Pre-operative advanced MR imaging in children
Organizational Data
- DRKS-ID:
- DRKS00006738
- Recruitment Status:
- Recruiting ongoing
- Date of registration in DRKS:
- 2014-09-26
- Last update in DRKS:
- 2023-01-18
- Registration type:
- Prospective
Acronym/abbreviation of the study
paMRic-study
URL of the study
No Entry
Brief summary in lay language
Brain tumors are the most common solid tumors in children, and the initial operative therapy determines not only long-term outcome, but also the rate and extent of neurological deficits. This is also true for patients with structural epilepsy. Optimal planning of this operation therefore is crucial; to this effect, advanced imaging methods are most important. Using modern approaches such as functional and diffusion magnetic resonance imaging (fMRI, dMRI), it is possible to identify brain regions involved in certain brain functions. This again allows for a more individual planning of an ensuing operation. These approaches are already in routine use for special indications in adults. However, this is not the case for children in whom these approaches are, for a number of reasons, more difficult to apply. This study is aimed at assessing the routine feasibility of such investigations in children.
Brief summary in scientific language
Brain tumors are the most common solid tumors in children, and the initial operative therapy determines not only long-term outcome, but also the rate and extent of neurological deficits. This is also true for patients with structural epilepsy, as induced by. e.g. malformations of cortical development. Optimal planning of this operation therefore is crucial; to this effect, advanced imaging methods are most important. Using modern approaches such as functional and diffusion magnetic resonance imaging (fMRI, dMRI), it is possible to identify brain regions involved in certain brain functions. This again allows for a more individual planning of an ensuing operation. These approaches are already in routine use for special indications in adults. However, applying these methods in children requires substantial expertise with regard to planning, execution, and interpretation. This combined interdisciplinary expertise is only available in select centers. This study is therefore aimed at assessing the routine feasibility of such investigations in children at a tertiary referral center.
Health condition or problem studied
- Free text:
- brain tumors (benign, malignant, or unclear
- Free text:
- structural epilepsy
- ICD10:
- G40 - Epilepsy
- ICD10:
- D33 - Benign neoplasm of brain and other parts of central nervous system
- ICD10:
- C71 - Malignant neoplasm of brain
- ICD10:
- D43 - Neoplasm of uncertain or unknown behaviour of brain and central nervous system
- Healthy volunteers:
- No
Interventions, Observational Groups
- Arm 1:
- - individually-tailored, pre-operative examination using advanced MR methods - additionally, depending on endangered system, pre- and postoperative language testing, structured clinical exam or opthalmological examination will be performed
Endpoints
- Primary outcome:
- Feasibility of preoperatively examining the language domain using advanced MRI methods (in particular, functional MRI) in children with brain tumors or structural epilepsy. Feasibility is defined as the ratio of successfully performed, interpretable exams.
- Secondary outcome:
- Feasibility of preoperatively examining the sensorimotor and the visual system using advanced MRI methods (in particular, diffusions MR tractography) in children with brain tumors or structural epilepsy. Feasibility is defined as the ratio of successfully performed, interpretable exams.
Study Design
- Purpose:
- Other
- Retrospective/prospective:
- Prospective
- Study type:
- Non-interventional
- Longitudinal/cross-sectional:
- Cross-sectional study
- Study type non-interventional:
- No Entry
Recruitment
- Recruitment Status:
- Recruiting ongoing
- Reason if recruiting stopped or withdrawn:
- No Entry
Recruitment Locations
- Recruitment countries:
-
- Germany
- Number of study centers:
- Monocenter study
- Recruitment location(s):
-
- University medical center Kinderklinik, Abteilung Neuropädiatrie Tübingen
Recruitment period and number of participants
- Planned study start date:
- 2014-09-30
- Actual study start date:
- 2014-11-16
- Planned study completion date:
- No Entry
- Actual Study Completion Date:
- No Entry
- Target Sample Size:
- 80
- Final Sample Size:
- No Entry
Inclusion Criteria
- Sex:
- All
- Minimum Age:
- 6 Years
- Maximum Age:
- 18 Years
- Additional Inclusion Criteria:
- Epileptogenic or tumorous lesion in the central region OR in cortical language regions OR near the optic radiation with given or possible indication for neurosurgery
Exclusion Criteria
- metal implants (vascular clips or coils, orthopedic screws, cardiac pacemakers, shunts) unless explicitly and in writing certified to be MRI compatible - orthodontic brackets (removal may be required for clinically-indicated MRI exams, but will not be performed solely for study-related MRI exams) - history of injuries possibly introducing metal into the body (high-speed trauma, shrapnel, metal workers etc.) - pregnancy (a pregnancy test will be required for all girls > 12 years in case of anamnestic doubts)
Addresses
Primary Sponsor
- Address:
- Universitätsklinikum TübingenGeissweg 372076 TübingenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medizin.uni-tuebingen.de
- Investigator Sponsored/Initiated Trial (IST/IIT):
- Yes
Contact for Scientific Queries
- Address:
- Universitäts-Kinderklinik, Abt. III (Neuropädiatrie)Interdisziplinärer Arbeitsbereich Experimentelle Pädiatrische NeurobildgebungProf. Dr. med. Marko WilkeHoppe-Seyler-Str. 172076 TübingenGermany
- Telephone:
- 07071 29 83416
- Fax:
- 07071 29 5473
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medizin.uni-tuebingen.de/kinder/epn/
Contact for Public Queries
- Address:
- Universitäts-Kinderklinik, Abt. III (Neuropädiatrie)Interdisziplinärer Arbeitsbereich Experimentelle Pädiatrische NeurobildgebungProf. Dr. med. Marko WilkeHoppe-Seyler-Str. 172076 TübingenGermany
- Telephone:
- 07071 29 83416
- Fax:
- 07071 29 5473
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medizin.uni-tuebingen.de/kinder/epn/
Principal Investigator
- Address:
- Universitäts-Kinderklinik, Abt. III (Neuropädiatrie)Interdisziplinärer Arbeitsbereich Experimentelle Pädiatrische NeurobildgebungProf. Dr. med. Marko WilkeHoppe-Seyler-Str. 172076 TübingenGermany
- Telephone:
- 07071 29 83416
- Fax:
- 07071 29 5473
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- http://www.medizin.uni-tuebingen.de/kinder/epn/
Sources of Monetary or Material Support
Institutional budget, no external funding (budget of sponsor/PI)
- Address:
- Universitätsklinikum Tübingen, Kinderklinik, Abteilung IIIHoppe-Seyler-Straße 172076 TübingenGermany
- Telephone:
- No Entry
- Fax:
- No Entry
- Contact per E-Mail:
- Contact per E-Mail
- URL:
- No Entry
Ethics Committee
Address Ethics Committee
- Address:
- Ethik-Kommission an der Medizinischen Fakultät der Eberhard-Karls-Universität und am Universitätsklinikum TübingenGartenstr. 4772074 TübingenGermany
- Telephone:
- +49-7071-2977661
- Fax:
- No Entry
- 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:
- 2014-07-17
- Ethics committee number:
- 420/2012/BO1
- Vote of the Ethics Committee:
- Approved
- Date of the vote:
- 2014-07-21
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
- 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:
- Lorenzen A, Groeschel S, Ernemann U, Wilke M / Schuhmann MU. Role of pre-surgical functional MRI and diffusion MR tractography in pediatric low-grade brain tumor surgeries: a single center study. Child’s Nervous System (2018) 34: 2241-2248 Lorenzen A, Wilke M, Alber M, Milian M, Bornemann A, Ernemann U, Rona S. Multimodal assessment reveals late-onset hemispheric shift of language in a child with meningocerebral dysplasia. Neuropediatrics (2016) 47: 341-345
- Date of first publication of study results:
- 2016-07-27
- DRKS entry published for the first time with results:
- 2023-01-18
Basic reporting
- Basic Reporting / Results tables:
- Wilke M, Groeschel S, Lorenzen A, Rona S, Schuhmann MU, Ernemann U, Krägeloh-Mann I. Clinical application of advanced MR methods in children: points to consider. Ann Clin Transl Neurology (2018) 5: 1434-1455
- Brief summary of results:
- No Entry