Actively Recruiting
68Ga/177Lu-PSMA Theranostics in Recurrent Grade 3 and Grade 4 Glioma
Led by St. Olavs Hospital · Updated on 2025-06-05
10
Participants Needed
1
Research Sites
139 weeks
Total Duration
On this page
Sponsors
S
St. Olavs Hospital
Lead Sponsor
N
Norwegian University of Science and Technology
Collaborating Sponsor
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
68Ga/177Lu-PSMA Theranostics in Recurrent Grade 3 and Grade 4 Glioma
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed diagnosis of WHO grade 3 or grade 4 glioma
- MRI confirmed tumor relapse or progression at least 12 weeks after completed radiotherapy or suspicion of recurrence
- 18 years of age or older
- Provided written informed consent
- Negative pregnancy test within 14 days before enrollment
- Life expectancy greater than 12 weeks
- Karnofsky performance status of 70% or higher (able to care for self after radionuclide therapy)
- High tumor uptake on 68Ga-PSMA diagnostic imaging
- Tumor not suitable for radiotherapy or surgery, with no preferable systemic therapy options per treating oncologist
- Women of childbearing potential must use adequate contraception unless permanently sterile
- Willing to avoid other tumor-directed treatments for at least 8 weeks after each 177Lu-PSMA injection
You will not qualify if you...
- Estimated glomerular filtration rate (GFR) less than 30 mL/min
- Platelet count below 75 x 10^9/L
- White blood cell count 2.5 x 10^9/L or less
- Neutrophil count less than 1.5 x 10^9/L
- Hemoglobin below 8.0 g/dL
- Albumin 25 g/L or less
- Uncontrollable symptomatic epilepsy not responding to standard medication
- Pacemakers or defibrillators incompatible with 3T MRI
- Inability to provide informed consent due to cognitive or speech impairments
- Breastfeeding or pregnancy
- Allergy to the active substance or any excipients
- Urinary or fecal incontinence requiring diapers
- Significant medical or psychiatric illness compromising therapy tolerance
- Previous radiotherapy or radionuclide therapy resulting in high absorbed doses to kidneys or parotids unless individually assessed
- Use of investigational drugs or experimental therapy within 4 weeks prior to study
- Unwillingness to accept potential dry mouth (xerostomia)
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
St. Olavs hospital
Trondheim, Norway
Actively Recruiting
Research Team
T
Tora Solheim, MD/PhD
CONTACT
L
Live Eikenes, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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