Immuno-Positron Emission Tomography (PET)-Glioma Study, a Proof-of-principle Imaging Study

NCT05753995 | Active Not Recruiting

• 1 other identifier: Immuno-PET-Glioma study
• Study Type: interventional
• Target: 20
• Locations: 1 country
• Sites: 1

Brief Summary

Imaging of proinflammatory activated microglia by Purine 2X7 (P2X7) receptor scintigraphy in Positron Emission Tomography (PET) scanner in Glioblastoma patients.

Conditions

Glioblastoma

Outcome Measures

Primary Outcomes (1)

• Immuno PET can be used to visualize the immunological environment of the tumor (Glioblastoma).

  Thus, the aim of the pilot study, which follows an exploratory approach, is to evaluate PET imaging in vivo in patients using PET ligand \[18F\]JNJ-64413739 or a \[18F\] labeled equivalent. To evaluate if it is possible to visualize (visually topically deniable increased Tracer-uptake) the immunological processes in tumor or adjacent brain structures in sufficient image quality. We practice measurement by SUV (= standard uptake value) of the morphologically identified glioblastoma lesion relative to normal brain tissue: TBR (=tumor background ratio) - as a quantification of immunological processes inside the tumor.

  1-2 years

Study Arms (1)

single arm

OTHER

for diagnostic

Diagnostic Test: PET imaging

Interventions

PET imaging DIAGNOSTIC_TEST

The evaluation of PET imaging using PET ligand \[18F\]JNJ-64413739 or a \[18F\] labeled equivalent in vivo in patients.

single arm

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients with a new probable diagnosis of glioblastoma based on MRI imaging.
• prior to initiation of specific tumor therapy and prior to any surgery (including biopsy)

You may not qualify if:

• Non-business capacity
• Pregnancy
• breastfeeding period
• Other malignant disease (active)
• Concurrent participation in another clinical trial
• Foreseeable compliance problems

Sponsors & Collaborators

• Kepler University Hospital: lead

Study Sites (1)

Kepler University Hospital

Linz, Upper Austria, 4020, Austria

Location

MeSH Terms

Conditions

Glioblastoma

Interventions

Positron-Emission Tomography

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Tomography, Emission-Computed; Image Interpretation, Computer-Assisted; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Image Enhancement; Photography; Radionuclide Imaging; Tomography; Diagnostic Techniques, Radioisotope

Study Officials

• Robert Pichler, PD, MD

  Kepler University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

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

Study Record Dates

• First Submitted: February 23, 2023
• First Posted: March 3, 2023
• Study Start: March 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): December 1, 2026
• Last Updated: April 1, 2025

Record last verified: 2025-03

Locations

AU (1)