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

NCT05644080 | Recruiting DMC

• 1 other identifier: 412811
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

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.

Conditions

High Grade Glioma

Outcome Measures

Primary Outcomes (4)

• Incidence of adverse events

  Type, frequency and severity of adverse events assessed with the Common Terminology Criteria for Adverse Events (CTCAE) version 5.0.

  6 months after end of therapy

• Evaluation of efficacy of 177Lu- PSMA

  Progression free survival (6 months) determined from date of commencement of 177Lu-PSMA therapy

  6 months after commencement of therapy

• Evaluation of efficacy of 177Lu- PSMA

  Overall survival (1 year) determined from date of commencement of 177Lu-PSMA therapy

  1 year after commencement of therapy

• Adverse events

  Change in score in the modified RAI-6 questionnaire.

  Day 1 and 6 months after end of therapy

Secondary Outcomes (9)

• Evaluate radiation dose to tumor and critical organs

  7 days after commencement of therapy

• Tumor response

  8 weeks

• Nano score

  8 weeks

• Health related quality of life

  8 weeks

• Karnofsky performance status

  8 weeks

Study Arms (1)

68Ga/177Lu-PSMA theranostics in recurrent grade 3 and grade 4 glioma

EXPERIMENTAL

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.

Radiation: 177Lu-PSMA I&T

Interventions

177Lu-PSMA I&T 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.

68Ga/177Lu-PSMA theranostics in recurrent grade 3 and grade 4 glioma

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• A previous diagnosis of histologically confirmed WHO grade 3 or grade 4 glioma
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• St. Olavs Hospital: lead
• Norwegian University of Science and Technology: collaborator

Study Sites (1)

St. Olavs hospital

Trondheim, Norway

RECRUITING

Related Publications (1)

• 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.

  PMID: 38968568 DERIVED

MeSH Terms

Conditions

Glioma

Condition Hierarchy (Ancestors)

Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Study Officials

• Tora Solheim, MD/PhD

  St. Olavs hospital/NTNU

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Tora Solheim, MD/PhD

CONTACT

+4772826136; tora.solheim@ntnu.no

Live Eikenes, PhD

CONTACT

+4799568081; live.eikenes@ntnu.no

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Patients with recurrent grade 3 and grade 4 glioma will be recruited for treatment with 177Lu-PSMA.

Study Record Dates

• First Submitted: November 15, 2022
• First Posted: December 9, 2022
• Study Start: March 28, 2023
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: June 5, 2025

Record last verified: 2025-06

Data Sharing

• IPD Sharing: Will not share

Locations

NO (1)