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Impact of [11C]-Methionine PET/MRI for Individual Tailoring Postoperative Radiochemotherapy for Glioblastoma Multiforme

Study Purpose

Local recurrence is a major problem of clinical treatment of glioblastoma multiforme (GBM). Today a very sensitive imaging method to detect glioblastoma is [11C]MET Positron emission tomography (PET), where in some patients also tumour manifestations can be detected that are not visible in MRI investigations. The aim of the study is to investigate the association of high [11C]MET tracer uptake before postoperative radiochemotherapy and concurrent temozolomide (TMZ) with time to recurrence in patients with glioblastoma multiforme. Also site of recurrence will be correlated with the [11C]MET imaging before and early during radiochemotherapy. All imaging information will be included in treatment planning or treatment decisions. The study provides a basis for later radiation dose escalation trials on the base of [11C]MET imaging.

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.

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

Inclusion Criteria:

  • - histologically confirmed newly diagnosed glioblastoma multiforme.
  • - macroscopic total tumour resection or biopsy.
  • - indication for combined radiochemotherapy with temozolomide.
  • - patients are allowed to take part in other clinical trials at the same time.
  • - beginning of radiochemotherapy no later than 7 weeks after surgery.
  • - Karnofsky Performance Score ≥ 60, ECOG ≤2.
  • - women with childbearing potential, (and men) adequate contraception.
  • - ability of subject to understand character and individual consequences of the clinical trial.
  • - written informed consent.

Exclusion Criteria:

  • - previous radiotherapy of the brain or chemotherapy with TMZ other than during the radiochemotherapy.
  • - time interval of > 7 weeks after surgery and beginning of radiochemotherapy.
  • - patients who are not suitable for radiochemotherapy.
  • - known other malignant disease that impacts prognosis of the patient and/or is likely to require treatment interfering with study therapy.
  • - pregnant or lactating women.
  • - patients with non-MRI compatible metal implants, pacemaker or non-MRI compatible external automatic defibrillators, insulin pumps, neurostimulators, cochlear implants.
  • - Claustrophobic patients.
- refusal of the patients to take part in the study

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.

 NCT01873469
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.
Lead Sponsor

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

 Technische Universität Dresden
Principal Investigator

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

 Mechthild Krause, MD
Principal Investigator Affiliation Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Therapy and Radiation Oncology; and DKTK partner site Dresden
Agency Class

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

 Other
Overall Status Completed
Countries Germany
Conditions

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

 Glioblastoma Multiforme
Additional Details

The current study aims to investigate the association of high [11C]MET tracer uptake before postoperative radiochemotherapy and concurrent temozolomide (TMZ) with time to recurrence in patients with glioblastoma multiforme (GBM). [11C]MET-PET is expected to provide diagnostic (quantitative and spatial information) as well as prognostic information, to monitor treatment, to help stratification of patients for radiotherapeutic interventions such as dose-painting in order to optimize clinical applications and potentially improve the treatment outcome. This study aims to provide the basis (e.g. optimal threshold value, sensitivity, specificity of MET uptake) for later intervention trials for treatment intensification, e.g. proton boost irradiation based on specific biomarkers. The trial is a one-arm single-center, non-randomized observational (biomarker) study. After resection or biopsy, patients with newly diagnosed glioblastoma multiforme will receive a [11C]MET-PET/MRI scan before start of concurrent radiochemotherapy (~1-4 weeks after surgery). A fusion with the planning CT for irradiation treatment planning will be performed. Postoperative radiotherapy will be applied in daily fractions of 2 Gy given 5 days per week for 6 weeks, for a total dose of 60 Gy (50 Gy and a boost of 10 Gy), with concomitant administration of daily Temozolomide (75 mg/m2 p.o.) from the 1st day to the last day of radiotherapy. Follow up with [11C]MET-PET/MRI will be performed every 3 months until recurrence or until death of the patient. The uptake of [11C]MET-PET (as standard uptake value

  • - SUV) in tumour and in normal contralateral grey matter before start of concurrent radiochemotherapy will be determined.
For each tumour, the ratio between tracer uptake in the tumor and contralateral gray matter will be calculated (lesion-to-gray matter ratio [l/g]). Primary end point will be time to recurrence (TTR) as function of [11C]MET uptake before chemoradiotherapy. Secondary endpoints will be overall survival; toxicity; C-Index/ROC curve (sensitivity, specificity, optimal threshold for normal/tumour tissue index), necrosis rate; site of recurrence. The primary analysis will use the Cox proportional hazard model to establish the linear association between [11C]-MET and time-to-recurrence using a one-sided alpha = 0.1. Parallel translational studies with orthotopic GBM xenografts (generated from the patients material in the trial) in nude mice will be performed in our laboratory to evaluate [11C]MET-PET as a tool for tailoring high precision radiotherapy. Histological, biological and genetic studies are planned to validate the imaging finding and to explore the underlying mechanisms.

Arms & Interventions

Arms

: Radiochemotherapy

glioblastoma patients with indication to radiochemotherapy

Interventions

Radiation: - Radiochemotherapy

postoperative radiochemotherapy 60 Gy/ Temozolomide

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

Dresden, Saxony, Germany

Status

Address

Dresden University of Technology, University Hospital Carl Gustav Carus, Department of Radiation Oncology; and DKTK partner site Dresden

Dresden, Saxony, 01307

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