PET Imaging of LAG-3 Expression

Not Applicable

• Conditions: Tumor, Solid
• Interventions: Diagnostic Test: 68Ga-DOTA-hLAG-3 PET/CT

• Registration Number: NCT05346276
• Lead Sponsor: The First Affiliated Hospital of Xiamen University

Brief Summary

To evaluate the potential usefulness of 68Ga-DOTA-hLAG-3 positron emission tomography/computed tomography (PET/CT) for the evaluation of LAG-3 expression in primary and/or metastatic tumors, compared with histopathological results.

Detailed Description

Participants with cancer underwent 68Ga-DOTA-hLAG-3 PET/CT for an initial assessment. Tumor uptake was quantified by the maximum standard uptake value (SUVmax) and mean SUV (SUVmean). In addition, the LAG-3 expression of lesions was confirmed by histopathological analyzing. The quantitative parameters of 68Ga-DOTA-hLAG-3 PET/CT were compared with histopathological result to evaluate the diagnostic efficacy.

Study Timeline

• Status Verified: 2022-04
• Study Start: 2022-04-06
• Study First Submitted: 2022-04-06
• Study First Submitted QC: 2022-04-20
• Study First Posted: 2022-04-26
• Last Update Submitted: 2022-05-08
• Last Update Posted: 2022-05-12
• Primary Completion: 2024-05-01
• Study Completion: 2024-05-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• (i) adult patients (aged 18 years or order);
• (ii) patients with newly diagnosed or previously treated malignant tumors (supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report);
• (iii) patients who had scheduled 68Ga-DOTA-hLAG-3 PET/CT scans;
• (iv) 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

• (i) patients with non-malignant lesions;
• (ii) patients with pregnancy;
• (iii) the inability or unwillingness of the research participant, parent or legal representative to provide written informed consent.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
68Ga-DOTA-hLAG-3 PET/CT	68Ga-DOTA-hLAG-3 PET/CT	Each participant receives a single intravenous injection of 68Ga-DOTA-hLAG-3, and undergo PET/CT imaging within the specified time.

Primary Outcome Measures

Name	Time	Method
The concordance between 68Ga-DOTA-hLAG-3 PET/CT and histopathological result in LAG-3 expression	30 days	For 68Ga-DOTA-hLAG-3 PET/CT parameter, the maximum standard uptake value (SUVmax) is measured by defining a region of interest (ROI) around the primary tumor. For histopathological results, the level of LAG-3 expression is quantified as low (\<1%), medium (1-49%), and high (\>49%), respectively. Finally, one-way ANOVA tast will be used to test the concordance between 68Ga-DOTA-hLAG-3 PET/CT and histopathological result in LAG-3 expression.

Secondary Outcome Measures

Name	Time	Method
Evaluate the inter-tumor heterogeneity	30 days	For the inter-tumor heterogeneity, the investigators will use the Wilcoxon test to compare the SUVmax values of primary tumor and metastases, which are measured by 68Ga-DOTA-hLAG-3 PET/CT, for indirectly evaluating the inter-tumor heterogeneity.

Trial Locations

Locations (1)

The First affiliated hospital of xiamen university; 🇨🇳 Xiamen, Fujian, China