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