Clinical trial · Observational
Predicting Tumor Metastasis by Employing a Target Organ/Primary Lesion Fusion Radiomics Model
Predicting Tumor Metastasis by Employing a Target Organ/Primary Lesion Fusion Radiomics Model: a Prospective Observational Trial
NCT06202404CI-TRIAL-00073894recruitingClinicalTrials.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)
A pre-metastatic target organ/primary lesion fusion radiomics model was developed based on the "soil-seed" theory to predict comman tumor metastasis in retrospective settings. To prospectively verify the performance of the target organ/primary lesion fusion radiomics model in predicting tumor metastasis patterns (brain metastasis in lung cancer, liver metastasis in colorectal cancer, lung metastasis in breast cancer), we designed this prospective observational trial.
Conditions
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastasis | — | UNRESOLVED | — |
| Predictive Cancer Model | — | UNRESOLVED | — |
Interventions
Interventions (0)
Data not yet available
No intervention recorded.
Design
Arms and outcomes
Arms (2)
- label
- High risk group
- description
- This is a observational study, patients will be assigned to high-risk or low-risk groups (according to a radiomics model) by the investigators. Both the patients and the treating physicians will be blinded to this procedure. No interventions excluding standard treatment procedure executed by the treating physicians.
- label
- Low risk group
- description
- This is a observational study, patients will be assigned to high-risk or low-risk groups (according to a radiomics model) by the investigators. Both the patients and the treating physicians will be blinded to this procedure. No interventions excluding standard treatment procedure executed by the treating physicians.
Primary outcomes (1)
- measure
- brain metastasis-free survival, BMFS
- timeFrame
- from enrollment to follow-up.
- description
- All patients were followed up regularly for at least 3 years. brain metastasis-free survival (BMFS) between the high-risk group and the low-risk group during follow-up was the primary endpoint. log-rank method was used to calculate the hazard ratio (HR) and 95% confidence interval (CI) of brain metastases between the two groups. If the hazard ratio was less than 0.75 and the upper limit of the 95% confidence interval was less than 1, the study was considered to have met the prespecified end point.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion Criteria: 1. ECOG performance status score 0-2; 2. Histologically or cytologically confirmed stage III-IV NSCLC; 3. If the baseline pathology is adenocarcinoma, driver gene testing (at least EGFR/ALK/ROS1/KRAS/MET) should be performed; 4. Complete imaging data of baseline stage (contrast-enhanced MR For lung cancer, contrast-enhanced MR/CT for colorectal cancer, and chest CT for breast cancer); 5. No target organ metastasis on baseline imaging (no brain/liver/lung metastasis for lung cancer/colorectal cancer/breast cancer, respectively); 6. Patients received at least one systemic therapy (chemotherapy, targeted therapy, immunotherapy, etc.) and received regular follow-up; 7. Regular follow-up during and after treatment; 8. Life expectancy ≥6 months; Exclusion Criteria: 1. Patients with indeterminate pathological type; 2. Patients without baseline imaging data before treatment; 3. Baseline imaging examination showed that the corresponding target organ had metastasis (lung cancer/colorectal cancer/breast cancer corresponding to brain/liver/lung metastasis); 4. patients who cannot or refuse to receive regular imaging follow-up; 5. Combined history of other malignant tumors; 6. Medical examination or clinical findings or other uncontrollable conditions that the investigator considers may interfere with the results or increase the risk of treatment complications for the patient; , 7. Lactating or pregnant women; 8. Receiving other long-term medications that may affect disease progression as assessed by a physician.
References
Publications (1)
- BACKGROUNDChu X, Gong J, Yang X, Ni J, Gu Y, Zhu Z. A "Seed-and-Soil" Radiomics Model Predicts Brain Metastasis Development in Lung Cancer: Implications for Risk-Stratified Prophylactic Cranial Irradiation. Cancers (Basel). 2023 Jan 2;15(1):307. doi: 10.3390/cancers15010307. PMID 36612303