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.
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 Type
INTERVENTIONAL
Allocation
NA
Purpose
TREATMENT
Masking
NONE
Enrollment
10
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.
St. Olavs hospital
Trondheim, Norway
RECRUITINGIncidence of adverse events
Type, frequency and severity of adverse events assessed with the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.
Time frame: 6 months after end of therapy
Evaluation of efficacy of 177Lu- PSMA
Progression free survival (6 months) determined from date of commencement of 177Lu-PSMA therapy
Time frame: 6 months after commencement of therapy
Evaluation of efficacy of 177Lu- PSMA
Overall survival (1 year) determined from date of commencement of 177Lu-PSMA therapy
Time frame: 1 year after commencement of therapy
Adverse events
Change in score in the modified RAI-6 questionnaire.
Time frame: Day 1 and 6 months after end of therapy
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.
Time frame: 7 days after commencement of therapy
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.
Time frame: 8 weeks
Nano score
Neurologic exam (nano score)
Time frame: 8 weeks
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Health related quality of life
Health-related quality of life EQ-5D scores
Time frame: 8 weeks
Karnofsky performance status
Karnofsky performance status
Time frame: 8 weeks
PSMA uptake versus progression free survival
Correlate 68Ga-PSMA uptake (SUV) to overall and image-based progression free survival.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks
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.
Time frame: 8 weeks