Skip to content

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

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

Status
UNKNOWN
Phases
Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05140083
Enrollment
80
Registered
2021-12-01
Start date
2021-04-25
Completion date
2024-12-30
Last updated
2023-09-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Positron-Emission Tomography

Keywords

Lymphatic System Related Diseases

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.

Interventions

DRUG68Ga-NOTA Evans Blue

Each subject receives a single subcutaneous injection of 68Ga-NOTA Evans Blue, and undergo PET/CT imaging within the specific time.

Sponsors

First Affiliated Hospital of Fujian Medical University
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Visual analysis of lymphatic patencythrough study completion, an average of 3 yearsThe 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.
Standardized uptake value (SUV)through study completion, an average of 3 yearsStandardized uptake value (SUV) of 68Ga-NEB for each target lesion of subject.

Secondary

MeasureTime frameDescription
Diagnostic efficacythrough study completion, an average of 3 yearsThe sensitivity of 68Ga-NEB PET/CT and lymphatic SPECT imaging were calculated.

Countries

China

Contacts

Primary ContactWeibing Miao, MD
miaoweibing@126.com86-0591-87981618
Backup ContactMeiyan Lin, MD
linmeiyan_1@163.com86-0591-87981619

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026