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

NCT ID: NCT05346276

Last Updated: 2025-08-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2022-10-10

Study Completion Date

2024-12-13

Brief Summary

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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

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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.

Conditions

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PET/CT hLAG-3 TUMOR

Study Design

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Observational Model Type

OTHER

Study Time Perspective

OTHER

Study Groups

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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

68Ga-DOTA-hLAG-3 PET/CT

Intervention Type DIAGNOSTIC_TEST

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

Interventions

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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.

Intervention Type DIAGNOSTIC_TEST

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The First Affiliated Hospital of Xiamen University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Long Sun, PhD

Role: STUDY_CHAIR

The First Affiliated Hospital of Xiamen University

Locations

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The First affiliated hospital of xiamen university

Xiamen, Fujian, China

Site Status

Countries

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China

Other Identifiers

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XMYY-2022KY041

Identifier Type: -

Identifier Source: org_study_id

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