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NCT03903419: PAraDiGM

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

Status unknown NA Last updated 14 October 2020
What this trial tests

NA trial testing Feasibility study for the realization of 68Ga-PSMA PET-CT and 18F-FDOPA PET-CT for identification of early recurrence in patients treated with radiotherapy for glioblastoma. in Glioblastomas in 16 participants. Status unknown.

Timeline
16 January 2019
Primary endpoint
16 August 2021
16 August 2021

Quick facts

Lead sponsorCentre Leon Berard
PhaseNA
StatusStatus unknown
Study typeINTERVENTIONAL
Allocationna
Designsingle group
Maskingnone
Primary purposediagnostic
Enrollment16
Start date16 January 2019
Primary completion16 August 2021
Estimated completion16 August 2021
Sites2 locations across France

Drugs / interventions tested

Conditions studied

Sponsor

Centre Leon Berard — full company profile →

Who can join

18 and older, any sex, with Glioblastomas. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. Novel Tracers and Radionuclides in PET Imaging.
    Mason C, Gimblet GR, Lapi SE, Lewis JS. · · 2021 · cited 10× · PMID 34392925 · DOI 10.1016/j.rcl.2021.05.012
  2. Targeting Glioblastoma Stem Cells: A40s Aptamer-NIR-Dye Conjugate for Glioblastoma Visualization and Treatment.
    Affinito A, Ingenito F, Verde S, Musella E, et al · · 2025 · cited 2× · PMID 40563410 · DOI 10.3390/biom15060768

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