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

Fujian Medical University (FJMU)

Status and phase: Enrolling; Phase 1

Conditions: Positron-Emission Tomography

Treatments: Drug: 68Ga-NOTA Evans Blue

Study type: Interventional

Funder types: Other

Identifiers

NCT05140083

FirstAHFujian13

Details and patient eligibility

About

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.

Full 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.

Enrollment: 80 estimated patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Diagnostic

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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80 participants in 1 patient group

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

Experimental group

Description:

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.

Treatment:

Drug: 68Ga-NOTA Evans Blue