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

Phase 1

• Conditions: Lymphatic Disorders
• Interventions: Drug: 68Ga-NEB

• Registration Number: NCT04273334
• Lead Sponsor: 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.

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.

Study Timeline

• Study Start: 2019-10-01
• Status Verified: 2020-02
• Study First Submitted: 2020-02-15
• Study First Submitted QC: 2020-02-15
• Last Update Submitted: 2020-02-15
• Study First Posted: 2020-02-18
• Last Update Posted: 2020-02-18
• Primary Completion: 2022-12-31
• Study Completion: 2022-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 90

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-NEB injection and PET/CT scan	68Ga-NEB	Patients for lymphatic disorders imaging: The patients were subcutaneously injected with 68Ga-NEB and underwent PET/CT scan 20\~40min after the injection.

Primary Outcome Measures

Name	Time	Method
Standardized uptake value of 68Ga NEB in lymphatic lesion	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

Name	Time	Method
Adverse events collection	1 week	Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed

Trial Locations

Locations (1)

Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College; 🇨🇳 Beijing, Beijing, China