Intraoperative Ultrasound Guided Glioma Surgery; a Randomised, Controlled Trial. (US-GLIOMA)
Intraoperative Ultrasound Guidance and Extent of Resection in High Grade Glioma Surgery: a Randomised, Controlled Trial.
Studieoversigt
Detaljeret beskrivelse
Study design:
The US-GLIOMA study is a randomized controlled trial with blinded primary outcome measure.
Study population:
Fifty patients with newly diagnosed contrast enhancing presumed high grade glioma on first MRI scan.
Intervention:
The study consists of two treatment arms: non-ultrasound guided glioma resection (conventional treatment) versus ultrasound guided glioma resection (intervention) .
Main study parameters/endpoints:
- Gross total resection (yes/no)
- Extent of resection (%)
- Neurological outcome (Karnofsky Performance Status)
- Quality of Life (EORTC QLQ-C30 and QLQ-BN20 quality of life questionnaire)
- Surgery associated neurological deficits (National Institutes of Health Stroke Scale)
- Adverse events (classified according to the US National Cancer Institute common toxicity criteria version 4.0)
- Survival time (days)
Undersøgelsestype
Tilmelding (Forventet)
Fase
- Ikke anvendelig
Kontakter og lokationer
Studiesteder
-
-
Zuid-Holland
-
Rotterdam, Zuid-Holland, Holland
- Erasmus MC
-
-
Deltagelseskriterier
Berettigelseskriterier
Aldre berettiget til at studere
Tager imod sunde frivillige
Køn, der er berettiget til at studere
Beskrivelse
Inclusion Criteria:
- Individuals of 18 years or older
- Newly diagnosed, untreated, contrast enhancing presumed high-grade glioma
- KPS ≥ 60
- Preoperative intention to perform gross-total resection of the enhancing tumor
- Written informed consent conform ICH-GCP
Exclusion Criteria:
- Tumours crossing the midline basal ganglia, cerebellum, or brain stem prohibiting gross total resection
- Multifocal contrast enhancing lesions
- Pre-existing neurological deficit (e.g. aphasia, hemiparesis) due to neurological diseases (e.g. stroke)
- Inability to give consent because of dysphasia or language barrier
Studieplan
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Ultrasound
ultrasound navigation guided surgery.
|
during surgery, the neurosurgeon will acquire ultrasound guided images (fused with the standard neuronavigation system) to evaluate the progress of tumor resection.
|
|
Ingen indgriben: Non-ultrasound
standard surgery without ultrasound guidance.
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Gross total resection (Yes or No)
Tidsramme: within 48 hours after surgery
|
Gross-total resection (yes vs. no): No residual contrast enhancement on post-operative MRI scans; 100% of all contrast enhancing tumor has been resected when compared to initial enhancing tumor on pre-operative MRI scans.
|
within 48 hours after surgery
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Extent of resection (%)
Tidsramme: within 48 hours after surgery
|
as a continous variable The extent of resection (%) is a secondary outcome measurement defined as the residual tumor volumes on post-operative MRI studies compared to the operative tumor volume.
|
within 48 hours after surgery
|
|
Neurological outcome (Karnofsky Performance status)
Tidsramme: within 1 week after surgery
|
Karnofsky Performance status
|
within 1 week after surgery
|
|
Quality of Life (QLQ C30 questionnaires)
Tidsramme: 1, 3 and 6 months after surgery
|
QLQ C30 questionnaires A brain tumor specific quality of life measurement tool |
1, 3 and 6 months after surgery
|
|
Quality of Life (QLQ BN20 questionnaires)
Tidsramme: 1, 3 and 6 months after surgery
|
QLQ BN20 questionnaires A brain tumor specific quality of life measurement tool |
1, 3 and 6 months after surgery
|
|
Surgery associated neurological deficits (National Institutes of Health Stroke Scale)
Tidsramme: 1 month after surgery
|
National Institutes of Health Stroke Scale 0 No stroke symptoms 1-4 Minor stroke 5-15 Moderate stroke 16-20 Moderate to severe stroke 21-42 Severe stroke NIHSS is a tool used by healthcare providers to objectively quantify the impairment caused typically by a stroke, however it is also used for tumor studies to assess functioning on the level of speech, motor and sensory functions. |
1 month after surgery
|
|
Survival (time in days)
Tidsramme: status will be checked 15 months after surgery
|
time measured from surgery until death in days. This study has a follow up of 6 months. However, when patients are alive at months after surgery, we will contact the general practictioner of the patient 15 months after the trial to obtain survival data. |
status will be checked 15 months after surgery
|
Samarbejdspartnere og efterforskere
Sponsor
Samarbejdspartnere
Publikationer og nyttige links
Datoer for undersøgelser
Studer store datoer
Studiestart (Faktiske)
Primær færdiggørelse (Faktiske)
Studieafslutning (Forventet)
Datoer for studieregistrering
Først indsendt
Først indsendt, der opfyldte QC-kriterier
Først opslået (Faktiske)
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
Sidst verificeret
Mere information
Begreber relateret til denne undersøgelse
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- MEC-2015-46
Plan for individuelle deltagerdata (IPD)
Planlægger du at dele individuelle deltagerdata (IPD)?
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
Studerer et amerikansk FDA-reguleret lægemiddelprodukt
Studerer et amerikansk FDA-reguleret enhedsprodukt
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .