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
|Condition or disease||Intervention/treatment||Phase|
|Lymphatic Disorders||Drug: 68Ga-NEB||Phase 1|
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.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||90 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|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|
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.
68Ga-NEB were injected into the patients before the PET/CT scans
Other Name: 68Ga-NOTA-Even's Blue
- 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.
- 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
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
|Contact: Guozhu Hou, MD||+86 firstname.lastname@example.org|
|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 email@example.com|
|Study Chair:||Zhaohui Zhu, MD,PhD||Peking Union Medical College Hospital|