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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Positron-Emission Tomography

Intervention / Treatment
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* Drug: 68Ga-NOTA Evans Blue


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention 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<br>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<br>* Each subject receives a single subcutaneous injection of 68Ga-NOTA Evans Blue, and undergo PET/CT imaging within the specific time.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 
| 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 Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Lymphatic System Related Diseases