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AzTrials

GlioblastomaNCT02379572

Impact of iMRI on the Extent of Resection in Patients With Newly Diagnosed Glioblastomas

A study testing iMRI-guided surgery and 5-ALA-guided surgery in people with Glioblastoma, run by University Hospital Tuebingen at 15 sites in Germany.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

Standard treatment of glioblastomas (GBMs) consists of microsurgical resection followed by concomitant chemoradiation. The extent of resection is one of the most important prognostic factors with significant influence on the survival of patients. Read more about this study

Who is it for?
Ages 18 to 80 years
Conditions the study is for
Glioblastoma
What is being tested?
iMRI-guided surgery and 5-ALA-guided surgery
Type of treatment
Medical device
Could I receive a placebo?
No, everyone receives an active treatment
How many people
315 participants
Where
15 sitesGermany
Study dates
Jun 2015to 1 Jul 2021
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 80 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • In MRI suspected primary singular untreated GBM
  • Planned total resection of the tumor according to the surgeon
  • Patient ≥18 years, ≤80 years
  • Preoperative KPS ≥ 60%, American Society of Anesthesiologists (ASA) score 1 and 2
  • Patients' informed consent

Who cannot join

  • Tumors of the midline, basal ganglia, cerebellum, brain stem, eloquent areas
  • Multifocal glioblastoma
  • Substantial (>50%), non-contrast enhancing tumor areas suggesting low-grade glioma with malignant transformation
  • Contraindications to MRI
  • Inability to give consent because of language barrier or dysphasia
  • Histological diagnosis other than Glioblastoma multiforme WHO °IV
Show all 13Show fewer
  • Increased risk of thrombosis (e.g. Factor V Leiden)
  • Pregnancy or breast feeding
  • Hypersensibility for 5-ALA oder porphyrins
  • Acute or chronic Porphyria
  • Renal insufficiency
  • Hepatic insufficiency
  • High likelihood of inability to receive adjuvant therapy

Trial locations and contacts

15 sites in 1 country.

15 sites in 1 country

Germany15 sites

  • Department of Neurosurgery, Universitätsklinikum Bonn, Bonn, Germany

    Bonn

  • Department of Neurosurgery, Universität zu Köln, Köln, Germany

    Cologne

  • Städtisches Klinikum Dresden Friedrichstadt

    Dresden

  • Department of Neurosurgery, Heinrich-Heine-Universität Düsseldorf, Düsseldorf

    Düsseldorf

  • Department of Neurosurgery, Friedrich-Alexander-University Erlangen-Nürnberg

    Erlangen

  • Department of Neurosurgery, Johann Wolfgang Goethe-University Frankfurt am Main

    Frankfurt a.M.

  • Department of Neurosurgery, Georg-August-Universität Göttingen, Göttingen,

    Göttingen

  • Department of Neurosurgery, University of Ulm, Hospital Günzburg,

    Günzburg

  • Asklepios Klinik Hamburg, Klinik für Neurochirurgie

    Hamburg

  • International Neuroscience Institute Hannover, Hannover, Germany

    Hanover

  • Department of Neurosurgery, Ruprecht-Karls-University Heidelberg

    Heidelberg

  • Department of Neurosurgery, University of Schleswig-Holstein, Kiel, Germany

    Kiel

  • Department of Neurosurgery, Westfälische Wilhelms-Universität Münster, Münster, Germany

    Münster

  • Department of Neurosurgery, Eberhard Karls University, Tübingen,

    Tübingen

  • Department of Neurosurgery, Julius-Maximilians-Universität Würzburg

    Würzburg

Other trials in Germany

About this study

Official title: Impact of iMRI on the Extent of Resection in Patients With Newly Diagnosed Glioblastomas - A Prospective Multicenter Parallel Group Clinical Trial

Standard treatment of glioblastomas (GBMs) consists of microsurgical resection followed by concomitant chemoradiation. The extent of resection is one of the most important prognostic factors with significant influence on the survival of patients. State of the art technique to achieve the most radical resection possible in conventional surgery is fluorescence-guidance with 5-aminolevulinic acid (5-ALA). If available, intraoperative MRI (iMRI)-guided tumor resection enables an intraoperative resection control and subsequent continuation of surgery if contrast enhancing tumor remnants are found. Therefore a more radical resection and longer survival of patients might be possible. To date no comparison of these two leading technologies for GBM-surgery is available to identify the best surgical therapy of this fatal disease and to justify significant healthcare-economic differences between both technologies.

Goal of this study is to assess the value of iMRI guidance in the resection of GBMs in comparison to conventional 5-ALA microsurgery. Primary endpoint is the number of total resections (no residual contrast enhancement) in the postoperative MRI (T1+CM within 48 hours after surgery) in each group. Secondary endpoints are perioperative clinical data, progression free survival, patients' clinical condition and overall survival.

The study design was chosen to be a parallel-group approach to compare iMRI and 5-ALA centers (n=13) to exclude possible bias which might be found by randomizing patients within individual iMRI centers and to have surgeons with the most experience possible in use of each respective technology.

Conditions
Glioblastoma
Being tested
iMRI-guided surgery, 5-ALA-guided surgery
Keywords
5-ALA, Intraoperative MRI, Extent of resection
Medical subject headings
Glioblastoma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • iMRI-guided surgeryDevice

    For iMRI-guided glioma resections the surgery can be paused and a direct intraoperative resection control is possible by performing an intraoperative MRI scan. If residual tumor is found, the resection might be continued.

  • 5-ALA-guided surgeryDrug

    For 5-ALA guided glioma resections patients have to drink 100ml of a solution with 5-Aminolevulinic acid 4-6 hours before surgery. Intraoperatively the light source of the surgical microscope can be switched to a certain wave length to enable fluorescence of the glioma cells, which helps resecting the tumor as radical as possible.

Study groups in NCT02379572
Study groupRoleWhat they receive
iMRI-guided surgeryExperimentalResection of Glioblastomas with iMRI-guidance
Receives: Device: iMRI-guided surgery
5-ALA-guided surgeryActive comparatorResection of Glioblastomas with 5-ALA-fluorescence-guidance
Receives: Drug: 5-ALA-guided surgery

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Complete resections in the postoperative MRI (T1+/-CM) within 48 hours after surgery

    Completeness of resection in the postoperative MRI within 48h after surgery. Blinded analysis by an independent radiologist.

    Measured: 48 hour

Secondary outcomes (12)

  1. Patients' clinical condition (KPS)

    -KPS clinical scoring

    Measured: preoperative (day before surgery), 1 week, 3Months, 6Months, 9Months, 12Months after surgery

  2. Patients' clinical condition (NIHSS)

    -NIHSS stroke score

    Measured: preoperative (day before surgery), 1 week, 3Months, 6Months, 9Months, 12Months after surgery

  3. Patients' clinical condition (QoL)

    -quality of life (EORTC) questionnaire

    Measured: preoperative (day before surgery), 1 week, 3Months, 6Months, 9Months, 12Months after surgery

  4. ICU and hospital stay after surgery

    -ICU and overall hospital stay after surgery

    Measured: Time of hospital stay (average 7days)

  5. Patients' adjuvant treatment

    -adjuvant treatment each patient has received

    Measured: 3Months, 6Months, 9Months, 12Months after surgery

  6. Recurrent tumor growth (RANO criteria)

    -recurrent tumor growth (RANO criteria) according to local tumor boards and independent blinded analysis

    Measured: 3Months, 6Months, 9Months, 12Months after surgery

  7. Follow-up imaging

    -follow-up imaging 3, 6, 9, 12 months postoperative incl. independent blinded analysis

    Measured: 3Months, 6Months, 9Months, 12Months after surgery

  8. Histology

    Histological analysis

    Measured: 1 week after surgery

  9. MGMT (O6-methylguanine-DNA-methyltransferase) analysis

    MGMT promoter analysis (Routine molecular diagnostics)

    Measured: 1 week after surgery

  10. IDH-1 (isocitrate dehydrogenase) analysis

    IDH-1 mutation analysis (Routine molecular diagnostics)

    Measured: 1 week after surgery

  11. Progression-free survival (PFS)

    6M\&12M-PFS

    Measured: Day of surgery - 6 months - 12 months

  12. Overall survival (OS)

    OS of patients

    Measured: Day of surgery - Death of patient (Max. 10 years follow-up)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Mar 2015 (estimated)
  2. Study startJun 2015
  3. Primary completionJun 2020
  4. Study completion1 Jul 2021

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Non-randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
315 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02379572
Sponsor's protocol ID
Nch1
Status last verified
Jul 2020
First submitted
18 Feb 2015
Last updated
22 Oct 2021
Results posted
No
Data monitoring committee
Yes

Publications

  • Roder C, Stummer W, Coburger J, Scherer M, Haas P, von der Brelie C, Kamp MA, Lohr M, Hamisch CA, Skardelly M, Scholz T, Schipmann S, Rathert J, Brand CM, Pala A, Ernemann U, Stockhammer F, Gerlach R, Kremer P, Goldbrunner R, Ernestus RI, Sabel M, Rohde V, Tabatabai G, Martus P, Bisdas S, Ganslandt O, Unterberg A, Wirtz CR, Tatagiba M. Intraoperative MRI-Guided Resection Is Not Superior to 5-Aminolevulinic Acid Guidance in Newly Diagnosed Glioblastoma: A Prospective Controlled Multicenter Clinical Trial. J Clin Oncol. 2023 Dec 20;41(36):5512-5523. doi: 10.1200/JCO.22.01862. Epub 2023 Jun 19.

    PubMed 37335962

Questions about this trial

What is this clinical trial studying?

A study testing iMRI-guided surgery and 5-ALA-guided surgery in people with Glioblastoma, run by University Hospital Tuebingen at 15 sites in Germany.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 22 Oct 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 15 sites in Germany. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Complete resections in the postoperative MRI (T1+/-CM) within 48 hours after surgery (time frame: 48 hour). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02379572, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Oct 2021.

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