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

NCT01873469 | Completed

• 1 other identifier: STR-PETra-2013
• Study Type: observational
• Target: 102
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Glioblastoma Multiforme

Keywords

glioblastoma multiforme; radiotherapy

Outcome Measures

Primary Outcomes (1)

• Time to recurrence as function of [11C]MET uptake before postoperative radiochemotherapy

  participants will be followed until tumour recurrence, an expected average of 7 months

Secondary Outcomes (1)

• overall survival

  expected average 15 months

Study Arms (1)

Radiochemotherapy

glioblastoma patients with indication to radiochemotherapy

Radiation: Radiochemotherapy

Interventions

Radiochemotherapy RADIATION

postoperative radiochemotherapy 60 Gy/ Temozolomide

Radiochemotherapy

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with the diagnosis of glioblastoma multiforme

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Technische Universität Dresden: lead

Study Sites (1)

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

Dresden, Saxony, 01307, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

fresh tumour pieces, blood samples

MeSH Terms

Conditions

Glioblastoma

Interventions

Chemoradiotherapy

Condition Hierarchy (Ancestors)

Astrocytoma; Glioma; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Drug Therapy; Radiotherapy

Study Officials

• Mechthild Krause, MD

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

  STUDY CHAIR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PD Dr. med.

Study Record Dates

• First Submitted: June 4, 2013
• First Posted: June 10, 2013
• Study Start: July 1, 2013
• Primary Completion: October 1, 2017
• Study Completion: October 1, 2018
• Last Updated: February 18, 2019

Record last verified: 2019-02

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)