Recurrent grade 3 and grade 4 glioma
Conditions
Brief summary
Evaluation of safety and tolerability: o Type, frequency and severity of adverse events assessed with the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Attachment 1) and change in score in the modified RAI-6 questionnaire (Attachment 2)., Evaluation of efficacy of 177Lu- PSMA: Progression free survival (6 months) and overall survival (1 year) determined from date of commencement of 177Lu-PSMA therapy
Detailed description
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., Evaluate efficacy and side effects of treatment on the following from baseline to end of each treatment cycle and to the follow up examinations: o Tumor responses as assessed by contrast enhanced MRI according to response assessment in neuro oncology (RANO) criteria and volume measurements. o Neurologic exam (nano score) o Health-related quality of life EQ-5D scores o Karnofsky performance status, Evaluate diagnostic and theranostic properties of 68Ga-PSMA
Interventions
Sponsors
Norwegian University Of Science And Technolology
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Evaluation of safety and tolerability: o Type, frequency and severity of adverse events assessed with the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 (Attachment 1) and change in score in the modified RAI-6 questionnaire (Attachment 2)., Evaluation of efficacy of 177Lu- PSMA: Progression free survival (6 months) and overall survival (1 year) determined from date of commencement of 177Lu-PSMA therapy | — |
Secondary
| Measure | Time frame |
|---|---|
| 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., Evaluate efficacy and side effects of treatment on the following from baseline to end of each treatment cycle and to the follow up examinations: o Tumor responses as assessed by contrast enhanced MRI according to response assessment in neuro oncology (RANO) criteria and volume measurements. o Neurologic exam (nano score) o Health-related quality of life EQ-5D scores o Karnofsky performance status, Evaluate diagnostic and theranostic properties of 68Ga-PSMA | — |
Countries
Norway
Outcome results
None listed