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High Grade GliomaNCT05644080

68Ga/177Lu-PSMA Theranostics in Recurrent Grade 3 and Grade 4 Glioma

A study testing 177Lu-PSMA I&T in people with High Grade Glioma, run by St. Olavs Hospital at 1 site in Norway.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

This interventional, clinical pilot-study will initiate and evaluate 68Ga/177Lu-PSMA theranostics in Norway as treatment alternative for patients with recurrent grade 3 and grade 4 gliomas. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
High Grade Glioma
What is being tested?
177Lu-PSMA I&T
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
10 participants
Where
1 siteNorway
Study dates
28 Mar 2023to 17 Jul 2025
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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
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  • 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.

Who cannot join

  • 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
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  • 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

Trial locations and contacts

1 site in 1 country.

Norway1 site

  • St. Olavs hospital

    Trondheim

Other trials in Norway

About this study

This interventional, clinical pilot-study will initiate and evaluate 68Ga/177Lu-PSMA theranostics in Norway as treatment alternative for patients with recurrent grade 3 and grade 4 gliomas. The main goal is to improve existing diagnostic and therapeutic methods in glioma management, and introduce a novel, well-tolerated radionuclide treatment that possibly can increase the overall survival and quality of life for a patient group that today have very short expected survival and no standard recommended therapy.

Read the detailed description

Patients demonstrating a high tumor uptake of 68Ga-PSMA on the diagnostic PET/MRI examination in the screening part of the study are eligible for a standard of 3 cycles, with a possible extension to maximum number of 6 cycles, of 177Lu-PSMA radionuclide therapy sessions. SPECT/CT will be performed after each cycle of treatment for dosimetry calculations, while 68Ga-PSMA PET/MRI, quality-of-life schemes and clinical examinations will be used to monitor therapeutic effects during the therapy cycles and up to 1.5 year after treatment initiation. The main endpoints of the study are progression-free survival and overall survival.

Being tested
177Lu-PSMA I&T
Medical subject headings
Glioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 177Lu-PSMA I&TRadiation

    Patients demonstrating a high tumor uptake of 68Ga-PSMA on the diagnostic PET/MRI examination in the screening part of the study are eligible for a standard of 3 cycles, with a possible extension to maximum number of 6 cycles, of 177Lu-PSMA radionuclide therapy sessions. SPECT/CT will be performed after each cycle of treatment for dosimetry calculations, while 68Ga-PSMA PET/MRI, quality-of-life schemes and clinical examinations will be used to monitor therapeutic effects during the therapy cycles and up to 1.5 year after treatment initiation. The main endpoints of the study are progression-free survival and overall survival.

Study groups in NCT05644080
Study groupRoleWhat they receive
68Ga/177Lu-PSMA theranostics in recurrent grade 3 and grade 4 gliomaExperimentalPatients demonstrating a high tumor uptake of 68Ga-PSMA on the diagnostic PET/MRI examination in the screening part of the study are eligible for a standard of 3 cycles, with a possible extension to maximum number of 6 cycles, of 177Lu-PSMA radionuclide therapy sessions. SPECT/CT will be performed after each cycle of treatment for dosimetry calculations, while 68Ga-PSMA PET/MRI, quality-of-life schemes and clinical examinations will be used to monitor therapeutic effects during the therapy cycles and up to 1.5 year after treatment initiation. The main endpoints of the study are progression-free survival and overall survival.
Receives: Radiation: 177Lu-PSMA I&T

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Incidence of adverse events

    Type, frequency and severity of adverse events assessed with the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

    Measured: 6 months after end of therapy

  2. Evaluation of efficacy of 177Lu- PSMA

    Progression free survival (6 months) determined from date of commencement of 177Lu-PSMA therapy

    Measured: 6 months after commencement of therapy

  3. Evaluation of efficacy of 177Lu- PSMA

    Overall survival (1 year) determined from date of commencement of 177Lu-PSMA therapy

    Measured: 1 year after commencement of therapy

  4. Adverse events

    Change in score in the modified RAI-6 questionnaire.

    Measured: Day 1 and 6 months after end of therapy

Secondary outcomes (9)

  1. Evaluate radiation dose to tumor and critical organs

    Calculation of absorbed doses to the tumor and kidneys, parotid glands, sublingual glands, submandibular glands, lacrimal glands, liver, spleen and red marrow for each therapy cycle as well as accumulated doses for all therapy cycles.

    Measured: 7 days after commencement of therapy

  2. Tumor response

    Tumor responses as assessed by contrast enhanced MRI according to response assessment in neuro oncology (RANO) criteria (50) (Attachment 3) and volume measurements.

    Measured: 8 weeks

  3. Nano score

    Neurologic exam (nano score)

    Measured: 8 weeks

  4. Health related quality of life

    Health-related quality of life EQ-5D scores

    Measured: 8 weeks

  5. Karnofsky performance status

    Karnofsky performance status

    Measured: 8 weeks

  6. PSMA uptake versus progression free survival

    Correlate 68Ga-PSMA uptake (SUV) to overall and image-based progression free survival.

    Measured: 8 weeks

  7. Pretherapeutic PSMA uptake versus accumulated doses

    Evaluate the possible correlation between the pretherapeutic uptake of 68Ga -PSMA (SUV) in tumors and salivary glands to accumulated doses received from therapeutic 177Lu-PSMA.

    Measured: 8 weeks

  8. Tumor-to-parotis ratio threshold for indication of 177Lu-PSMA therapy

    Establish an appropriate indication for 177Lu-PSMA therapy by measuring tumor:parotis-ratios in 68Ga-PSMA PET scans.

    Measured: 8 weeks

  9. Change in PSMA uptake during treatment period versus overall survival

    Measure changes in uptake (SUV) of 68Ga-PSMA during the treatment period and correlate to overall survival in order to evaluate the role of post-therapeutic 68Ga-PSMA PET in monitoring disease.

    Measured: 8 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted9 Dec 2022
  2. Study start28 Mar 2023
  3. Primary completion11 Apr 2025
  4. Study completion17 Jul 2025

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
Patients with recurrent grade 3 and grade 4 glioma will be recruited for treatment with 177Lu-PSMA.
Masking
None (open label)
Enrolment
10 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05644080
Sponsor's protocol ID
412811
Status last verified
Jun 2026
First submitted
15 Nov 2022
Last updated
18 Jun 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • McBriar JD, Shafiian N, Scharf S, Boockvar JA, Wernicke AG. Prostate-Specific Membrane Antigen Use in Glioma Management: Past, Present, and Future. Clin Nucl Med. 2024 Sep 1;49(9):806-816. doi: 10.1097/RLU.0000000000005365. Epub 2024 Jul 1.

    PubMed 38968568

Questions about this trial

What is this clinical trial studying?

A study testing 177Lu-PSMA I&T in people with High Grade Glioma, run by St. Olavs Hospital at 1 site in Norway.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 23 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 18 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Norway. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Incidence of adverse events (time frame: 6 months after end of therapy). The study lists 4 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05644080, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jun 2026; AzTrials last refreshed its copy on 6 Nov 2026.

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