NCT06604689 AI-guided Prognostication and Cranial Radiotherapy Optimization in EGFR-TKI-treated Non-small Cell Lung Cancer Patients With Baseline Brain Metastases
| NCT ID | NCT06604689 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Fudan University |
| Condition | NSCLC (Advanced Non-small Cell Lung Cancer) |
| Study Type | OBSERVATIONAL |
| Enrollment | 800 participants |
| Start Date | 2024-09-30 |
| Primary Completion | 2025-04-01 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
This is an observational study. You will not receive an experimental treatment; researchers will collect data based on your existing condition or standard treatment.
This trial targets 800 participants in total. It began in 2024-09-30 with a primary completion date of 2025-04-01.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * Pathologically confirmed non-small cell lung cancer; * clinical stage IV (AJCC, 8th edition, 2017); * EGFR sensitive mutations: EGFR L858R, EGFR exon 19 deletion; * age≥18 years old; * KPS score≥70; * brain metastases at diagnosis; * complete systemic imaging (including brain MRI) before third-generation EGFR-TKI treatment; * received standard third-generation EGFR-TKI therapy (monotherapy or combined with brain radiotherapy); * willing to cooperate with the follow-up after third-generation EGFR-TKI treatment; * informed consent of the patient. Exclusion Criteria: * Multiple primary or metastatic tumors (except early skin cancer, cervical carcinoma in situ that has been treated radically, with no recurrence or progression for more than 5 years); * Pregnant or lactating women who, as judged by the investigator, were not candidates for brain MRI; * EGFR sensitive mutations were negative or EGFR mutation status was not detected. * Uncontrolled epilepsy, central nervous system disease, or history of mental disorders, judged by the researcher to potentially interfere with the signing of the informed consent form or affect patient compliance.
Contact & Investigator
Frequently Asked Questions
Who can join the NCT06604689 clinical trial?
This trial is open to participants of all sexes, aged 18 Years or older, studying NSCLC (Advanced Non-small Cell Lung Cancer). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06604689 currently recruiting?
Yes, NCT06604689 is actively recruiting participants. Contact the research team at fuscczzf@163.com for enrollment information.
Where is the NCT06604689 trial being conducted?
This trial is being conducted at Shanghai, China.
Who is sponsoring the NCT06604689 clinical trial?
NCT06604689 is sponsored by Fudan University. The trial plans to enroll 800 participants.
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