PET Imaging of LAG-3 Expression

Tumor, Solid Clinical Trial

Official title:

68Ga-DOTA-hLAG-3 PET Imaging of LAG-3 Expression in Cancers

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05346276
• Other study ID #: XMYY-2022KY041
• Status: Recruiting
• Phase: N/A
• Start date: April 6, 2022
• Est. completion date: May 1, 2024

Study information

• Verified date: April 2022
• Source: The First Affiliated Hospital of Xiamen University
• Contact: Long Sun, PhD
• Phone: 86 0592-2137077
• Email: 13178352662[@]163.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: May 1, 2024
• Est. primary completion date: May 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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.

Related Conditions & MeSH terms

• Tumor, Solid

Intervention

Diagnostic Test:
• 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.

Locations

Country	Name	City	State
China	The First affiliated hospital of xiamen university	Xiamen	Fujian

Sponsors (1)

Lead Sponsor	Collaborator
The First Affiliated Hospital of Xiamen University

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The concordance between 68Ga-DOTA-hLAG-3 PET/CT and histopathological result in LAG-3 expression	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.	30 days
Secondary	Evaluate the inter-tumor heterogeneity	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.	30 days