Clinical Translation of a Novel Albumin-Binding PET Radiotracer 68Ga-NEB
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT02496013|
Recruitment Status : Recruiting
First Posted : July 14, 2015
Last Update Posted : April 7, 2017
|Condition or disease||Intervention/treatment||Phase|
|Arteriovenous Malformation Hemangioma Neoplasms Lymph Nodes Lymphedema||Drug: 68Ga-NEB||Phase 1|
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 (Clinical Trial)|
|Estimated Enrollment :||70 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
|Study Start Date :||January 2014|
|Estimated Primary Completion Date :||December 2017|
|Estimated Study Completion Date :||December 2017|
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.
68Ga-NEB were injected into the patients before the PET/CT scans
Other Name: 68Ga-NOTA conjugated truncated form of Evans blue
- Biodistribution of 68Ga-NEB as determined by standardized uptake value for PET imaging [ Time Frame: 1 years ]
- Adverse events collection [ Time Frame: 2 week ]Adverse events within 2 weeks after the injection and scanning of healthy volunteers and patients will be followed and assessed
- Routine blood test [ Time Frame: 24 hours ]Routine blood test of healthy volunteers will be measured before injection and 24 hours after test
- Serum albumin [ Time Frame: 24 hours ]Serum albumin of healthy volunteers will be measured before injection and 24 hours after test
- Routine urine test [ Time Frame: 24 hours ]Routine urine test of healthy volunteers will be measured before injection and 24 hours after test
- Assessment of liver lesions as determined by standardized uptake value of 68Ga-NEB PET [ Time Frame: 2 years ]
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02496013
|Contact: Zhaohui Zhu, Dr.||+86 10 email@example.com|
|Contact: Jingjing Zhang, Dr.||+86 firstname.lastname@example.org|
|Beijing, Beijing, China, 100730|
|Contact: Jingjing Zhang, Dr. +86 15101033017 email@example.com|
|Principal Investigator: Fang Li, Dr.|
|Study Chair:||Fang Li, Dr.||Peking Union Medical College Hospital|