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

Positron-Emission Tomography Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05140083
• Other study ID #: FirstAHFujian13
• Status: Recruiting
• Phase: Phase 1
• Start date: April 25, 2021
• Est. completion date: December 30, 2024

Study information

• Verified date: September 2023
• Source: First Affiliated Hospital of Fujian Medical University
• Contact: Weibing Miao, MD
• Phone: 86-0591-87981618
• Email: miaoweibing[@]126.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 80
• Est. completion date: December 30, 2024
• Est. primary completion date: December 30, 2024
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Positron-Emission Tomography

Intervention

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.

Locations

Country	Name	City	State
China	Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University	Fuzhou	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
First Affiliated Hospital of Fujian Medical University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Visual analysis of lymphatic patency	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
Primary	Standardized uptake value (SUV)	Standardized uptake value (SUV) of 68Ga-NEB for each target lesion of subject.	through study completion, an average of 3 years
Secondary	Diagnostic efficacy	The sensitivity of 68Ga-NEB PET/CT and lymphatic SPECT imaging were calculated.	through study completion, an average of 3 years