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

NCT ID: NCT05644080

Last Updated: 2025-06-05

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: NA
• Total Enrollment: 10 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-03-28
• Study Completion Date: 2025-12-31

Brief 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.

Detailed Description

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.

Conditions

High Grade Glioma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

177Lu-PSMA I&T

Intervention Type: RADIATION

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.

Interventions

177Lu-PSMA I&T

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.

Intervention Type: RADIATION

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 <75 x109 /L
• White blood cells ≤ 2.5 x 109/L
• Neutrophil count < 1.5 x109 /L
• Hb < 8.0 g/dL
• Albumin ≤ 25 g/L
• Uncontrollable symptomatic epilepsy refractory to standard medication
• Pacemakers or defibrillators not compatible with 3T MRI
• No ability to obtain informed consent (e.g. due to severe dysphasia or cognitive deficits).
• Breastfeeding
• Pregnancy
• Hypersensitivity to the active substance or to any of the excipients
• Urinary and fecal incontinence (patient cannot have diaper needs)
• Significant medical or psychiatric illness that, in the investigator's opinion, would compromise the patient's ability to tolerate this therapy
• If previous radiotherapy and/or radionuclide therapy have resulted in absorbed doses >=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

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Norwegian University of Science and Technology

OTHER

Sponsor Role: collaborator

St. Olavs Hospital

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Tora Solheim, MD/PhD

Role: PRINCIPAL_INVESTIGATOR

St. Olavs hospital/NTNU

Locations

St. Olavs hospital

Trondheim, , Norway

Site Status: RECRUITING

Countries

Norway

Central Contacts

Tora Solheim, MD/PhD

Role: CONTACT

tora.solheim@ntnu.no

+4772826136

Live Eikenes, PhD

Role: CONTACT

live.eikenes@ntnu.no

+4799568081

Facility Contacts

Live Eikenes, PhD

Role: primary

References

McBriar JD, Shafiian N, Scharf S, Boockvar JA, Wernicke AG. Prostate-Specific Membrane Antigen Use in Glioma Management: Past, Present, and Future. Clin Nucl Med. 2024 Sep 1;49(9):806-816. doi: 10.1097/RLU.0000000000005365. Epub 2024 Jul 1.

Reference Type: DERIVED

PMID: 38968568 (View on PubMed)

Other Identifiers

412811

Identifier Type: -

Identifier Source: org_study_id