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Completed

NCT Number: NCT05346276

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

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.

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Key information

Conditions

PET/CT Disease Neoplasms Pathologic Processes Pathological Conditions, Signs and Symptoms Tumor hLAG-3

Age range

18 year–90 year

Sex eligibility

All sexes

Study type

Observational

Primary location

The First affiliated hospital of xiamen university

Xiamen, Fujian, 361000, China

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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-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.

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.

Treatment and study plan

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.

Primary outcomes

  1. The concordance between 68Ga-DOTA-hLAG-3 PET/CT and histopathological result in LAG-3 expression

    Time frame: 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 outcomes

  1. Evaluate the inter-tumor heterogeneity

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

The First Affiliated Hospital of Xiamen University

Other

Registry information

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Apr 26, 2022
Registry last updated
Aug 8, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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