NCT06604689Recruiting
AI-guided Prognostication and Cranial Radiotherapy Optimization in EGFR-TKI-treated Non-small Cell Lung Cancer Patients With Baseline Brain Metastases
Artificial Intelligence-guided Prognostication and Cranial Radiotherapy Optimization in First-line Third-generation EGFR-TKI-treated EGFR-mutant Non-small Cell Lung Cancer With Baseline Brain Metastases: a Multicenter, Observational Study
Source: ClinicalTrials.gov · Last updated 12 Nov 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
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.
- Status (registry)
- Recruiting
- Study type
- Observational
- Enrollment
- 800 (estimated)
- First submitted
- 18 Sept 2024
- Start date
- 30 Sept 2024
- Primary completion date
- 1 Apr 2025
- Lead sponsor
- Fudan University
- Diseases
- Lung cancer
- NCT number
- NCT06604689
What you commit to
- Study type: Observational
- Planned participants: 800
- From 30 Sept 2024 to the primary completion date, 1 Apr 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- 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);
- 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.
Lab values
- EGFR sensitive mutations were negative or EGFR mutation status was not detected.
Other
- Pregnant or lactating women who, as judged by the investigator, were not candidates for brain MRI;
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Shanghai Cancer Center Coordinator of this site? Confirm its status | Shanghai | China | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.