Clinical trial · Interventional
Molecular Imaging Visualization of Tumor Heterogeneity in Non-small Cell Lung Cancer
NCT04553601CI-TRIAL-00047210unknownN/AClinicalTrials.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 assess the potential usefulness of radiogenomics for tumor driving genes heterogeneity in non-small cell lung cancer.
Conditions
Conditions (6)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Biopsy | — | UNRESOLVED | — |
| Genomics | — | UNRESOLVED | — |
| NSCLC | Lung Non-Small Cell Carcinoma | ALIAS | 0.90 |
| PET/CT | — | UNRESOLVED | — |
| Radiomics | — | UNRESOLVED | — |
| Whole-exome Sequencing | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| 18F-FDG PET/CT and PET/CT-guide targeted biopsy in another group of participants | Diagnostic Test | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- 8F-FDG PET/CT and PET/CT-guide targeted biopsy
- description
- Each subject receive a single intravenous injection of 18F-FDG PET/CT and PET/CT-guide targeted biopsy within the specified time.
- interventionNames
- Diagnostic Test: 18F-FDG PET/CT and PET/CT-guide targeted biopsy in another group of participants
Primary outcomes (1)
- measure
- Radiomic feature selection and model establishment
- timeFrame
- 3 years
- description
- In this study, the investigators first selected the features with significant differences between genes mutant and wild type in the training set using the Mann-Whitney U test, obtaining a total of 53 features with p value \< 0.05. Then, the least absolute shrinkage and selection operator (LASSO) algorithm was used to select the optimal predictive features among the 53 selected in the training set. The LASSO algorithm adds a L1 regularization term to a least square algorithm to avoid overfitting. A prediction model was established by logistic regression, and the radiomics signature score (rad-score) for each participant was calculated based on the selected discriminating radiomic features. The model performance was tested in the validation set. The receiver operating characteristic (ROC) curve and the area under the curve (AUC) were used to evaluate the model performance in the training and validation sets.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 90 Years
Show eligibility criteria text
Criteria: Inclusion Criteria: * (i) adult patients (aged 18 years or order); * (ii) patients with suspected or 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 both 18F-FDG PET/CT scans and PET/CT guided biopsy; * (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.