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

Phase 1

Recruiting

• Conditions: Positron-Emission Tomography
• Interventions: Drug: 68Ga-NOTA Evans Blue

• Registration Number: NCT05140083
• Lead Sponsor: First Affiliated Hospital of Fujian Medical University

Brief Summary

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.

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 Timeline

• Study Start: 2021-04-25
• Study First Submitted: 2021-11-09
• Study First Submitted QC: 2021-11-17
• Study First Posted: 2021-12-01
• Status Verified: 2023-09
• Last Update Submitted: 2023-09-16
• Last Update Posted: 2023-09-21
• Primary Completion: 2024-12-30
• Study Completion: 2024-12-30

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 80

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-NOTA Evans Blue PET/CT in Patients with Lymphatic System Related Diseases	68Ga-NOTA Evans Blue	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.

Primary Outcome Measures

Name	Time	Method
Standardized uptake value (SUV)	through study completion, an average of 3 years	Standardized uptake value (SUV) of 68Ga-NEB for each target lesion of subject.
Visual analysis of lymphatic patency	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.

Secondary Outcome Measures

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

Trial Locations

Locations (1)

Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University; 🇨🇳 Fuzhou, Fujian, China