Clinical trial · Observational
68Ga-DOTA-hLAG-3 PET Imaging of LAG-3 Expression in Cancers
NCT05346276CI-TRIAL-00093306completedClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (3)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| hLAG-3 | — | UNRESOLVED | — |
| PET/CT | — | UNRESOLVED | — |
| TUMOR | Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 68Ga-DOTA-hLAG-3 PET/CT | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- label
- 68Ga-DOTA-hLAG-3 PET/CT
- description
- Each participant receives a single intravenous injection of 68Ga-DOTA-hLAG-3, and undergo PET/CT imaging within the specified time
- interventionNames
- Diagnostic Test: 68Ga-DOTA-hLAG-3 PET/CT
Primary outcomes (1)
- measure
- The concordance between 68Ga-DOTA-hLAG-3 PET/CT and histopathological result in LAG-3 expression
- timeFrame
- 30 days
- description
- 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)
- measure
- Evaluate the inter-tumor heterogeneity
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
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.
References
Publications (0)
Data not yet available
No reference posted for this study.