Predicting tumor spread using a radiomics model

Predicting Tumor Metastasis by Employing a Target Organ/Primary Lesion Fusion Radiomics Model: a Prospective Observational Trial

This study is testing a new way to predict where advanced cancer might spread in patients who haven't shown signs of metastasis yet, to help with earlier diagnosis and treatment.

Quick facts

• Study type: Observational
• Enrollment: 166 (estimated)
• Ages: 18 Years to 75 Years
• Sex: All
• Sponsor: Fudan University (Academic / other)
• Drugs / interventions: chemotherapy, immunotherapy
• Locations: 2 sites (Shanghai, Shanghai Municipality and 1 other locations)
• Trial ID: NCT06202404 on ClinicalTrials.gov

What this trial studies

This observational study aims to validate a radiomics model that predicts tumor metastasis patterns based on the 'soil-seed' theory. The model focuses on common metastasis sites such as the brain for lung cancer, liver for colorectal cancer, and lungs for breast cancer. By analyzing imaging data and patient characteristics, the study seeks to enhance early diagnosis and treatment strategies for metastatic cancer. The research will involve patients with advanced cancer who have not yet shown signs of metastasis.

Who should consider this trial

Good fit: Ideal candidates include patients with stage III-IV non-small cell lung cancer who have not yet developed metastasis and have undergone specific genetic testing.

Not a fit: Patients with indeterminate pathological types or those who already have metastasis at baseline imaging will not benefit from this study.

Why it matters

Potential benefit: If successful, this model could lead to earlier detection and improved treatment strategies for patients at risk of tumor metastasis.

How similar studies have performed: While the approach is based on established theories of tumor behavior, the specific application of this radiomics model for predicting metastasis patterns is novel and has not been extensively tested in prior studies.

Eligibility criteria

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.

Where this trial is running

Shanghai, Shanghai Municipality and 1 other locations

• Fudan University Shanghai Cancer Center — Shanghai, Shanghai Municipality, China (Recruiting)
• Fudan University Shanghai Cancer Center — Shanghai, China (Recruiting)

Study contacts

• Study coordinator: Xiao Chu

Conditions Metastasis; Predictive Cancer Model; metastasis; radiomics; seed and soil theory