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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Not Applicable
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
Norway
St. Olavs hospital
RECRUITING
Trondheim
Contact Information
Primary
Tora Solheim, MD/PhD
tora.solheim@ntnu.no
+4772826136
Backup
Live Eikenes, PhD
live.eikenes@ntnu.no
+4799568081
Time Frame
Start Date: 2023-03-28
Estimated Completion Date: 2025-12
Participants
Target number of participants: 10
Treatments
Experimental: 68Ga/177Lu-PSMA theranostics in recurrent grade 3 and grade 4 glioma
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.
Related Therapeutic Areas
Sponsors
Leads: St. Olavs Hospital
Collaborators: Norwegian University of Science and Technology

This content was sourced from clinicaltrials.gov