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