Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 7:11 PM
Ignite Modification Date:
2025-12-24 @ 7:11 PM
NCT ID:
NCT07132203
Eligibility Criteria:
Inclusion Criteria:
1. Age 18 years and above;
2. Previously diagnosed or newly diagnosed with a malignant tumor in the body accompanied by intracranial metastasis;
3. The lesion can be clearly identified in the magnetic resonance imaging, and the number of lesions does not exceed 4;
4. The lesion to be treated by ablation has a short axis of ≤ 30mm;
5. Karnofsky Performance Status (KPS) score ≥ 60;
6. The subject or their guardian can understand the purpose of the trial, demonstrate sufficient compliance with the trial protocol, and sign the informed consent form.
Exclusion Criteria:
1. Patients with contraindications for MRI;
2. Patients with severe coagulation dysfunction;
3. Pregnant or lactating women, and those planning to conceive within 6 months;
4. Patients with the longest axis of the maximum brain metastasis lesion less than 5mm;
5. Subjects who have participated in any clinical trials of drugs or medical devices within 3 months before screening;
6. Patients judged by the researcher to be unable to tolerate ablation treatment;
7. Patients judged by the researcher to have evidence of severe or uncontrollable systemic diseases;
8. Subjects considered by the researcher to be unsuitable for this clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT07132203
Study Brief:
Protocol Section:
NCT07132203