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| ID | Type | Description | Link |
|---|---|---|---|
| ZIAEB000073 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute for Biomedical Imaging and Bioengineering (NIBIB) | NIH |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 68Ga-NEB injection and PET/CT scan | Experimental | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 68Ga-NEB | Drug | 68Ga-NEB were injected into the patients before the PET/CT scans |
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| Measure | Description | Time Frame |
|---|---|---|
| Biodistribution of 68Ga-NEB as determined by standardized uptake value for PET imaging | 1 years |
| Measure | Description | Time Frame |
|---|---|---|
| Adverse events collection | Adverse events within 2 weeks after the injection and scanning of healthy volunteers and patients will be followed and assessed | 2 week |
| Routine blood test | Routine blood test of healthy volunteers will be measured before injection and 24 hours after test |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Zhaohui Zhu, Dr. | Contact | +86 10 69154196 | 13611093752@163.com | |
| Jingjing Zhang, Dr. | Contact | +86 15101033017 | zhangjingjingtag@163.com |
| Name | Affiliation | Role |
|---|---|---|
| Fang Li, Dr. | Peking Union Medical College Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PET centre | Recruiting | Beijing | Beijing Municipality | 100730 | China |
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| ID | Term |
|---|---|
| D001165 | Arteriovenous Malformations |
| D006391 | Hemangioma |
| D008209 | Lymphedema |
| ID | Term |
|---|---|
| D054079 | Vascular Malformations |
| D018376 | Cardiovascular Abnormalities |
| D002318 | Cardiovascular Diseases |
| D014652 | Vascular Diseases |
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| ID | Term |
|---|---|
| C000603981 | 68Ga-1,4,7-triazacyclononane-N,N',N''-triacetic acid |
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| 24 hours |
| Serum albumin | Serum albumin of healthy volunteers will be measured before injection and 24 hours after test | 24 hours |
| Routine urine test | Routine urine test of healthy volunteers will be measured before injection and 24 hours after test | 24 hours |
| Assessment of liver lesions as determined by standardized uptake value of 68Ga-NEB PET | 2 years |
| D000013 | Congenital Abnormalities |
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
| D009383 | Neoplasms, Vascular Tissue |
| D009370 | Neoplasms by Histologic Type |
| D009369 | Neoplasms |
| D008206 | Lymphatic Diseases |
| D006425 | Hemic and Lymphatic Diseases |