JOURNAL ONKOLOGIE – STUDIE

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

Studien-Informationen Einschlusskriterien Studien-Rationale Geprüfte Regime

Rekrutierend

NCT-Nummer:
NCT05753995

Studienbeginn:
März 2024

Letztes Update:
06.03.2024

Wirkstoff:
-

Indikation (Clinical Trials):
Glioblastoma

Geschlecht:
Alle

Altersgruppe:
Erwachsene (18+)

Phase:
-

Sponsor:
Kepler University Hospital

Collaborator:
-

Studienleiter

Robert Pichler, PD, MD
Principal Investigator
Kepler University Hospital

Kontakt

Robert Pichler, PD, MD,
Kontakt:
Phone: +435768087
Phone (ext.): 26100
E-Mail: robert.pichler@kepleruniklinikum.at» Kontaktdaten anzeigen

Studienlocations
(1 von 1)

Kepler University Hospital
4020 Linz
AustriaRekrutierend» Google-Maps
Ansprechpartner:
Robert Pichler, PD, MD
Phone: +435768087
Phone (ext.): 26100
E-Mail: robert.pichler@kepleruniklinikum.at

Elke Bach, SC
Phone: +435768087
Phone (ext.): 29215
E-Mail: elke.bach@kepleruniklinikum.at» Ansprechpartner anzeigen

Studien-Informationen

Detailed Description:

Glioblastomas are extremely malignant tumors of the brain; despite different therapeutic

approaches, the median survival is only about 1 ½ years. This makes the need for action to

investigate the mechanisms of action of new drug approaches all the more urgent. In the

therapy of malignant intracerebral neoplasms, immunological processes between tumor and

endogenous immune response represent a key phenomenon for understanding response.

In the CheckMate-143 trial, an anti-programmed cell death-1 monoclonal antibody disappointed

by ineffectiveness in the vast majority of Glioblastoma patients (although a minority

benefited significantly). This will be largely explained by the immunological milieu of the

tumor. One-third of the cells in Glioblastoma constitute the microglia or monocyte cell

population. These immunocompetent cells also serve as a protective shield for the

Glioblastoma against a possible therapy-induced endogenous immune response.

Corresponding research is being conducted preclinically on cell cultures, brain tissue

samples (immunohistochemistry, autoradiography) and in animal models. A major role is played

by microglial cells, which perform the immunocompetent function in the brain. Microglia and

monocytes have an activation state as well as an opposite of a suppressive one in their

immunological function. This M1 or M2 concept is similar to the old postulated Th1 or Th2

principle in lymphocytes. Different purinergic receptors -P2Y12R and Purine receptor 2XR -

are active here, respectively. Recently, antibody-based positron-emitter-labeled tracers have

been developed for this purpose and thus, in principle, positron emission tomography (PET)

imaging in vivo is possible.

The subsequent clinical relevance of a better understanding of these processes would consist

in a combined therapeutic concept, in which additionally an immunomodulation in the desired

direction of the regional activity of the immunocompetent cells could take place.

Methods for in vivo imaging of activated microglia in positron emission computed tomography

scanners (PET) have already been developed - e.g. translocator protein positron emission

tomography (TSPO-PET) by detecting mitochondrial activation of microglial cells. Here,

however, it is not possible to distinguish between pro- and anti-inflammatory function of the

immunocompetent cells. However, it is possible to do so by specific receptor recognition. For

example, the purinergic receptor P2X7 is only expressed during proinflammatory activity. For

this purpose, the positron emission tomography scanners (PET) tracer [18-Fluorine] Johnson &

Johnson (JNJ)-64413739 has been developed in the academic research field. Patient cohort

studies are still pending in this regard. Our intention is to investigate in patients with

untreated Glioblastoma whether effective imaging of immunological disease activity is

possible in this way.

Ein-/Ausschlusskriterien

Inclusion Criteria:

- 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)

- short-term medication for cerebral edema (including corticosteroids) and short-term

administration of antiepileptic drugs are not a reason for exclusion

Exclusion Criteria:

- Non-business capacity

- Pregnancy

- breastfeeding period

- Other malignant disease (active)

- Concurrent participation in another clinical trial

- Foreseeable compliance problems

Studien-Rationale

Primary outcome:

1. Immuno PET can be used to visualize the immunological environment of the tumor (Glioblastoma). (Time Frame - 1-2 years):
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.

Geprüfte Regime

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

Quelle: ClinicalTrials.gov

Sie können folgenden Inhalt einem Kollegen empfehlen:

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

Bitte tragen Sie auch die Absenderdaten vollständig ein, damit Sie der Empfänger erkennen kann.

Die mit (*) gekennzeichneten Angaben müssen eingetragen werden!