Arteriovenous Malformation, Hemangioma, Lymphedema, Neoplasms Lymph Nodes
Conditions
Brief 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.
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 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.
Interventions
DRUG68Ga-NEB
68Ga-NEB were injected into the patients before the PET/CT scans
Sponsors
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Peking Union Medical College Hospital
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Biodistribution of 68Ga-NEB as determined by standardized uptake value for PET imaging | 1 years |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Assessment of liver lesions as determined by standardized uptake value of 68Ga-NEB PET | 2 years | — |
| Serum albumin | 24 hours | Serum albumin of healthy volunteers will be measured before injection and 24 hours after test |
| Routine urine test | 24 hours | Routine urine test of healthy volunteers will be measured before injection and 24 hours after test |
| Adverse events collection | 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 | 24 hours | Routine blood test of healthy volunteers will be measured before injection and 24 hours after test |
Countries
China
Contacts
Primary ContactZhaohui Zhu, Dr.
Backup ContactJingjing Zhang, Dr.
Outcome results
None listed