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Positron Emission Tomography-Computed Tomography (PET-CT) High-Grade Glioma
This study has been terminated.
( Patient compliance was low. )
First Received: March 20, 2008   Last Updated: October 24, 2008   History of Changes
Sponsors and Collaborators: Maastricht Radiation Oncology
Maastricht University Medical Center
Information provided by: Maastricht Radiation Oncology
ClinicalTrials.gov Identifier: NCT00643591
  Purpose

The objectives of the trial are:

  • To determine the localisation within the primary tumor of the therapy resistant cells, before and during radiotherapy to determine a possible accurate boost volume.
  • To determine changes during treatment intra- and extratumoral within the irradiated area.(Intratumoral: change of up-take - decrease, increase, change of localization/ Extratumoral: effects of temporal changes in up-take - e.g. due to oedema).

Condition Intervention
Cerebral Astrocytoma, High Grade
Other: imaging (dynamic PET-CT scan)

MedlinePlus related topics: CT Scans Cancer Nuclear Scans Radiation Therapy
U.S. FDA Resources
Study Type: Observational
Study Design: Case-Only, Prospective
Official Title: Pilot Study on the Determination of Therapy Resistant Areas Within the Tumor in Patients With High-Grade Glioma by Repeated 18F-FDG-PET-CT Scans

Further study details as provided by Maastricht Radiation Oncology:

Primary Outcome Measures:
  • To determine the localisation within the primary tumour of the therapy resistant cells, before and during radiotherapy to determine the accurate boost volume. To determine changes during treatment intra- and extratumoral within the irradiated area. [ Time Frame: after acquisition of all planned PET CTs ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples Without DNA

Biospecimen Description:

EDTA blood, serum


Estimated Enrollment: 10
Study Start Date: June 2008
Estimated Study Completion Date: June 2010
Estimated Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
Observational
Patients with a primary glioblastoma
Other: imaging (dynamic PET-CT scan)
dynamic PET-CT scan

Detailed Description:

Patients harboring a primary intracerebral high grade tumor (WHO III- IV) have a median survival of six to 12 months. Combined chemoradiotherapy with temozolomide is now the standard of care since results of the joint EORTC-NCIC phase III study randomizing between radiotherapy alone and combined radiochemotherapy with temozolomide showed a significant improvement in 2-years survival from 8% to 24% for the combined treatment arm (Stupp 2005).

A differentiation between possible responders and non-responders before the start of irradiation may eventual be possible by the use of 18F-FDG PET-CT.

Preliminary own results have shown that a higher metabolic activity in glioblastoma as measured on a simulation 18F-FDG PET-CT scan can be a prognosticator for shortened survival (Baumert, 2006). Our preliminary data show that a high uptake of 18F-FDG on a PET-CT scan before radiotherapy in glioblastoma could be a marker for reduced survival. Popperl et al showed that dual phase FDG PET imaging is superior in differentiating low-grade from high-grade recurrent astrocytomas (Popperl, 2006).

Visual analysis of delineation of glioma showed that the delayed images (imaged first 0-90 min and once or twice later at 180-480 min after injection) better distinguished the high uptake in tumors relative to uptake in gray matter. SUV comparisons also showed greater uptake in the tumors than in gray matter, brain, or white matter at the delayed times (Spence et al). These findings support the view that by using FDG-PET scans we could image active areas within the tumor. Indeed, in vivo, a cancer is made up by different types of cells, including hypoxic cells, cells that proliferate more fast, as well as by non-malignant tissues, including inflammatory cells and vasculature. Intra-tumor heterogeneity in malignant glioma is often observed and can be visualised also by current PET-CT techniques.

The dynamics of the tracer uptake in the different tumor sub-volumes may give important information about the biological characteristics as well. Indeed, the dynamics of FDG uptake per cell are dependent on the blood flow, the uptake in the cell and the phosphorylation. All these of these steps give information on the biology of the cancer in that particular area of the tumor.

  Eligibility

Ages Eligible for Study:   19 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population

Patients treated with radical radiotherapy for a high grade glioma.

Criteria

Inclusion Criteria:

  • Histologically confirmed gliomas III - IV (glioblastoma, anaplastic astrocytoma, gliosarcoma) at primary diagnosis;
  • WhO PFS <= 2
  • Tumours which do enhance on pre-operative imaging.
  • Post-operative enough visible residual tumour on PET or status after biopsy only
  • Age >18 years
  • Availability of deep fresh frozen tissue for molecular biologic evaluation - if possible
  • Patient able to tolerate full course of conventional RT and follow serial scanning
  • No previous radiotherapy to the head and neck and brain area.
  • Prior neurosurgery within 6 weeks of treatment
  • No previous chemotherapy before treatment of the glioma. Standard radiochemotherapy with temozolomide is not excluded
  • No prior or concurrent medical condition which would make treatment difficult to complete. Medication with steroids is allowed.
  • No incapacitated patients.

Exclusion Criteria:

  • Not histologically confirmed gliomas III - IV (glioblastoma, anaplastic astrocytoma, gliosarcoma) at primary diagnosis;
  • WhO PFS > 2
  • No tumours which do enhance on pre-operative imaging.
  • Post-operative not enough visible residual tumor on PET or status after biopsy only
  • Age <18 years
  • No availability of deep fresh frozen tissue for molecular biologic evaluation
  • Patient not able to tolerate full course of conventional RT and follow serial scanning
  • Previous radiotherapy to the head and neck and brain area.
  • Prior neurosurgery not within 6 weeks of treatment
  • Previous chemotherapy before treatment of the glioma.
  • Prior or concurrent medical condition which would make treatment difficult to complete.
  • Incapacitated patients.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00643591

Locations
Netherlands
Maastricht Radiation Oncology
Maastricht, Netherlands, 6202 AZ
Sponsors and Collaborators
Maastricht Radiation Oncology
Maastricht University Medical Center
Investigators
Principal Investigator: Brigitta Baumert, MD PhD Maastricht Radiation Oncology
  More Information

No publications provided

Responsible Party: Maastricht Radiation Oncology ( Philippe Lambin, Prof. PhD. )
Study ID Numbers: MAASTRO 07-12-12/09, EudraCT Number 2007-005530-36
Study First Received: March 20, 2008
Last Updated: October 24, 2008
ClinicalTrials.gov Identifier: NCT00643591     History of Changes
Health Authority: Netherlands: The Central Committee on Research Involving Human Subjects (CCMO)

Keywords provided by Maastricht Radiation Oncology:
high grade glioma
FDG-PET-CT
blood proteins
prognosis

Study placed in the following topic categories:
Neuroectodermal Tumors
Astrocytoma
Neoplasms, Germ Cell and Embryonal
Neuroepithelioma
Glioma
Neoplasms, Glandular and Epithelial

Additional relevant MeSH terms:
Neuroectodermal Tumors
Neoplasms
Neoplasms by Histologic Type
Astrocytoma
Neoplasms, Germ Cell and Embryonal
Neoplasms, Nerve Tissue
Glioma
Neoplasms, Neuroepithelial
Neoplasms, Glandular and Epithelial

ClinicalTrials.gov processed this record on May 07, 2009