Ignite Creation Date:
2024-05-06 @ 7:13 AM
Last Modification Date:
2024-10-26 @ 11:46 AM
Study NCT ID:
NCT02496013
Status:
UNKNOWN
Last Update Posted:
2017-04-07
First Post:
2015-07-06
Brief Title:
Clinical Translation of a Novel Albumin-Binding PET Radiotracer 68Ga-NEB
Sponsor:
Peking Union Medical College Hospital
Organization:
Peking Union Medical College Hospital
Study Overview
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
Status:
UNKNOWN
Status Verified Date:
2017-04
Last Known Status:
RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This is an open-label whole-body PETCT 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
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 PETCT 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 PETCT within one week
Patients for lymph node imaging including the breast nodules patients underwent a standard routine 18F-FDG PETCT first and were locally injected 1020MBq 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
No fasting hydration or other specific preparation was requested on the day of imaging
Patients for blood pool imaging underwent whole-body PETCT 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 PETCT within one week
Patients for lymph node imaging including the breast nodules patients underwent a standard routine 18F-FDG PETCT first and were locally injected 1020MBq 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 Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| ZIAEB000073 | NIH | None | httpsreporternihgovquickSearchZIAEB000073 |