TheranosticTrials.org

Clinical Trial · NCT03903419

Feasibility Study of 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT in Glioblastoma's Patients

Overview

This study is a non-randomized, prospective, multicentric feasibility study assessing 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT to differentiate early recurrence from post-radiation modifications in patients treated with radiotherapy for glioblastoma. Patients with a MRI performed since the end of the radiotherapy until 12 months of follow up after the end of radiotherapy, will be referred for both 68Ga-PSMA and 18F-FDOPA PET-CT, whatever the conclusion of the MRI (post radiation modifications, relapse or doubtful MRI). The rationale of doing 68Ga-PSMA and 18F-FDOPA brain PET-CT in each case will be discussed in detail with the referring physician and an informed consent will be taken from each patient for the study. The two imaging studies will be done at least with a gap of 6 hours, using the same PET-CT scanner.

Sponsor

Centre Leon Berard

Phase

N/A

Contacts

David KRYZA, Pharm.D (CONTACT)

david.kryza@univ-lyon1.fr

+33469856006

Aurélie MOREAU, M.D (PRINCIPAL_INVESTIGATOR)

Aurélie MOREAU, M.D (CONTACT)

aurelie.moreau@lyon.unicancer.fr

+33478782682

ClinicalTrials.gov

NCT03903419

Drug / Compound

FDOPA

Isotope(s):
Target(s):
  • Aromatic L-amino acid decarboxylase (AADC)
Ligand Class: Small Molecules

PSMA-11

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

Eligibility

Inclusion

  • Covered by a medical insurance.
  • Prior treatment with radiation therapy, with or without any concomitant treatment (e.g., chemotherapy).
  • MRI evaluation within the end of radiotherapy to 12 months of follow-up after the end of radiotherapy, with a diagnosis of relapse, or post radiation modifications, or doubt between tumor recurrence or radiation-related complications.
  • Histologically proven glioblastoma.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-3.

Exclusion

  • Patients participating in clinical trials involving isotopic ionizing imaging examinations and/or angiogenic anti-treatment.
  • Pregnancy.
  • Breastfeeding.
  • Adults who are subject to a protective measure or who are unable to express their consent.
  • Patients treated by Avastin within 3 months.