Glioblastoma study: Local
Official title Local, Targeted Therapy With Alpha Emitter [225Ac]Ac-DOTA-SP (TAT) In Newly Diagnosed Glioma (WHO G3-G4)
ClinicalTrials.gov ID: NCT07488754
What this study is testing
- What it's testing
- The study aims to find out if the drug is safe and if it can improve overall survival and time without tumor growth.
- Who it's for
- Adults aged 18‑80 with newly diagnosed WHO grade 3‑4 glioma who have finished first‑line surgery, radiation and chemotherapy and do not need immediate additional surgery.
- What's involved
- Participants will receive up to six local injections of the radioactive agent, plus regular blood tests, neurological exams, imaging and monitoring for side effects.
- Time commitment
- The trial runs for up to three years, with visits for each treatment cycle and periodic follow‑up appointments.
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;
- no sign of progression or radiation necrosis;
- functional state \>70 according to Karnofsky's performance scale (KPS);
You likely can't join if
- low-grade glioma;
- progression or recurrence defined as: deterioration of the patient's condition according to the Karnofsky Performance Scale, worsening of...
- radiation-induced necrosis secondary to radiotherapy; may occur within the first 3 months after radiotherapy (exception: a patient after resection of...
- need for emergency surgery (e.g., acute increase in intracranial pressure);
- significant postoperative complications, e.g., KPS \< 70, wound infection, cerebrospinal fluid leak;
- leak into the ventricular system \>10% during the catheter patency check;
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;
- no sign of progression or radiation necrosis;
- functional state \>70 according to Karnofsky's performance scale (KPS);
- ability to give informed consent to participate in the study.
- low-grade glioma;
- progression or recurrence defined as: deterioration of the patient's condition according to the Karnofsky Performance Scale, worsening of neurological function, progressive neurological deficit, need to initiate or...
- radiation-induced necrosis secondary to radiotherapy; may occur within the first 3 months after radiotherapy (exception: a patient after resection of radiation necrosis - not earlier than 4 weeks post-surgery, after a...
- need for emergency surgery (e.g., acute increase in intracranial pressure);
- significant postoperative complications, e.g., KPS \< 70, wound infection, cerebrospinal fluid leak;
- leak into the ventricular system \>10% during the catheter patency check;
- open/ventricle-connected resection cavity;
- catheter obstruction;
- estimated life expectancy under 3 months;
- patients without preserved logical/verbal contact;
- lack of cooperation from the patient;
- inability to give informed, voluntary consent to participate in the study;
- patients enrolled in another medical trial;
- patients who received any other investigational drug within 1 month prior to the first dose;
- prior treatment with [225Ac]Ac-DOTA-SP;
- breastfeeding or pregnant women;
- severe comorbid organ diseases that, in the Investigator's opinion, significantly increase the procedural risk.
The study team makes the final eligibility decision.
Where it is enrolling
- 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, but 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?
This study is enrolling now at Warsaw, Poland, Poland. Enter your location above to see the nearest enrolling site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool that is independent of the study sponsor. Details come from ClinicalTrials.gov. The study team decides eligibility, and your own doctor gives medical advice.