Glioma Mesoscopic Imaging
Organizational Data
- DRKS-ID:
- DRKS00005580
- Recruitment Status:
- Recruiting stopped (after recruiting started)
- Date of registration in DRKS:
- 2014-06-18
- Last update in DRKS:
- 2019-01-02
- Registration type:
- Prospective
Acronym/abbreviation of the study
GlioMI
URL of the study
No Entry
Brief summary in lay language
Mesoscopic Imaging means that the microstructure of the brain can be investigated by Magnetic Resonance Imaging, although the resolution of the images is in the range of millimeters instead of micrometers. The MR investigation itself is prolonged for about 10 minutes and contains the routinely performed contrast application. This method is to be applied to human brain tumours to find out, whether a tumour progression or a recurrent tumour can be earlier detected than by standard MR imaging.
Brief summary in scientific language
Mesoscopic Imaging shall be applied to human brain tumours to investigate the microscopic behaviour of tumour growth. The aim is to detect a tumour infiltration earlier than by standard imaging. In a first step, patients with gliomas shall be investigated in advance to a stereotactic biposy. The tumour borders of the histology and the mesoscopic metrics (e. g. extra-axial diffusivity and capillary size) will be compared for a differentiation of patterns of tumour growth. In a second step, patients will receive follow-up investiations to find out, whether a recurrent tumour can be earlier detected by mesoscopic imaging than by standard MR imaging.
Health condition or problem studied
- ICD10:
- C71.9 - Brain, unspecified
- ICD10:
- D43.2 - Brain, unspecified
- Healthy volunteers:
- No Entry
Interventions, Observational Groups
- Arm 1:
- In this single arm study, mesoscopic imaging of gliomas wil be performed before stereotactic biopsy. Tumour borders from histology will be compared to mesoscopic metrics (extraaxial water and vessel size) to find out, how tumour infiltration changes those parameters (primary endpoint). In the follow-up, mesoscopic imaging will be performed in a 3-monthly interval. In case of a tumour progression according to RANO criteria (secondary endpoint) it will be analysed, whether mesoscopic imaging was able to detect progessive disease earlier than standard MR imaging.
Endpoints
- Primary outcome:
- Stereotactic biopsy: comparison of histologically proven infiltration and mesoscopic parameters
- Secondary outcome:
- Tumour progression according to RANO criteria within the 3-monthly follow-up investigations. The time point of progressive disease is individual for each participant.
Study Design
- Purpose:
- Diagnostic
- Retrospective/prospective:
- No Entry
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- No Entry
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting stopped (after recruiting started)
- Reason if recruiting stopped or withdrawn:
- The PI of the study has left the institution. The study is cancelled.
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Freiburg im Breisgau
Recruitment period and number of participants
- Planned study start date:
- 2014-07-01
- Actual study start date:
- 2014-07-01
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 36
- Final Sample Size:
- 37
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 18 Years
- Maximum Age:
- 85 Years
- Additional Inclusion Criteria:
- Patients with suspected glioma (low grade, anaplastic,GBM) prior to stereotactic biopsy - Patients with a known but presumably progressive glioma prior to re-biopsy
Exclusion Criteria
Unability to cosent - Minor - Any contraindication against MRI - Renal Insufficiency (GFR < 30 ml/min x 1.73)
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum FreiburgHugstetter Strasse 4979095 FreiburgGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitätsklinikum Freiburg - Klinik für NeuroradiologieProf. Dr. Irina MaderBreisacher Str. 6479106 FreiburgGermany
- Telephone:
- 0761 270 51920
- Fax:
- 0761 270 54680
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de/neurozentrum/live/index.html
Contact for Public Queries
- Address:
- Universitätsklinikum Freiburg - Klinik für NeuroradiologieUlrike BergmannBreisacher Str. 6479106 FreiburgGermany
- Telephone:
- 0761 270 51930
- Fax:
- 0761 270 51140
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de/neurozentrum/live/index.html
Principal Investigator
- Address:
- Universitätsklinikum Freiburg - Klinik für NeuroradiologieProf. Dr. Irina MaderBreisacher Str. 6479106 FreiburgGermany
- Telephone:
- 0761 270 51920
- Fax:
- 0761 270 54680
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de/neurozentrum/live/index.html
Sources of Monetary or Material Support
Public funding institutions financed by tax money/Government funding body (German Research Foundation (DFG), Federal Ministry of Education and Research (BMBF), etc.)
- Address:
- Deutsche ForschungsgemeinschaftKennedyallee 4053175 BonnGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.dfg.de
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinikum Freiburg - Dept. für Radiologische Diagnostik und Therapie - Klinik für NeuroradiologieBreisacher Str. 6479106 FreiburgGermany
- Telephone:
- 0761 270 51810
- Fax:
- 0761 270 51950
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.uniklinik-freiburg.de/neurozentrum/live/index.html
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission der Albert-Ludwigs-Universität FreiburgEngelberger Str. 2179106 FreiburgGermany
- Telephone:
- +49-761-27072600
- Fax:
- +49-761-27072630
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Vote of leading Ethics Committee
- Vote of leading Ethics Committee
- Date of ethics committee application:
- 2013-12-05
- Ethics committee number:
- 06/14
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2014-01-28
Further identification numbers
- Other primary registry ID:
- No Entry
- EudraCT Number:
- No Entry
IPD - Individual Participant Data
- Do you plan to make participant-related data (IPD) available to other researchers in an anonymized form?:
- No Entry
- IPD Sharing Plan:
- No Entry
Study protocol and other study documents
- Study protocols:
- No Entry
- Study abstract:
- No Entry
- Other study documents:
- No Entry
- Background literature:
- No Entry
- Related DRKS studies:
- No Entry
Publication of study results
- Planned publication:
- No Entry
- Publikationen/Studienergebnisse:
- No Entry
- Date of first publication of study results:
- No Entry
- DRKS entry published for the first time with results:
- No Entry
Basic reporting
- Basic Reporting / Results tables:
- No Entry
- Brief summary of results:
- No Entry