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 @ 4:41 PM
Ignite Modification Date:
2025-12-24 @ 4:41 PM
NCT ID:
NCT05095766
Eligibility Criteria:
Inclusion Criteria:
* Male or female over 18 years of age;
* Having undergone gamma knife radiosurgery for brain metastasis;
* Presenting for a first MRI follow-up (Cohort C1);
* Presence of one or more brain metastases with increased enhancement on follow-up MRI (Cohort C2.1 and C2.2); A participant recruited for Cohort C1 could be recruited for follow-up in Cohort C2.1 or C2.2 if the MRI result is ambiguous.
Exclusion Criteria:
* Pregnancy or breastfeeding;
* Other condition that may influence the imaging result;
* Renal impairment (\<30 mL/min/1.73 m2). This threshold is consistent with recent RAC recommendations; Note: For participants with intermediate renal clearance (30-60 mL/min/1.73 m2), the total gadobutrol dose injected is set at the manufacturer's recommended clinical dose. For patients with renal clearance greater than 60 mL/min/1.73 m2, a dose of 1.5x the normal dose is used. These dose values have been approved by Dr. Chénard and are consistent with the RAC recommendations.
* Inability to maintain supine position for the required duration (variable, depending on the sequence);
* Patients who have previously received full brain irradiation;
* Patients who are claustrophobic and cannot tolerate insertion into the MRI scanner;
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT05095766
Study Brief:
Protocol Section:
NCT05095766