NCT03903419

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
16

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2019

Typical duration for not_applicable

Geographic Reach
1 country

2 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 16, 2019

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

March 28, 2019

Completed
7 days until next milestone

First Posted

Study publicly available on registry

April 4, 2019

Completed
2.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 16, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 16, 2021

Completed
Last Updated

October 14, 2020

Status Verified

October 1, 2020

Enrollment Period

2.6 years

First QC Date

March 28, 2019

Last Update Submit

October 9, 2020

Conditions

Glioblastomas

Outcome Measures

Primary Outcomes (3)

  • Comparison of Maximum Standardized Uptake Values of 68Ga-PSMA and of 18F-FDOPA PET-CT in glioblastomas recurrences and radiation-related complications after radiotherapy.

    Maximum Standardized Uptake Values (SUVmax) of both 68Ga-PSMA and 18F-FDOPA.

    1 week

  • Comparison of Target to Background Ratio of 68Ga-PSMA and of 18F-FDOPA PET-CT in glioblastomas recurrences and radiation-related complications after radiotherapy.

    Target to Background Ratio (TBR) of both 68Ga-PSMA and 18F-DOPA.

    1 week

  • Comparison of Target to Background Ratio and Target to Striatum Ratio of 68Ga-PSMA and of 18F-FDOPA PET-CT in glioblastomas recurrences and radiation-related complications after radiotherapy.

    Target to Background Ratio (TBR) of 68Ga-PSMA and Target to Striatum Ratio of 18F-DOPA.

    1 week

Secondary Outcomes (6)

  • Description of the final diagnosis according to clinical and/or MRI follow-up.

    3 months

  • Concordance between 68Ga-PSMA and 18F-FDOPA PET-CT from visual interpretation.

    1 week

  • PSMA expression on initial glioblastoma sample by immunohistochemistry (IHC).

    3 months

  • Association between PSMA expression and 68Ga-PSMA PET-CT imaging data.

    3 months

  • Association between PSMA expression (IHC) and 68Ga- PSMA PET-CT imaging data. association between PSMA expression and 68Ga-PSMA PET-CT imaging data.

    3 months

  • +1 more secondary outcomes

Study Arms (1)

68Ga-PSMA PET-CT and 18F-FDOPA PET-CT

EXPERIMENTAL

Functional imaging: 68Ga-PSMA and 18F-FDOPA PET-CT Immunohistochemistry of initial chirurgical sample with determination of PSMA expression

Diagnostic Test: 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.

Interventions

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.DIAGNOSTIC_TEST

This study is a non-randomized, prospective, 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).

68Ga-PSMA PET-CT and 18F-FDOPA PET-CT

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Age ≥ 18 years.
  • Histologically proven glioblastoma.
  • 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.
  • Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) of 0-3.
  • Covered by a medical insurance.
  • Signed informed consent.

You may not qualify if:

  • 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.
  • Patients participating in clinical trials involving isotopic ionizing imaging examinations and/or angiogenic anti-treatment.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Hôpital Pierre WERTHEIMER - HCL

Bron, 69677, France

NOT YET RECRUITING

Centre Léon Berard

Lyon, 69008, France

RECRUITING

Related Publications (1)

  • McBriar JD, Shafiian N, Scharf S, Boockvar JA, Wernicke AG. Prostate-Specific Membrane Antigen Use in Glioma Management: Past, Present, and Future. Clin Nucl Med. 2024 Sep 1;49(9):806-816. doi: 10.1097/RLU.0000000000005365. Epub 2024 Jul 1.

    PMID: 38968568DERIVED

MeSH Terms

Conditions

Glioblastoma

Interventions

Radiation

Condition Hierarchy (Ancestors)

AstrocytomaGliomaNeoplasms, NeuroepithelialNeuroectodermal TumorsNeoplasms, Germ Cell and EmbryonalNeoplasms by Histologic TypeNeoplasmsNeoplasms, Glandular and EpithelialNeoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Physical Phenomena

Study Officials

  • Aurélie MOREAU, M.D

    Centre Leon Berard

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Aurélie MOREAU, M.D

CONTACT

+33478782682aurelie.moreau@lyon.unicancer.fr

David KRYZA, Pharm.D

CONTACT

+33469856006david.kryza@univ-lyon1.fr

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

March 28, 2019

First Posted

April 4, 2019

Study Start

January 16, 2019

Primary Completion

August 16, 2021

Study Completion

August 16, 2021

Last Updated

October 14, 2020

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

FR(2)