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

Phase

Condition

Hemangioma

Birth Defects

Lymphedema

Treatment

N/A

Clinical Study ID

NCT02496013

PUMCHNM007

ZIAEB000073

Ages > 18
All Genders
Accepts Healthy Volunteers

Study 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.

Eligibility Criteria

Inclusion

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 ofarteriovenous malformations. Newly diagnosed breast cancer and lymph node metastasisis not clear. The tumor will be surgically removed and histological diagnosis will beavailable. Evaluation of cardiac function.

Exclusion

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, radiationphobia, etc.
Concurrent severe and/or uncontrolled and/or unstable other medical disease that, inthe opinion of the investigator, may significantly interfere with study compliance.

Study Design

January 01, 2014

December 31, 2017

Study 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.

Connect with a study center

PET centre
Beijing, Beijing 100730
China
Active - Recruiting

Not the study for you?

Let us help you find the best match. Sign up as a volunteer and receive email notifications when clinical trials are posted in the medical category of interest to you.