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New treatment option for Glioblastoma
Official title Local, Targeted Therapy With Alpha Emitter [225Ac]Ac-DOTA-SP (TAT) in Glioma (WHO G3-G4) Progression
ClinicalTrials.gov ID: NCT06975332
What this study is testing
- What it's testing
- Brain tumors account for 1.35% of all cancers and cause 2.2% of cancer-related deaths. Gliomas are the most common type, comprising 40-90% of central nervous system tumors in different age groups.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 80
You may be able to join if
- 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...
- unifocal lesion;
You likely can't join if
- 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...
- catheter obstruction;
See the full eligibility 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...
- 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.
- 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.
The study team makes the final eligibility decision.
Where it's taking place
- Warsaw, Poland, Poland
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 80 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Warsaw, Poland, Poland. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.