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Amino-acid PET Versus MRI Guided Re-irradiation in Patients With Recurrent Glioblastoma Multiforme

Study Purpose

This study is designed to evaluate the impact of radiotherapy target volume delineation based on AA-PET compared to target volume delineation based on contrast enhanced T1 weighted MRI (T1Gd-MRI) on the clinical outcome of patients with recurrent glioblastoma (GBM) as well as concerning therapeutic safety of the respective strategy.

Recruitment Criteria

Accepts Healthy Volunteers

Healthy volunteers are participants who do not have a disease or condition, or related conditions or symptoms

 No
Study Type

An interventional clinical study is where participants are assigned to receive one or more interventions (or no intervention) so that researchers can evaluate the effects of the interventions on biomedical or health-related outcomes.


An observational clinical study is where participants identified as belonging to study groups are assessed for biomedical or health outcomes.


Searching Both is inclusive of interventional and observational studies.

 Interventional
Eligible Ages 18 Years and Over
Gender All
More Inclusion & Exclusion Criteria

Inclusion Criteria:

  • - Local recurrence of GBM (WHO grade IV) and either not eligible for tumor resection or with macroscopic residual tumor after resection of recurrent GBM.
  • - Recurrent tumor visible on AA-PET and MRI-T1-Gd with the diameter measuring 1 cm to 6 cm by either technique.
  • - Target volume definition possible according to both study arms.
  • - Previous radiation therapy of the primary with a maximal total dose 60 Gy.
  • - At least 9 months since the end of pre-irradiation and randomisation.
  • - At most 2 prior chemotherapy regimes.
  • - Start of radiation therapy possible within 2 weeks from AA-PET.
  • - Karnofsky Performance Score (KPS) ≥ 70% - Age ≥ 18 years.
  • - Written informed consent (IC) obtained.

Exclusion Criteria:

  • - - No histological confirmation of Glioma at initial diagnosis) - Recent (≤ 4 weeks before IC) histological result showing no tumor recurrence.
  • - No recurrent tumor detectable on last AA-PET or MRI-T1-Gd.
  • - Technical impossibility to use existing AA-PET for RT-planning.
  • - No prior radiation treatment to the primary tumor.
  • - less than 9 months between the end of first radiation treatment and randomisation.
  • - more than 2 previous chemotherapy regimes or previous treatment with Avastin or other molecular targeted therapies.
  • - less than 2 weeks between application of chemotherapy and randomisation.
  • - additional chemotherapy or molecular targeted therapy or further surgery planned before diagnosis of further tumor progression after study intervention.
- pregnancy, nursing or patient not willing to prevent pregnancy during treatment

Trial Details

Trial ID:

This trial id was obtained from ClinicalTrials.gov, a service of the U.S. National Institutes of Health, providing information on publicly and privately supported clinical studies of human participants with locations in all 50 States and in 196 countries.

 NCT01252459
Phase

Phase 1: Studies that emphasize safety and how the drug is metabolized and excreted in humans.

Phase 2: Studies that gather preliminary data on effectiveness (whether the drug works in people who have a certain disease or condition) and additional safety data.

Phase 3: Studies that gather more information about safety and effectiveness by studying different populations and different dosages and by using the drug in combination with other drugs.

Phase 4: Studies occurring after FDA has approved a drug for marketing, efficacy, or optimal use.

 Phase 2
Lead Sponsor

The sponsor is the organization or person who oversees the clinical study and is responsible for analyzing the study data.

 University Hospital Freiburg
Principal Investigator

The person who is responsible for the scientific and technical direction of the entire clinical study.

 Anca-Ligia Grosu, Prof. Dr. med.Wolfgang Weber, Prof. Dr. med.Ursula Nestle, PD Dr. med.
Principal Investigator Affiliation Department of Radiotherapy, University Hospital FreiburgDepartment of Nuclear Medicine, University Hospital FreiburgDepartment of Radiotherapy, University Hospital Freiburg
Agency Class

Category of organization(s) involved as sponsor (and collaborator) supporting the trial.

 Other
Overall Status Unknown status
Countries Germany
Conditions

The disease, disorder, syndrome, illness, or injury that is being studied.

 Recurrent Glioma (Glioblastoma Multiforme)
Additional Details

The higher sensitivity and specificity of amino-acids (L-[methyl-11C]-methionine, MET and O-(2-(1)-Fluoroethyl)-L-tyrosine, FET) positron emission tomography (AA-PET) in the diagnosis of gliomas in comparison to computed tomography (CT) and magnetic resonance imaging (MRI) was demonstrated in many studies and is the rationale for using them in target volume delineation of these tumors. Several clinical trials have demonstrated the significant differences between AA-PET and standard MRI in gross tumor volume (GTV) delineation for treatment planning. A small prospective study in patients with recurrent high grade gliomas treated with stereotactic fractionated radiotherapy (SFRT) showed a significant improvement in survival when AA-PET or single photon emission tomography (AA-SPECT) were integrated in target volume delineation, in comparison to patients treated using CT/MRI alone (Grosu et al. 2005). However, there are no randomized studies demonstrating the impact of AA-PET based irradiation treatment on the clinical follow-up in comparison to a traditional MRI/CT based treatment. The goal of this study is to evaluate the impact of radiotherapy target volume delineation based on AA-PET (new strategy) on the clinical outcome of patients with recurrent glioblastoma (GBM) compared to target volume delineation based on contrast enhanced T1 weighted MRI (T1Gd-MRI) (traditional, established strategy). Concerning therapeutic safety, the topography of recurrence outside the primary target volume as well as the localization of necrosis after the re-irradiation will be determined. All side effects will be assessed by CTCAE version 4.0 and the safety analyses will present the worst grade of acute and late side effect by treatment arm for the whole study period (treatment and follow up). Patients will be asked to complete a quality of life (QoL) questionnaire (as assessed by the E-ORTC QLQ-C15 PAL) in regular time intervals. This will be the first phase II randomized study evaluating the impact of molecular imaging on outcome after radiotherapy in brain tumor patients. Another goal of the technical part of this study is the development of a standardized physical-technical methodology for the integration of AA-PET and other imaging biomarkers in tumor volume delineation in radiation therapy.

Arms & Interventions

Arms

Experimental: Arm A: AA-PET based target volume delineation

Experimental intervention (Arm A): High-precision re-irradiation. Target volume delineation based on AA-PET.

Active Comparator: Arm B: T1Gd-MRI based target volume delineation

Control intervention (Arm B): High-precision re-irradiation. Target volume delineation based on T1Gd-MRI.

Interventions

Radiation: - Radiation Therapy

Experimental intervention (Arm A): High-precision re-irradiation (stereotactic fractionated radiation therapy (SFRT) and/or image guided radiation therapy, (IGRT), total dose 39 Gy, 3 Gy/d, 5x/ week. Target volume delineation based on AA-PET: GTV = AA uptake on PET, clinical target volume (CTV) = GTV+3mm, PTV = CTV+2mm

Radiation: - Radiation Therapy

Control intervention (Arm B): High-precision re-irradiation (SFRT and/or IGRT), total dose 39 Gy, 3 Gy/d, 5x/ week. Target volume delineation based on T1Gd-MRI: GTV = contrast enhancement on T1Gd-MRI, CTV = GTV+3mm, PTV = CTV+2mm

Contact a Trial Team

If you are interested in learning more about this trial, find the trial site nearest to your location and contact the site coordinator via email or phone. We also strongly recommend that you consult with your healthcare provider about the trials that may interest you and refer to our terms of service below.

International Sites

Freiburg i. Br., Baden-Wuerttemberg, Germany

Status

Address

Department of Radiotherapy, University Hospital Freiburg

Freiburg i. Br., Baden-Wuerttemberg, 79106

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