68Ga-NOTA Evans Blue PET/CT in Patients With Lymphatic System Related Diseases

September 16, 2023 updated by: Weibing Miao, PhD, First Affiliated Hospital of Fujian Medical University
To evaluate the potential usefulness of 68Ga-NOTA Evans Blue (68Ga-NEB) positron emission tomography/computed tomography (PET/CT) for the diagnosis of primary and efficacy assessment in lymphatic system related diseases.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Subjects with lymphatic system related diseases underwent 68Ga-NEB PET/CT either for a primary diagnosis or for efficacy assessment. Anomalies were detected by visual analysis and quantitative analysis of maximum standard uptake value (SUVmax). To compare the diagnostic sensitivity of 68Ga-NEB PET/CT lymphatic imaging with other lymphatic imaging such as 99mTc-dextran for lymphatic system related diseases.

Study Type

Interventional

Enrollment (Estimated)

80

Phase

  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • China
    • Fujian
      • Fuzhou, Fujian, China, 350005
        • Recruiting
        • Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University
        • Contact:
        • Contact:

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • adult population (aged between18 years and 80 years)
  • patients with suspected or new diagnosed or previously treated lymphatic system related diseases
  • patients who had scheduled 68Ga-NEB PET/CT scan
  • patients who were able to provide informed consent (signed by participant, parent or legal representative) and assent according to the guidelines of the Clinical Research Ethics Committee

Exclusion Criteria:

  • patients with pregnancy
  • the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Diagnostic
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: 68Ga-NOTA Evans Blue PET/CT in Patients with Lymphatic System Related Diseases
A single dose of 37-111 Mega-Becquerel (MBq) 68Ga-NOTA Evans Blue will be injected subcutaneously. PET/CT imaging will be performed at 5-30 min post- injection. Visual and quantitative method will be used to assess the PET/CT images.
Drug: 68Ga-NOTA Evans Blue
Each subject receives a single subcutaneous injection of 68Ga-NOTA Evans Blue, and undergo PET/CT imaging within the specific time.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Visual analysis of lymphatic patency
Time Frame: through study completion, an average of 3 years
The bilateral lymphatic description on 68Ga-NEB PET/CT and lymphatic SPECT imaging were compared. The patency of lymphatic vessels (including lymphatic disruption, dermal distribution, and so on, results are indicated by 0 and 1) are shown in two imagings were recorded respectively.
through study completion, an average of 3 years
Standardized uptake value (SUV)
Time Frame: through study completion, an average of 3 years
Standardized uptake value (SUV) of 68Ga-NEB for each target lesion of subject.
through study completion, an average of 3 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Diagnostic efficacy
Time Frame: through study completion, an average of 3 years
The sensitivity of 68Ga-NEB PET/CT and lymphatic SPECT imaging were calculated.
through study completion, an average of 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

First Affiliated Hospital of Fujian Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

April 25, 2021

Primary Completion (Estimated)

December 30, 2024

Study Completion (Estimated)

December 30, 2024

Study Registration Dates

First Submitted

November 9, 2021

First Submitted That Met QC Criteria

November 17, 2021

First Posted (Actual)

December 1, 2021

Study Record Updates

Last Update Posted (Actual)

September 21, 2023

Last Update Submitted That Met QC Criteria

September 16, 2023

Last Verified

September 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • FirstAHFujian13

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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