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

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ClinicalTrials.gov Identifier: NCT02379572
Recruitment Status : Completed
First Posted : March 5, 2015
Last Update Posted : October 22, 2021
Information provided by (Responsible Party):
University Hospital Tuebingen

Tracking Information
First Submitted Date  ICMJE February 18, 2015
First Posted Date  ICMJE March 5, 2015
Last Update Posted Date October 22, 2021
Study Start Date  ICMJE June 2015
Actual Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 26, 2015)
Complete resections in the postoperative MRI (T1+/-CM) within 48 hours after surgery [ Time Frame: 48 hour ]
Completeness of resection in the postoperative MRI within 48h after surgery. Blinded analysis by an independent radiologist.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE
 (submitted: February 26, 2015)
  • Patients' clinical condition (KPS) [ Time Frame: preoperative (day before surgery), 1 week, 3Months, 6Months, 9Months, 12Months after surgery ]
    -KPS clinical scoring
  • Patients' clinical condition (NIHSS) [ Time Frame: preoperative (day before surgery), 1 week, 3Months, 6Months, 9Months, 12Months after surgery ]
    -NIHSS stroke score
  • Patients' clinical condition (QoL) [ Time Frame: preoperative (day before surgery), 1 week, 3Months, 6Months, 9Months, 12Months after surgery ]
    -quality of life (EORTC) questionnaire
  • ICU and hospital stay after surgery [ Time Frame: Time of hospital stay (average 7days) ]
    -ICU and overall hospital stay after surgery
  • Patients' adjuvant treatment [ Time Frame: 3Months, 6Months, 9Months, 12Months after surgery ]
    -adjuvant treatment each patient has received
  • Recurrent tumor growth (RANO criteria) [ Time Frame: 3Months, 6Months, 9Months, 12Months after surgery ]
    -recurrent tumor growth (RANO criteria) according to local tumor boards and independent blinded analysis
  • Follow-up imaging [ Time Frame: 3Months, 6Months, 9Months, 12Months after surgery ]
    -follow-up imaging 3, 6, 9, 12 months postoperative incl. independent blinded analysis
  • Histology [ Time Frame: 1 week after surgery ]
    Histological analysis
  • MGMT (O6-methylguanine-DNA-methyltransferase) analysis [ Time Frame: 1 week after surgery ]
    MGMT promoter analysis (Routine molecular diagnostics)
  • IDH-1 (isocitrate dehydrogenase) analysis [ Time Frame: 1 week after surgery ]
    IDH-1 mutation analysis (Routine molecular diagnostics)
  • Progression-free survival (PFS) [ Time Frame: Day of surgery - 6 months - 12 months ]
  • Overall survival (OS) [ Time Frame: Day of surgery - Death of patient (Max. 10 years follow-up) ]
    OS of patients
Original Secondary Outcome Measures  ICMJE Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 26, 2015)
Preoperative tumor localization and resectability concerning eloquent regions [ Time Frame: Blinded analysis of preoperative imaging (not older than 3 days prior to surgery) ]
Independent blinded analysis of the preoperative imaging data by a blinded neurosurgeon with extensive experience in the resection of gliomas. Analysis will be done before the final evaluation of results. (Within 12 months)
Original Other Pre-specified Outcome Measures Same as current
Descriptive Information
Brief Title  ICMJE Impact of iMRI on the Extent of Resection in Patients With Newly Diagnosed Glioblastomas
Official Title  ICMJE Impact of iMRI on the Extent of Resection in Patients With Newly Diagnosed Glioblastomas - A Prospective Multicenter Parallel Group Clinical Trial
Brief 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. 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.

Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Single (Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Glioblastoma
Intervention  ICMJE
  • Device: iMRI-guided surgery
    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.
  • Drug: 5-ALA-guided surgery
    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 Arms  ICMJE
  • Experimental: iMRI-guided surgery
    Resection of Glioblastomas with iMRI-guidance
    Intervention: Device: iMRI-guided surgery
  • Active Comparator: 5-ALA-guided surgery
    Resection of Glioblastomas with 5-ALA-fluorescence-guidance
    Intervention: Drug: 5-ALA-guided surgery
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: July 10, 2020)
Original Estimated Enrollment  ICMJE
 (submitted: February 26, 2015)
Actual Study Completion Date  ICMJE July 1, 2021
Actual Primary Completion Date June 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

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

Exclusion Criteria:

  1. Tumors of the midline, basal ganglia, cerebellum, brain stem, eloquent areas
  2. Multifocal glioblastoma
  3. Substantial (>50%), non-contrast enhancing tumor areas suggesting low-grade glioma with malignant transformation
  4. Contraindications to MRI
  5. Inability to give consent because of language barrier or dysphasia
  6. Histological diagnosis other than Glioblastoma multiforme WHO °IV
  7. Increased risk of thrombosis (e.g. Factor V Leiden)
  8. Pregnancy or breast feeding
  9. Hypersensibility for 5-ALA oder porphyrins
  10. Acute or chronic Porphyria
  11. Renal insufficiency
  12. Hepatic insufficiency
  13. High likelihood of inability to receive adjuvant therapy
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years to 80 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Germany
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT02379572
Other Study ID Numbers  ICMJE Nch1
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party University Hospital Tuebingen
Original Responsible Party Same as current
Current Study Sponsor  ICMJE University Hospital Tuebingen
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Principal Investigator: Constantin Roder, Dr. University Hospital Tuebingen, Department of Neurosurgery
PRS Account University Hospital Tuebingen
Verification Date July 2020

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP