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PET Imaging of High-grade Glioma Using 18F-fluoromethylcholine: a Tool for the Early Detection of Tumour Recurrence After Combined Radiochemotherapy?

Primary Purpose

High-grade Glioma of the Brain

Status
Completed
Phase
Phase 1
Locations
Belgium
Study Type
Interventional
Intervention
PET images with 18F-fluoromethylcholine
Sponsored by
University Ghent
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for High-grade Glioma of the Brain

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 18 years or older
  • patients with high-grade glioma who will undergo adjuvant radiochemotherapy after surgery

Exclusion Criteria:

  • low global performance state
  • pregnancy
  • lactation period
  • presence of pacemaker, vascular clips in the brain ,epidural electrodes, implanted hearing device, set of false theeth attached by means of magnetes, wig attached by means of metal clips

Sites / Locations

  • University Hospital Ghent

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

1

Arm Description

18F-fluoromethylcholine

Outcomes

Primary Outcome Measures

time to local recurrence after neurosurgery and adjuvant radiochemotherapy

Secondary Outcome Measures

Full Information

First Posted
February 26, 2008
Last Updated
May 15, 2018
Sponsor
University Ghent
Collaborators
Research Foundation Flanders, Special Research Fund, Belgium
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1. Study Identification

Unique Protocol Identification Number
NCT00628940
Brief Title
PET Imaging of High-grade Glioma Using 18F-fluoromethylcholine: a Tool for the Early Detection of Tumour Recurrence After Combined Radiochemotherapy?
Official Title
PET Imaging of High-grade Glioma Using 18F-fluoromethylcholine: a Tool for the Early Detection of Tumour Recurrence After Combined Radiochemotherapy?
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Completed
Study Start Date
January 12, 2010 (Actual)
Primary Completion Date
March 14, 2017 (Actual)
Study Completion Date
March 22, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Ghent
Collaborators
Research Foundation Flanders, Special Research Fund, Belgium

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
The aim of the study is to define preferential sites of tumour recurrence by observing tracer uptake in the tumour in sequential PET images with 18F-fluoromethylcholine (and perfusion MR, see also below). Changes in the intensity of the tracer uptake in the tumour during and after the course of radiotherapy will be correlated with the site of tumour recurrence as will be assessed by conventional MRI. In due time, these results must enable clinicians to change their therapeutic approach of high-grade glioma.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
High-grade Glioma of the Brain

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Phase 1
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
90 (Actual)

8. Arms, Groups, and Interventions

Arm Title
1
Arm Type
Experimental
Arm Description
18F-fluoromethylcholine
Intervention Type
Radiation
Intervention Name(s)
PET images with 18F-fluoromethylcholine
Intervention Description
sequential PET images with 18F-fluoromethylcholine
Primary Outcome Measure Information:
Title
time to local recurrence after neurosurgery and adjuvant radiochemotherapy
Time Frame
18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 18 years or older patients with high-grade glioma who will undergo adjuvant radiochemotherapy after surgery Exclusion Criteria: low global performance state pregnancy lactation period presence of pacemaker, vascular clips in the brain ,epidural electrodes, implanted hearing device, set of false theeth attached by means of magnetes, wig attached by means of metal clips
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Ingeborg Goethals, MD, PhD
Organizational Affiliation
University Hospital, Ghent
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital Ghent
City
Ghent
ZIP/Postal Code
9000
Country
Belgium

12. IPD Sharing Statement

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PET Imaging of High-grade Glioma Using 18F-fluoromethylcholine: a Tool for the Early Detection of Tumour Recurrence After Combined Radiochemotherapy?

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