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The goal of this observational study is to extract the imaging features of brain lesions and primary lung lesions in NSCLC patients with brain metastases by deep learning, as well as common clinicopathological parameters, which are used to construct a multimode model that can accurately predict the treatment efficacy and survival of the third-generation EGFR-TKI treatment, and to use the model to assist in screening high-risk populations suitable for upfront cranial radiotherapy.
Participants receiving third-generation EGFR-TKI treatment will be enrolled in our study and we will collect their regular contrast-enhanced chest CT and contrast-enhanced brain MRI for model construction.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Construction of AI models (retrospective cohort) |
| ||
| Validation of AI models (prospective cohort) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| third-generation EGFR TKIs (Almonertinib/Furmonertinib/Osimertinib) | Drug | EGFR-mutated NSCLC patients with brain metastases who met the inclusion and exclusion criteria, would receive first-line third-generation EGFR-TKI treatment (monotherapy or combined with upfront cranial radiotherapy) |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival (PFS) | The time from the start of EGFR-TKI treatment until the documentation of disease progression or death from any cause, assessed according to the RECIST 1.1 criteria. Patients who are still alive at the time of analysis will have their last contact date used as the cutoff date. | 1 year |
| Measure | Description | Time Frame |
|---|---|---|
| Intracranial Objective Response Rate (iORR) | The percentage of participants in the analysis population whose brain lesions achieve CR or PR, assessed according to the modified RECIST 1.1 criteria. | 1 year |
| Intracranial Progression-Free Survival (iPFS) |
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Inclusion Criteria:
Exclusion Criteria:
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Patients are collected all over china, diagnosed with EGFR-mutant NSCLC with brain metastases.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| zhengfei Zhu | Contact | +86-18017312901 | fuscczzf@163.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Cancer center | Recruiting | Shanghai | Shanghai Municipality | 200050 | China |
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The time from the start of EGFR-TKI treatment until the documentation of intracranial disease progression or death from any cause. If the patients have extracranial disease progression (without intracranial disease progression), the cutoff date was the date of the first occurrence of extracranial disease progression. Patients who have not progressed at the time of analysis will have their last contact date used as the cutoff date. |
| 1 year |
| Overall Survival (OS) | The time from the start of EGFR-TKI treatment until death from any cause. Patients who are still alive at the time of analysis will have their last contact date used as the cutoff date. | 1 year |
| Objective Response Rate (ORR) | The percentage of participants who achieve a Complete Response (CR) or Partial Response (PR) after treatment, assessed according to the RECIST 1.1 criteria. | 1 year |
| ID | Term |
|---|---|
| D002289 | Carcinoma, Non-Small-Cell Lung |
| ID | Term |
|---|---|
| D002283 | Carcinoma, Bronchogenic |
| D001984 | Bronchial Neoplasms |
| D008175 | Lung Neoplasms |
| D012142 | Respiratory Tract Neoplasms |
| D013899 | Thoracic Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D008171 | Lung Diseases |
| D012140 | Respiratory Tract Diseases |
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| ID | Term |
|---|---|
| C000718108 | aumolertinib |
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