Functional Monitoring for Motor Pathway in Brain Tumor Surgery Within Eloquent Area
4. april 2015 oppdatert av: Jinsong Wu, Huashan Hospital
Clinical Efficiency of Motor Pathway Mapping Using Diffusion Tensor Imaging Tractography and Intraoperative Subcortical Stimulation in Cerebral Glioma Surgery
Resection of brain tumors in eloquent areas involves the risk of postoperative motor deficits.
For brain tumors within or adjacent to the eloquent area, maximizing tumor resection while preserving motor function is crucially important.we
used DTI-based tractography to visualize the spatial relationship between brain lesions and the nearby pyramidal tract(PT) in patients with malignant brain tumors and confirmed functional connections of the illustrated PT by direct electrical stimulation.
We evaluated the reliability of DTI-based tractography for PT mapping using intraoperative subcortical stimulation ) and the usefulness of the combination of two techniques.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert beskrivelse
Adverse effects caused by electrical stimulation during the operation were recorded.
All subjects adopted early postoperative MRI examinations (within 3 days) to evaluate both the extent of tumor resection and the integrity of the PTs.
Muscle strength was assessed preoperatively and postoperatively.The Karnofsky Performance Scale (KPS) was adopted for grading functional status at the 6-month evaluation.
Further tumor progression interval and survival analysis was conducted for each subject with high-grade glioma (HGG)
Studietype
Intervensjonell
Registrering (Faktiske)
58
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
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Shanghai
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Shanghai, Shanghai, Kina, 200000
- Hushan Hospital, Fudan University
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
6 år til 75 år (Barn, Voksen, Eldre voksen)
Tar imot friske frivillige
Nei
Kjønn som er kvalifisert for studier
Alle
Beskrivelse
Inclusion Criteria:
- patients with an initial imaging diagnosis of single, unilateral, supratentorial primary glioma (or intrinsic neoplasm).
- The lesions were involved in PTs, comprising cortical regions in the motor or somatosensory areas, cortical regions adjacent to the central gyrus, subcortical regions with an infiltrative progression along the PTs, and temporal or insular regions in relation to the internal capsule.
- MRI enabled preoperative identification of patients in whom maximal tumor resection was likely to be achieved, and close PT approach within resection cavity at the time of surgery was possible.
Exclusion Criteria:
- patients with secondary or recurrent gliomas (or intrinsic neoplasm), patients with contraindications for MRI or direct electrical stimulation, and patients in whom initial muscle strength grades of the affected extremities was 2/5 or lower.
Studieplan
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: N/A
- Intervensjonsmodell: Enkeltgruppeoppdrag
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
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Annen: intraoperative functional monitoring
|
All of the patients underwent tumor resection assisted with combined use of Diffusion tensor tractography-integrated functional neuronavigation and intraoperative subcortical stimulation
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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
|
Extent of Tumor Resection
Tidsramme: within 3 days
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Volumetric analysis was performed both before and after surgery by calculating the tumor volume on the images of enhanced 3-D MP-RAGE sequence for high-grade gliomas and FLAIR sequence for low-grade gliomas.
The extent of tumor resection was the ratio of pre-op tumor volume over post-op tumor volume.
Gross total resection refers to a 100% resection of the tumor volume; near-total resection refers to 95% to 100% resection; subtotal resection refers to 90% to 95% resection; partial resection refers to 75% to 90% resection; and biopsy refers to ,75% resection of the tumor volume for histological diagnosis.
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within 3 days
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Sekundære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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Postoperative Motor Function and Long-time Functional Status
Tidsramme: 3 days to 6 months after surgery
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Motor function was assessed early postoperatively (within 72 hours after the operation), and 1 month after discharge.
The muscle strength of each subject was graded for both the upper and lower extremities with the Medical Research Council Scale.
Grade 5: Muscle contracts against full resistance; Grade 4: Strength reduced, but contraction can still move joint against resistance; Grade 3: Strength further reduced such that joint can be moved only against gravity with examiner's resistance completely removed.
Grade 2: Muscle can onlly move if resistance of gravity is removed.
Grade 1: Only a trace or flicker of movement is seen or felt, or fasciculations are observed; Grade 0:No movement.
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3 days to 6 months after surgery
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Andre resultatmål
Resultatmål |
Tiltaksbeskrivelse |
Tidsramme |
|---|---|---|
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The Specificity, Sentitivity of DTI Tractography and Accordance Rate of DTI With DsCS Results
Tidsramme: During the operation
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The sensitivity of DTI tractography for PT mapping was calculated as the ratio between the number of subjects with positive DsCS results in the positive DTI zone (true positive) and the total number of subjects with positive DsCS results (true positive plus false negative).
The specificity was measured as the ratio between the number of subjects with negative DsCS results in the negative DTI zone (true negative) and the total number of subjects with negative DsCS results (true negative plus false positive).
The accordance rate of DsCS and DTI was measured as the ratio between the number of subjects with either a true-positive or true-negative DsCS result and the total number of subjects.
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During the operation
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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Studiestol: Liangfu Zhou, Doctorate, Huashan Hospital
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. oktober 2008
Primær fullføring (Faktiske)
1. juni 2009
Studiet fullført (Faktiske)
1. februar 2013
Datoer for studieregistrering
Først innsendt
9. mai 2011
Først innsendt som oppfylte QC-kriteriene
9. mai 2011
Først lagt ut (Anslag)
10. mai 2011
Oppdateringer av studieposter
Sist oppdatering lagt ut (Anslag)
20. april 2015
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. april 2015
Sist bekreftet
1. april 2015
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- 07QA14008 (Annet stipend/finansieringsnummer: The govermment of Shanghai, China)
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