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Completed
NCT05644080
68Ga/177Lu-PSMA Theranostics in Recurrent Grade 3 and Grade 4 Glioma
Conditions: High Grade Glioma
Sex: All
Ages: 18 Years – N/A
Healthy volunteers: No
Phase: NA
Enrollment: 10
Sponsor: St. Olavs Hospital
Location: St. Olavs hospital Trondheim
Summary
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.
Eligibility Criteria
Inclusion Criteria:
* 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.
Exclusion Criteria:
* Estimated GFR \< 30 mL/min
* Platelet count \=23 Gy to any of the kidneys, or \>= 25 Gy to any of the parotids, an individual assessment will be made by the nuclear medicine physician and medical physicist if patient can be included to the therapy part of the study.
* Concurrent investigational drugs or experimental therapy must be stopped at least 4 weeks prior to study entry
* Unwilling to accept potential challenge with xerostomia
Source: ClinicalTrials.gov (NCT05644080). StuddyBuddy aggregates publicly available trial information.