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 @ 9:59 PM
Ignite Modification Date:
2025-12-24 @ 9:59 PM
NCT ID:
NCT06975332
Eligibility Criteria:
Inclusion Criteria:
* age 18-80;
* histologically confirmed diffuse glioma (CNS WHO G3-G4);
* after standard treatment with biopsy or resection, radiotherapy and/or chemotherapy;
* tumour progression as defined by RANO 2.0 on MRI (hyperintense lesion on MRI or increase of maximal transverse diameter of tumour or increase on volumetric measurement, local progression by continuity in proximity of 4 cm to primary lesion after resection, stable lesion progression on MRI \>25% in time between two consecutive MRIs or any new lesion on MRI; to differentiate progression from pseudoprogression a biopsy may be needed, especially within 12 weeks from radiotherapy);
* unifocal lesion;
* after resection: tumour volume \<50 ml AND tumour tissue thickness on contrast-enhanced T1 MRI \<1 cm;
* after biopsy: tumour median diameter \<2 cm;
* functional state \>70 according to Karnofsky's performance scale (KPS);
* ability to give informed consent to participate in the study.
Exclusion criteria:
* necessity of urgent surgery (e.g., sudden increase in intracranial pressure);
* significant postoperative complications: e.g., Karnofsky's performance scale (KPS) \<70, wound infection, cerebrospinal fluid leak;
* ventricular shunt leak \>10% during a control patency test;
* open/communicating resection cavity;
* mass effect on CT scan or MRI with midline shift of more than 5 mm and/or nausea, vomiting, altered consciousness, or clinically significant papilledema;
* catheter obstruction;
* predicted life expectancy less than 3 months;
* patients without preserved logical-verbal contact or uncooperative;
* inability to provide informed, voluntary consent to participate in the study;
* patients participating in another medical experiment;
* patients who have taken any other investigational drug within 1 month of the first dose;
* prior treatment with \[225Ac\]Ac-DOTA-SP;
* breastfeeding or pregnancy;
* severe diseases of other organs that, in the opinion of the Investigator, significantly increase the risk of the procedure.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
80 Years
Study:
NCT06975332
Study Brief:
Protocol Section:
NCT06975332