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Targeted radiation shows promise for deadly brain tumors

NCT ID NCT05644080

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

10 people

The number who actually took part.

Started

Mar 2023

Finished

Jul 2025

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

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

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

  • St. Olavs hospital

    Trondheim, Norway

More trials for these conditions

Other studies related to the condition(s) this trial covers.