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Application of 68Ga NEB PET Imaging in the Diagnosis and Evaluation of Lymphatic Disorders

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ClinicalTrials.gov Identifier: NCT04273334
Recruitment Status : Recruiting
First Posted : February 18, 2020
Last Update Posted : February 18, 2020
Sponsor:
Information provided by (Responsible Party):
Peking Union Medical College Hospital

Brief Summary:
This is an open-label whole-body PET/CT study for investigating the value of 68Ga NEB PET imaging in the diagnosis and evaluation of lymphatic disorders including lymphedema, lymphangioma, lymphangioleiomyomatosis, plastic bronchitis, lymphadenopathy caused by rheumatoid arthritis, etc.

Condition or disease Intervention/treatment Phase
Lymphatic Disorders Drug: 68Ga-NEB Phase 1

Detailed Description:

No fasting, hydration or other specific preparation was requested on the day of imaging.

Patients for lymphatic drainage disorders imaging underwent whole-body PET/CT acquisitions 20-40 min after subcutaneously injected into first and second interdigital spaces of both feet or hands of 74-111 MBq (2-3 mCi) 68Ga-NEB with each bed position lasted for 2 min.

A MIM workstation was used for post-processing. The visual method was used to evaluate the lymphatic system, including the morphology and the distribution of the lymphatic system. Semiquantitative methods were applied for image analysis.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 90 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Application of 68Ga NEB PET Imaging in the Diagnosis and Evaluation of Lymphatic Disorders, Including Lymphedema, Lymphangioma, Lymphangioleiomyomatosis, Plastic Bronchitis, Lymphadenopathy Caused by Rheumatoid Arthritis, Etc.
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : December 31, 2022
Estimated Study Completion Date : December 31, 2022


Arm Intervention/treatment
Experimental: 68Ga-NEB injection and PET/CT scan
Patients for lymphatic disorders imaging: The patients were subcutaneously injected with 68Ga-NEB and underwent PET/CT scan 20~40min after the injection.
Drug: 68Ga-NEB
68Ga-NEB were injected into the patients before the PET/CT scans
Other Name: 68Ga-NOTA-Even's Blue




Primary Outcome Measures :
  1. Standardized uptake value of 68Ga NEB in lymphatic lesion [ Time Frame: 1 years ]
    The semiquantitative analysis will be performed by the same person for all the cases, and the standardized uptake value (SUV) of the tracer in lymphatic lesion will be measured.


Secondary Outcome Measures :
  1. Adverse events collection [ Time Frame: 1 week ]
    Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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 lymphatic system lesion(s). In suspicion of lymphedema, lymphangioma, lymphangioleiomyomatosis, plastic bronchitis, lymphadenopathy caused by rheumatoid arthritis, etc.

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): NCT04273334


Contacts
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Contact: Guozhu Hou, MD +86 15611145656 15611145656@163.com

Locations
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China, Beijing
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College Recruiting
Beijing, Beijing, China, 100730
Contact: Guozhu Hou, MD    +86 15611145656    15611145656@163.com   
Sponsors and Collaborators
Peking Union Medical College Hospital
Investigators
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Study Chair: Zhaohui Zhu, MD,PhD Peking Union Medical College Hospital

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Responsible Party: Peking Union Medical College Hospital
ClinicalTrials.gov Identifier: NCT04273334    
Other Study ID Numbers: PekingUMCH-NM26
First Posted: February 18, 2020    Key Record Dates
Last Update Posted: February 18, 2020
Last Verified: February 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Lymphatic Diseases