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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

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05644080). StuddyBuddy aggregates publicly available trial information.