalities; Cardiovascular Abnormalities; Neoplasms, Vascular Tissue; Vascular Malformations; Lymphedema; Hemangioma; Arteriovenous Malformations
• Other Study ID Numbers: PUMCHNM007; ZIAEB000073 (U.S. NIH Grant/Contract)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO