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

NCT05346276 | Completed DMC

• 1 other identifier: XMYY-2022KY041
• Study Type: observational
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

PET/CT; hLAG-3; TUMOR

Keywords

Tumor; PET/CT; diagnosis; hLAG-3

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Evaluate the inter-tumor heterogeneity

  30 days

Study Arms (1)

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

Diagnostic Test: 68Ga-DOTA-hLAG-3 PET/CT

Interventions

68Ga-DOTA-hLAG-3 PET/CT DIAGNOSTIC_TEST

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

68Ga-DOTA-hLAG-3 PET/CT

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

patients with newly diagnosed or previously treated malignant tumors(supporting evidence may include magnetic resonance imaging (MRI), CT, tumor markers and pathology report)

You may qualify if:

• (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-NK224 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.

You may not qualify if:

• (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.

Sponsors & Collaborators

• The First Affiliated Hospital of Xiamen University: lead

Study Sites (1)

The First affiliated hospital of xiamen university

Xiamen, Fujian, 361000, China

Location

MeSH Terms

Conditions

Neoplasms; Disease

Condition Hierarchy (Ancestors)

Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Long Sun, PhD

  The First Affiliated Hospital of Xiamen University

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 6, 2022
• First Posted: April 26, 2022
• Study Start: October 10, 2022
• Primary Completion: December 13, 2024
• Study Completion: December 13, 2024
• Last Updated: August 8, 2025

Record last verified: 2022-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)