Predicting Tumor Metastasis by Employing a Target Organ/Primary Lesion Fusion Radiomics Model
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18-75
SponsorFudan University
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
ECOG performance status score 0-2;
Histologically or cytologically confirmed stage III-IV NSCLC;
If the baseline pathology is adenocarcinoma, driver gene testing (at least EGFR/ALK/ROS1/KRAS/MET) should be performed;
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);
Disqualifiers
Patients with indeterminate pathological type;
Patients without baseline imaging data before treatment;
Baseline imaging examination showed that the corresponding target organ had metastasis (lung cancer/colorectal cancer/breast cancer corresponding to brain/liver/lung metastasis);
patients who cannot or refuse to receive regular imaging follow-up;
Trial population
This study was a prospective observational study. According to the inclusion and exclusion criteria, patients with stage III-IV lung cancer without brain metastasis, colorectal cancer without liver metastasis, and breast cancer without lung metastasis were enrolled. The baseline imaging data and other clinical information were systematically collected, and the enrolled patients were assigned to the high-risk group and the low-risk group according to the radiomics prediction model. The radiomics prediction performance of the previously established metastatic target organ/primary lesion fusion radiomics model for tumor metastasis was regularly followed up and prospectively verified.
Trial design
Design model
Cohort
Time perspective
Prospective
Treatments tested in this trial
Not listed
Trial groups
166 Participants
are grouped into 2 trial groupsGroup A: High risk group
Group B: Low risk group
Trial outcomes
Primary outcomes
1
brain metastasis-free survival, BMFS
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.
Time frame
from enrollment to follow-up.Secondary outcomes
1
1-year/2-year/3-year BMFS rate
1-year/2-year/3-year brain metastasis-free survival rate
Time frame
1-year/2-year/3-year from enrollment2
progression free survival
From date of treatment start until the date of progression or the date of death due to any cause, evaluated according to RECIST 1.1 criteria,
Time frame
Up to 5 years3
overall survival
From date of treatment start to any cause death or last follow-up.
Time frame
From date of treatment start until the date of death from any cause or censored at the last day that the subjects are documented to be alive, whichever came first, assessed up to 5 yearsSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov