NCT04588454

Brief Summary

This is a pilot study to determine uptake of PET tracer 18F-PSMA-1007 in primary glioblastoma.

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
5

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

Geographic Reach
1 country

1 active site

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 17, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

October 8, 2020

Completed
11 days until next milestone

First Posted

Study publicly available on registry

October 19, 2020

Completed
12 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2020

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2021

Completed
Last Updated

January 27, 2021

Status Verified

October 1, 2020

Enrollment Period

10 months

First QC Date

October 8, 2020

Last Update Submit

January 26, 2021

Conditions

Glioblastoma Multiforme

Keywords

nuclear imagingprostate specific membrane antigenglioblastoma multiformepositron emission tomography

Outcome Measures

Primary Outcomes (1)

  • The uptake of 18F-PSMA PET/CT in suspected GBM lesions

    uptake of the tracer at 2 hours post injection

Secondary Outcomes (2)

  • The correlation between PSMA protein and RNA expression with 18F-PSMA PET/CT uptake

    uptake of the tracer at 2 hours post injection vs RNA expression determined from excised tumor tissue

  • Correlation between 18F-PSMA PET/CT and T1Gd MRI

    Uptake of the tracer at 2 hours post injection vs pre-op MRI

Study Arms (1)

18F-PSMA-1007 PET/CT

EXPERIMENTAL
Other: 18F-PSMA-1007 PET tracer

Interventions

18F-PSMA-1007 PET tracerOTHER

18F-PSMA-1007 PET/CT

18F-PSMA-1007 PET/CT

Eligibility Criteria

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

You may qualify if:

  • Suspected GBM on MRI scan
  • Scheduled for tumor resection at Radboudumc
  • Age ≥18 years

You may not qualify if:

  • Age \< 18 years
  • Pregnancy or the wish to become pregnant within 6 months
  • Creatinine clearance below 40ml/min
  • Liver disease defined as aspartate aminotransferase or alanine aminotransferase level of more than three times the upper limit of normal range

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Radboud University Medical Center

Nijmegen, Gelderland, 6525 GA, Netherlands

Location

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

Condition Hierarchy (Ancestors)

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

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

October 8, 2020

First Posted

October 19, 2020

Study Start

January 17, 2020

Primary Completion

October 31, 2020

Study Completion

June 1, 2021

Last Updated

January 27, 2021

Record last verified: 2020-10

Data Sharing

IPD Sharing
Will not share

Locations

NL(1)