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Trial record 25 of 245 for:    cardiac CT OR CAT scan OR coronary artery scan | Recruiting, Not yet recruiting, Available Studies | NIH, U.S. Fed

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

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ClinicalTrials.gov Identifier: NCT02496013
Recruitment Status : Recruiting
First Posted : July 14, 2015
Last Update Posted : April 7, 2017
Sponsor:
Collaborator:
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Information provided by (Responsible Party):
Peking Union Medical College Hospital

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.

Condition or disease Intervention/treatment Phase
Arteriovenous Malformation Hemangioma Neoplasms Lymph Nodes Lymphedema Drug: 68Ga-NEB Phase 1

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.


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 70 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
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

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

Drug: 68Ga-NEB
68Ga-NEB were injected into the patients before the PET/CT scans
Other Name: 68Ga-NOTA conjugated truncated form of Evans blue



Primary Outcome Measures :
  1. Biodistribution of 68Ga-NEB as determined by standardized uptake value for PET imaging [ Time Frame: 1 years ]

Secondary Outcome Measures :
  1. 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

  2. Routine blood test [ Time Frame: 24 hours ]
    Routine blood test of healthy volunteers will be measured before injection and 24 hours after test

  3. Serum albumin [ Time Frame: 24 hours ]
    Serum albumin of healthy volunteers will be measured before injection and 24 hours after test

  4. Routine urine test [ Time Frame: 24 hours ]
    Routine urine test of healthy volunteers will be measured before injection and 24 hours after test

  5. Assessment of liver lesions as determined by standardized uptake value of 68Ga-NEB PET [ Time Frame: 2 years ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

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.

Information from the National Library of Medicine

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


Contacts
Contact: Zhaohui Zhu, Dr. +86 10 69154196 13611093752@163.com
Contact: Jingjing Zhang, Dr. +86 15101033017 zhangjingjingtag@163.com

Locations
China, Beijing
PET centre Recruiting
Beijing, Beijing, China, 100730
Contact: Jingjing Zhang, Dr.    +86 15101033017    zhangjingjingtag@163.com   
Principal Investigator: Fang Li, Dr.         
Sponsors and Collaborators
Peking Union Medical College Hospital
National Institute for Biomedical Imaging and Bioengineering (NIBIB)
Investigators
Study Chair: Fang Li, Dr. Peking Union Medical College Hospital

Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT02496013     History of Changes
Other Study ID Numbers: PUMCHNM007
ZIAEB000073 ( U.S. NIH Grant/Contract )
First Posted: July 14, 2015    Key Record Dates
Last Update Posted: April 7, 2017
Last Verified: April 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
Lymphedema
Congenital Abnormalities
Hemangioma
Arteriovenous Malformations
Lymphatic Diseases
Neoplasms, Vascular Tissue
Neoplasms by Histologic Type
Neoplasms
Vascular Malformations
Cardiovascular Abnormalities
Cardiovascular Diseases
Vascular Diseases