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.
연구 개요
상세 설명
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)
연구 유형
등록 (예상)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Zuid-Holland
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Rotterdam, Zuid-Holland, 네덜란드
- Erasmus MC
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: Ultrasound
ultrasound navigation guided surgery.
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during surgery, the neurosurgeon will acquire ultrasound guided images (fused with the standard neuronavigation system) to evaluate the progress of tumor resection.
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간섭 없음: Non-ultrasound
standard surgery without ultrasound guidance.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Gross total resection (Yes or No)
기간: within 48 hours after surgery
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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.
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within 48 hours after surgery
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
|
Extent of resection (%)
기간: within 48 hours after surgery
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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.
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within 48 hours after surgery
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Neurological outcome (Karnofsky Performance status)
기간: within 1 week after surgery
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Karnofsky Performance status
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within 1 week after surgery
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Quality of Life (QLQ C30 questionnaires)
기간: 1, 3 and 6 months after surgery
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QLQ C30 questionnaires A brain tumor specific quality of life measurement tool |
1, 3 and 6 months after surgery
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Quality of Life (QLQ BN20 questionnaires)
기간: 1, 3 and 6 months after surgery
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QLQ BN20 questionnaires A brain tumor specific quality of life measurement tool |
1, 3 and 6 months after surgery
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|
Surgery associated neurological deficits (National Institutes of Health Stroke Scale)
기간: 1 month after surgery
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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
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Survival (time in days)
기간: status will be checked 15 months after surgery
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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
|
공동 작업자 및 조사자
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
기본 완료 (실제)
연구 완료 (예상)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (실제)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- MEC-2015-46
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
약물 및 장치 정보, 연구 문서
미국 FDA 규제 의약품 연구
미국 FDA 규제 기기 제품 연구
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