Prostate-Specific Membrane Antigen Use in Glioma Management: Past, Present, and Future.
Joshua D McBriar, Neeva Shafiian, Stephen Scharf...
https://pubmed.ncbi.nlm.nih.gov/38968568Actively Recruiting
Phase Not Applicable
Age: 18Years +
All Genders
ID05644080
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
N/A
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
Researchers are evaluating 68Ga/177Lu-PSMA theranostics as a treatment option for patients in Norway with recurrent grade 3 and grade 4 gliomas, which are aggressive brain tumors. The study aims to improve current diagnostic and treatment methods for glioma patients, focusing on a new radionuclide therapy that may help improve survival and quality of life for patients who currently have limited options and short expected survival. This pilot interventional study seeks to introduce this novel approach in clinical practice. Patients who show high tumor uptake of 68Ga-PSMA on a PET/MRI scan during screening may receive 177Lu-PSMA radionuclide therapy. Participants typically receive three treatment cycles, with the possibility to extend up to six cycles. After each treatment cycle, SPECT/CT scans are used for dosimetry calculations. Throughout the treatment and for up to 1.5 years after starting therapy, researchers will monitor patients with PET/MRI scans, quality-of-life questionnaires, and clinical exams to assess the therapy's effects. Participants will be involved in regular imaging and clinical evaluations, including PET/MRI and SPECT/CT scans, quality-of-life assessments, and performance status checks. Researchers will track progression-free survival, overall survival, and adverse events up to six months after therapy concludes. The study also evaluates radiation doses to tumors and critical organs, tumor response, and changes in PSMA uptake to understand treatment effects and safety over time.
CONDITIONS
Brief Title
68Ga/177Lu-PSMA Theranostics in Recurrent Grade 3 and Grade 4 Glioma
Who Can Participate
Age: 18Years +
All Genders
Eligibility Criteria
You may qualify if you...
- Histologically confirmed WHO grade 3 or grade 4 glioma diagnosis
- MRI confirmed tumor relapse or progression at least 12 weeks after completed radiotherapy or suspicion of recurrence
- At least 18 years old
- Written informed consent for participation
- Negative pregnancy test within 14 days before enrollment
- Life expectancy greater than 12 weeks
- Karnofsky performance status of 70% or higher
- High tumor uptake on 68Ga-PSMA diagnostic imaging
- Tumor not suitable for radiotherapy or surgery and no preferable systemic therapy options
- Women of childbearing potential must use adequate contraception
- Willingness to avoid other tumor-directed treatments within 8 weeks after each 177Lu-PSMA injection
You will not qualify if you...
- Estimated glomerular filtration rate less than 30 mL/min
- Platelet count below 75 x109 /L
- White blood cell count 2.5 x109 /L or lower
- Neutrophil count less than 1.5 x109 /L
- Hemoglobin below 8.0 g/dL
- Albumin 25 g/L or lower
- Uncontrollable symptomatic epilepsy not responsive to medication
- Pacemakers or defibrillators incompatible with 3T MRI
- Unable to provide informed consent due to conditions like severe dysphasia or cognitive deficits
- Currently breastfeeding or pregnant
- Hypersensitivity to the active substance or excipients
- Urinary and fecal incontinence requiring diapers
- Significant medical or psychiatric illness compromising therapy tolerance
- Prior radiotherapy or radionuclide therapy with high absorbed kidney or parotid doses without individual assessment
- Concurrent investigational drugs or experimental therapy within 4 weeks before study entry
- Unwillingness to accept possible xerostomia (dry mouth) challenge from therapy
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 screening and enrollment visit (in-person)
Treatment
Duration - Duration of up to 6 treatment cycles (calendar time varies)
Participants receive up to 3 cycles of 177Lu-PSMA radionuclide therapy, with a possible extension to a maximum of 6 cycles. SPECT/CT scans are performed after each treatment cycle for dosimetry calculations. 68Ga-PSMA PET/MRI, quality-of-life assessments, and clinical examinations are done to monitor therapeutic effects during this period.
1 visit after each treatment cycle for SPECT/CT and assessments
Follow-up
Duration - Up to 1.5 years after treatment initiation
Participants are monitored with 68Ga-PSMA PET/MRI, quality-of-life assessments, and clinical examinations for up to 1.5 years after treatment initiation to evaluate long-term effects and survival outcomes.
Visits scheduled periodically during follow-up for monitoring
Trial Site Locations
Total: 1 location
1
St. Olavs hospital
Trondheim, Norway
Actively Recruiting
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Research Team
T
Tora Solheim, MD/PhD
L
Live Eikenes, PhD
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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