TheranosticTrials.org

Clinical Trial · NCT05798273

(68^Ga)-GaPSMA-11 PET/MR-imaging of Malignant Intra-axial Brain Tumors

Overview

PSMA is a transmembrane protein specifically expressed in the vascular endothelium of malignant brain tumors, most notably glioblastoma and not in healthy brain parenchyma. It has been shown to be involved in (neo)angiogenesis and endothelial cell invasion. By means of 68Ga-labeled PSMA ligands, investigators are able to non-invasively visualize/quantify PSMA expression in glioblastoma (neo)vasculature in vivo by means of PET. The primary aim of this study is to confirm PSMA as suitable diagnostic and potential theranostic target in patients with intra-axial brain tumors by means of \[68Ga\]Ga-PSMA-HBEC-CC (\[68Ga\]Ga-PSMA-11) PET. The secondary aim is to assess whether uptake is increased with intra-arterial injection in those tumors that show uptake after intravenous injection of \[68Ga\]Ga-PSMA-11.

Sponsor

Erasmus Medical Center

Phase

N/A

Contacts

Sophie EM Veldhuijzen van Zante, Dr (PRINCIPAL_INVESTIGATOR)

ClinicalTrials.gov

NCT05798273

Drug / Compound

PSMA-11

Isotope(s):
Target(s):
  • PSMA
Ligand Class: Small Molecules
Chelator: HBED-CC

Eligibility

Inclusion

  • Good clinical condition (Karnofsky performance status score \>70)
  • Radiologically presumed/histologically confirmed.
  • Planned for (re-)resection
  • glioma (grade II-IV) showing enhancement on post-contrast MRI
  • brain metastases

Exclusion

  • Known allergic reaction to therapeutic radiopharmaceuticals
  • ear or cochlear implants
  • Known severe thrombocytopenia (platelet count 50 x 109/L)
  • Allergic reaction to iodine containing contrast agent
  • tattoos containing metal traces
  • metallic fragments in or near eyes or blood vessels
  • metal plates, wires, screws or rods
  • surgical (brain) clips or staples
  • Known local infection thrombus or distorted anatomy at the puncture site
  • dental fillings and bridges
  • Impaired liver function :AST and ALT \> 2.5 8 ULN
  • Contra-indications for MR imaging:
  • Severe claustrophobia prohibiting PET/MRI scanning
  • Metal implants or fragments of the type which may concentrate radiofrequency fields or cause tissue damage from twisting in a magnetic field:
  • A physical, neurologic or psychological condition preventing the patient to lay still for the duration of the procedure (± 2h)
  • Pregnancy or lactation
  • Known severe coagulopathy (spontaneous prolonged PT with an INR \> 2.5)
  • penile implants
  • eye implants
  • Impaired renal function: eGFR (MDRD) \<30 ml/min/1,73 m2
  • tubal ligation clips
  • Known history of cerebrovascular disease (e.g. ischemic stroke, cerebral hemorrhage)
  • Any psychological, familial, sociological or geographical condition hampering participationContra-indications for PET imaging
  • artificial joints
  • a cardiac implantable electronic device (pacemaker, wires, implantable cardioverter-defibrillator (ICD))
  • non-removable piercing
  • Previous other malignancies, except for any previous malignancy which was treated with curative intent more than 3 years prior to enrollment, and except for adequately controlled limited basal cell carcinoma of the skin, squamous carcinoma of the skin or carcinoma in situ of the cervix
  • a drug pump implant
  • Karnofsky Performance score of less than 70
  • a nerve stimulator
  • metallic cardiac valve(s)
  • In case of the use of anticoagulation: an absolute contra-indication to temporarily stop or bridge the anti-coagulation.
  • Known severe peripheral vascular disease or femoral artery disease, which makes the femoral approach impossible
  • Known allergic reaction to gadolinium-based contrast agentsContra-indications for arterial catheterization: