Targeted radiation shows promise for deadly brain tumors
NCT ID NCT05644080
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This pilot study tested a new approach for patients with recurrent high-grade glioma (grade 3 or 4 brain tumors) who have few options left. Researchers used a radioactive drug called 177Lu-PSMA to deliver radiation directly to tumor cells, after first checking if the tumors take up the tracer. Ten participants received up to 6 cycles of therapy, with monitoring for side effects, tumor response, and survival. The goal is to see if this treatment is safe and can improve outcomes for this aggressive cancer.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- 177Lu-PSMA I&T (a radioactive drug that targets PSMA on tumor cells)
- What this could lead to
- If successful, this could offer a new, well-tolerated treatment option for patients with recurrent high-grade glioma, potentially extending survival and improving quality of life.
- What could go wrong
- This is a very small pilot study (10 participants) with no control group, so results may not be generalizable. The treatment may cause side effects from radiation exposure to healthy organs.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Not a phased trial
Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.
- Participants
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10 people
The number who actually took part.
- Started
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Mar 2023
- Finished
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Jul 2025
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 years and older
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * A previous diagnosis of histologically confirmed WHO grade 3 or grade 4 glioma * Radiologically (MRI) confirmed tumor relapse/progression ≥ 12 weeks since completed radiotherapy or suspicion of recurrence where inclusion in the theranostic part of study could be indicated * Must be ≥ 18 years old * Written informed consent for study participation * Negative pregnancy test no longer than 14 days prior to enrollment * Life expectancy \> 12 weeks * Karnofsky performance status ≥ 70% (must be able to care for self after radionuclide therapy) * High tumor uptake on diagnostic imaging with 68Ga -PSMA. * Tumor not amendable for radiotherapy or surgery, and treating oncologist think that there are no other preferable systemic therapy options (e.g temozolomide, PCV or lomustine monotherapy). * Women of childbearing potential (WOCBP) defined as fertile, following menarche and until becoming post-menopausal unless permanently sterile must use adequate contraception. Permanent sterilization methods include hysterectomy, bilateral salpingectomy or bilateral oophorectomy. Adequate contraception in the current study will be the following: o Combined (estrogen and progestogen containing) hormonal contraception associated with inhibition of ovulation: * Intravaginal * transdermal * Progestogen-only hormonal contraception associated with inhibition of ovulation: * oral * injectable * implantable * intrauterine device (IUD) * intrauterine hormone-releasing system ( IUS) * bilateral tubal occlusion * vasectomised partner * sexual abstinence * Patient accept not to receive any other tumor directed treatment before 8 weeks after each 177Lu-PSMA injection. Exclusion Criteria: * Estimated GFR \< 30 mL/min * Platelet count \<75 x109 /L * White blood cells ≤ 2.5 x 109/L * Neutrophil count \< 1.5 x109 /L * Hb \< 8.0 g/dL * Albumin ≤ 25 g/L * Uncontrollable symptomatic epilepsy refractory to standard medication * Pacemakers or defibrillators not compatible with 3T MRI * No ability to obtain informed consent (e.g. due to severe dysphasia or cognitive deficits). * Breastfeeding * Pregnancy * Hypersensitivity to the active substance or to any of the excipients * Urinary and fecal incontinence (patient cannot have diaper needs) * Significant medical or psychiatric illness that, in the investigator's opinion, would compromise the patient's ability to tolerate this therapy * If previous radiotherapy and/or radionuclide therapy have resulted in absorbed doses \>=23 Gy to any of the kidneys, or \>= 25 Gy to any of the parotids, an individual assessment will be made by the nuclear medicine physician and medical physicist if patient can be included to the therapy part of the study. * Concurrent investigational drugs or experimental therapy must be stopped at least 4 weeks prior to study entry * Unwilling to accept potential challenge with xerostomia
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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St. Olavs hospital
Trondheim, Norway
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Other studies related to the condition(s) this trial covers.
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