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

NCT ID: NCT04273334

Last Updated: 2020-02-18

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE1
• Total Enrollment: 90 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-10-01
• Study Completion Date: 2022-12-31

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.

Conditions

Lymphatic Disorders

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

68Ga-NEB

Intervention Type: DRUG

68Ga-NEB were injected into the patients before the PET/CT scans

Interventions

68Ga-NEB

68Ga-NEB were injected into the patients before the PET/CT scans

Intervention Type: DRUG

Other Intervention Names

68Ga-NOTA-Even's Blue

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking Union Medical College Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Zhaohui Zhu, MD,PhD

Role: STUDY_CHAIR

Peking Union Medical College Hospital

Locations

Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Countries

China

Central Contacts

Guozhu Hou, MD

Role: CONTACT

15611145656@163.com

+86 15611145656

Facility Contacts

Guozhu Hou, MD

Role: primary

15611145656@163.com

+86 15611145656

Other Identifiers

PekingUMCH-NM26

Identifier Type: -

Identifier Source: org_study_id