Application of 68Ga-NODAGA-SNA006 Positron Emission Tomography/Computed Tomography (PET/CT) in Tumors

Not Applicable

Active, not recruiting

• Conditions: Cancer
• Interventions: Drug: 68Ga-NODAGA-SNA006

• Registration Number: NCT07059832
• Lead Sponsor: First Hospital of China Medical University

Brief Summary

This is an open-label positron emission tomography/computed tomography (PET/CT) study to investigate the safety and clinical predictive value of 68Ga-NODAGA-SNA006 in subjects with solid tumor or lymphoma.

Detailed Description

The aim of this study was to explore the safety and clinical predictive value of 68Ga-NODAGA-SNA006 in patients with solid tumors or lymphoma.

Study Timeline

• Study Start: 2024-04-01
• Study First Submitted: 2025-06-24
• Status Verified: 2025-07
• Study First Submitted QC: 2025-07-01
• Last Update Submitted: 2025-07-01
• Study First Posted: 2025-07-11
• Last Update Posted: 2025-07-11
• Primary Completion: 2028-01-01
• Study Completion: 2028-04-01

Recruitment & Eligibility

• Status: ACTIVE_NOT_RECRUITING
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

1. Participants who were diagnosed with malignant tumors;
2. Patients are between 18 and 80 years of age are between 18 and 80 years of age.

Exclusion Criteria

1. Participants who were unable or unwilling to provide written informed consent.
2. Participants who were unable to successfully complete the examination and are forced to abort the test in the middle of the test

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Feasibility and safety of 68Ga-NODAGA-SNA006	68Ga-NODAGA-SNA006	68Ga-NODAGA-SNA006 0.05 mCi/Kg, interval time between FDG was within five days

Primary Outcome Measures

Name	Time	Method
Incidence of 68Ga-NODAGA-SNA006-emergent Adverse Events	3 YEAR	Through PET/CT, Visual analysis was positive, or the SUVmax was more than the mediastinum
Biodistribution of 68Ga-NODAGA-SNA006	3 YEAR	Through PET/CT analysis, SUVmax and SUVmean of the organs

Secondary Outcome Measures

Name	Time	Method
Correlation analysis of 68Ga-NODAGA-SNA006 uptake and tumor immune phenotype	3 YEAR	Correlation coefficients (r²) between SUVmax and SUVmean measured by PET/CT and immunophenotypes

Trial Locations

Locations (1)

The First Hospital of China Medical University; 🇨🇳 Shenyang, Liaoning, China