Application of 68Ga NEB PET Imaging in the Diagnosis and Evaluation of Lymphatic Disorders
1 other identifier
interventional
90
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for phase_1
Started Oct 2019
Typical duration for phase_1
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
October 1, 2019
CompletedFirst Submitted
Initial submission to the registry
February 15, 2020
CompletedFirst Posted
Study publicly available on registry
February 18, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2022
CompletedFebruary 18, 2020
February 1, 2020
3.3 years
February 15, 2020
February 15, 2020
Conditions
Outcome Measures
Primary Outcomes (1)
Standardized uptake value of 68Ga NEB in lymphatic lesion
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.
1 years
Secondary Outcomes (1)
Adverse events collection
1 week
Study Arms (1)
68Ga-NEB injection and PET/CT scan
EXPERIMENTALPatients for lymphatic disorders imaging: The patients were subcutaneously injected with 68Ga-NEB and underwent PET/CT scan 20\~40min after the injection.
Interventions
68Ga-NEB were injected into the patients before the PET/CT scans
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
Beijing, Beijing Municipality, 100730, China
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY CHAIR
Zhaohui Zhu, MD,PhD
Peking Union Medical College Hospital
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- phase 1
- Allocation
- NA
- Masking
- NONE
- Purpose
- DIAGNOSTIC
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
February 15, 2020
First Posted
February 18, 2020
Study Start
October 1, 2019
Primary Completion
December 31, 2022
Study Completion
December 31, 2022
Last Updated
February 18, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share