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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02496013
• Other study ID #: PUMCHNM007
• Secondary ID: ZIAEB000073
• Status: Recruiting
• Phase: Phase 1
• First received: July 6, 2015
• Last updated: April 6, 2017
• Start date: January 2014
• Est. completion date: December 2017

Study information

• Verified date: April 2017
• Source: Peking Union Medical College Hospital
• Contact: Zhaohui Zhu, Dr.
• Phone: +86 10 69154196
• Email: 13611093752[@]163.com
• Is FDA regulated: No
• Study type: Interventional

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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 70
• Est. completion date: December 2017
• Est. primary completion date: December 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

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

Intervention

Drug:
• 68Ga-NEB
68Ga-NEB were injected into the patients before the PET/CT scans

Locations

Country	Name	City	State
China	PET centre	Beijing	Beijing

Sponsors (2)

Lead Sponsor	Collaborator
Peking Union Medical College Hospital	National Institute for Biomedical Imaging and Bioengineering (NIBIB)

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Biodistribution of 68Ga-NEB as determined by standardized uptake value for PET imaging		1 years
Secondary	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
Secondary	Routine blood test	Routine blood test of healthy volunteers will be measured before injection and 24 hours after test	24 hours
Secondary	Serum albumin	Serum albumin of healthy volunteers will be measured before injection and 24 hours after test	24 hours
Secondary	Routine urine test	Routine urine test of healthy volunteers will be measured before injection and 24 hours after test	24 hours
Secondary	Assessment of liver lesions as determined by standardized uptake value of 68Ga-NEB PET		2 years