search
Back to results

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

Primary Purpose

Lymphatic Disorders

Status
Unknown status
Phase
Phase 1
Locations
China
Study Type
Interventional
Intervention
68Ga-NEB
Sponsored by
Peking Union Medical College Hospital
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Lymphatic Disorders

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

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

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

68Ga-NEB injection and PET/CT scan

Arm Description

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

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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

Full Information

First Posted
February 15, 2020
Last Updated
February 15, 2020
Sponsor
Peking Union Medical College Hospital
search

1. Study Identification

Unique Protocol Identification Number
NCT04273334
Brief Title
Application of 68Ga NEB PET Imaging in the Diagnosis and Evaluation of Lymphatic Disorders
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
October 1, 2019 (Actual)
Primary Completion Date
December 31, 2022 (Anticipated)
Study Completion Date
December 31, 2022 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Peking Union Medical College Hospital

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Lymphatic Disorders

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
68Ga-NEB injection and PET/CT scan
Arm Type
Experimental
Arm Description
Patients for lymphatic disorders imaging: The patients were subcutaneously injected with 68Ga-NEB and underwent PET/CT scan 20~40min after the injection.
Intervention Type
Drug
Intervention Name(s)
68Ga-NEB
Other Intervention Name(s)
68Ga-NOTA-Even's Blue
Intervention Description
68Ga-NEB were injected into the patients before the PET/CT scans
Primary Outcome Measure Information:
Title
Standardized uptake value of 68Ga NEB in lymphatic lesion
Description
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.
Time Frame
1 years
Secondary Outcome Measure Information:
Title
Adverse events collection
Description
Adverse events within 1 week after the injection and scanning of patients and patients will be followed and assessed
Time Frame
1 week

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
No
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.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Guozhu Hou, MD
Phone
+86 15611145656
Email
15611145656@163.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Zhaohui Zhu, MD,PhD
Organizational Affiliation
Peking Union Medical College Hospital
Official's Role
Study Chair
Facility Information:
Facility Name
Peking Union Medical College Hospital, Chinese Academy of Medical Science and Peking Union Medical College
City
Beijing
State/Province
Beijing
ZIP/Postal Code
100730
Country
China
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guozhu Hou, MD
Phone
+86 15611145656
Email
15611145656@163.com

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

We'll reach out to this number within 24 hrs