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

NCT ID: NCT05140083

Last Updated: 2023-09-21

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE1

Total Enrollment

80 participants

Study Classification

INTERVENTIONAL

Study Start Date

2021-04-25

Study Completion Date

2024-12-30

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.

Conditions

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Positron-Emission Tomography

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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

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.

Group Type EXPERIMENTAL

68Ga-NOTA Evans Blue

Intervention Type DRUG

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

Interventions

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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.

Intervention Type DRUG

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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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First Affiliated Hospital of Fujian Medical University

OTHER

Sponsor Role lead

Responsible Party

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Weibing Miao, PhD

Director, Department of Nuclear Medicine

Responsibility Role PRINCIPAL_INVESTIGATOR

Locations

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Department of Nuclear Medicine, First Affiliated Hospital of Fujian Medical University

Fuzhou, Fujian, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Weibing Miao, MD

Role: CONTACT

86-0591-87981618

Meiyan Lin, MD

Role: CONTACT

86-0591-87981619

Facility Contacts

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Weibing Miao, MD

Role: primary

+86 591 87981618

Meiyan Lin, MD

Role: backup

+86 591 87981619

Other Identifiers

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FirstAHFujian13

Identifier Type: -

Identifier Source: org_study_id

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