Feasibility of ExAblate MRI Guided High Intensity Focused Ultrasound Tx of Soft Tissue Tumors
2018년 4월 28일 업데이트: Pejman Ghanouni
A Feasibility Study to Evaluate the Safety and Effectiveness of ExAblate Magnetic Resonance Imaging Guided High Intensity Focused Ultrasound Treatment of Soft Tissue Tumors of the Extremities
The goal of this project is to evaluate the safety and preliminary efficacy of ExAblate magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) surgery in the treatment of soft tissue tumors of the extremities.
연구 개요
상세 설명
Given that the incidence of cancer increases with age, the number of elderly patients diagnosed and treated for soft tissue sarcomas (STS) will increase.
The dilemma is that surgeons and medical oncologists may be hesitant to treat elderly patients in a comparably intensive manner as is used in the treatment of younger patients; factors such as decreased performance status, significant comorbidities, and disease natural history may erode enthusiasm for aggressive STS resection.
To this end, a less invasive way of treating soft tissue tumors would be helpful in younger patients to minimize morbidity and in the elderly to provide less aggressive treatment options.
The InSightec ExAblate 2000 magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue (5-10).
The ExAblate combines a focused ultrasound surgery (FUS) delivery system and a conventional diagnostic 1.5 T or 3 T MRI scanner.
It provides a real-time therapy planning algorithm, thermal dosimetry, and closed-loop therapy control.
연구 유형
중재적
등록 (실제)
5
단계
- 해당 없음
연락처 및 위치
이 섹션에서는 연구를 수행하는 사람들의 연락처 정보와 이 연구가 수행되는 장소에 대한 정보를 제공합니다.
연구 장소
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California
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Stanford, California, 미국, 94305
- Stanford University School of Medicine
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참여기준
연구원은 적격성 기준이라는 특정 설명에 맞는 사람을 찾습니다. 이러한 기준의 몇 가지 예는 개인의 일반적인 건강 상태 또는 이전 치료입니다.
자격 기준
공부할 수 있는 나이
10년 이상 (어린이, 성인, 고령자)
건강한 자원 봉사자를 받아들입니다
아니
연구 대상 성별
모두
설명
INCLUSION CRITERIA
- ≥ 10 years of age.
- Benign or malignant soft tissue tumors of the extremities, flanks, pelvis, or shoulders requiring surgical intervention.
- Tumor must not have been treated previously with radiation.
- Targeted tumor(s) are accessible to the ExAblate device
- Targeted volume within the tumor is located deeper than 1 cm from the skin
- Targeted tumor is clearly visible by non-contrast magnetic resonance imaging (MRI)
- Karnofsky Performance Status > 60
- Normal platelet count and coagulation profile
- Glomerular filtration rate > 60 mL/min
- Able to safely undergo MRI exam and receive mild sedation for the treatment.
- Able to tolerate being in the MRI scanner for the duration of the study.
- Able and willing to give consent (or consent + assent where applicable), and able to attend all study visits.
EXCLUSION CRITERIA
- Previous radiation treatment to the tumor.
- Currently receiving dialysis.
- Acute medical condition (eg, pneumonia, sepsis) expected to hinder completion of the study
Unstable cardiac status including:
- Unstable angina pectoris on medication
- Patients with documented myocardial infarction within six months of protocol entry
- Congestive heart failure requiring medication (other than diuretic)
- Patients on anti-arrhythmic drugs
- Severe hypertension (diastolic BP > 100 on medication)
- Contraindication for MR imaging such as implanted metallic devices that are not MRI-safe, size limitations, etc
- Severe hematologic, neurologic, or other uncontrolled disease
- Known intolerance or allergy to medications used for sedation (midazolam), analgesia (fentanyl), and local and regional anesthesia (lidocaine, bupivacaine, and ropivacaine)
- Known intolerance or allergy to MR contrast agent (gadolinium chelates) including advanced kidney disease
- Pregnant and nursing
- Karnofsky Performance Score < 60
- Severe cerebrovascular disease [cardiovascular accident (CVA) within 6 months]
- Not able or not willing to tolerate the required prolonged stationary position during treatment (up to 5 hrs of total table time)
- Target volume in tumor is less than 1 cm from neurovascular bundles, major blood vessels, bowel, or bladder.
Targeted tumors:
- NOT visible by non-contrast MRI, OR
- NOT accessible to ExAblate device
- Not a candidate for either regional anesthesia or mild sedation
- Not be participating in another trial testing other investigational agents or devices
공부 계획
이 섹션에서는 연구 설계 방법과 연구가 측정하는 내용을 포함하여 연구 계획에 대한 세부 정보를 제공합니다.
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 해당 없음
- 중재 모델: 단일 그룹 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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실험적: MRgHIFU
The InSightec ExAblate 2000 magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system is a non-invasive device that is fully integrated with an MR imaging system and used for the ablation of soft tissue.
The treatment process begins with the physician acquiring a set of MR images, identifying 1+ target volume(s) of fibroid tissue to be ablated, and drawing the treatment contours.
The therapy planning software computes the type and number of sonications required to treat the defined volume while minimizing total treatment time.
MR images taken during the sonication provide a diagnostic quality image of the target tissue and a quantitative, real-time temperature map overlay to confirm the therapeutic effect of the treatment.
The transducer is then automatically moved to the succeeding treatment point and the process is repeated until the entire volume has been treated.
About 100 individual sonications can be delivered over a 3-hour period to complete a treatment.
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The InSightec ExAblate 2000 magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) system is a non-invasive thermal ablation device fully integrated with an MR imaging system and used for the ablation of soft tissue
다른 이름들:
325 mg PO for deep venous thrombosis (DVT) prophylaxis initiated 2 hours prior to magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) treatment
다른 이름들:
40 mg by subcutaneous (SC) administration, for deep venous thrombosis (DVT) prophylaxis initiated 2 hours prior to magnetic resonance-guided high-intensity focused ultrasound (MRgHIFU) treatment
다른 이름들:
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Overall Safety - Incidence of Any Device-related Adverse Events
기간: 1 week
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Safety determined by evaluating for the incidence of any device-related adverse events.
Patients will be assessed for pain and limb function, and by clinical examination before and after treatment to collect adverse events related to the treatment.
Safety is reported as the total incidence of device-related adverse events.
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1 week
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Adverse Event Severity
기간: 6 months
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Safety is further assessed by an evaluation of severity for the treatment-related adverse events, reported as the number of adverse events for each of the Common Terminology Criteria for Adverse Events (CTCAE) v4.0 grades. CTCAE Severity:
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6 months
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Percent Successful Tumor Ablation
기간: Up to 1 week
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In the resected tumor specimen, the volume of the ablated area will be determined by obtaining a digital photograph of each pathology slice.
The region of interest corresponding to the ablated area will be traced, and the ablated area will be calculated for each slice and summed.
Accuracy is assessed as the percent ablated volume relative to pre-treatment tumor volume.
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Up to 1 week
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공동 작업자 및 조사자
여기에서 이 연구와 관련된 사람과 조직을 찾을 수 있습니다.
스폰서
수사관
- 수석 연구원: Pejman Ghanouni, MD, PhD, Stanford University
- 수석 연구원: Raffi Avedian, MD, Stanford University
연구 기록 날짜
이 날짜는 ClinicalTrials.gov에 대한 연구 기록 및 요약 결과 제출의 진행 상황을 추적합니다. 연구 기록 및 보고된 결과는 공개 웹사이트에 게시되기 전에 특정 품질 관리 기준을 충족하는지 확인하기 위해 국립 의학 도서관(NLM)에서 검토합니다.
연구 주요 날짜
연구 시작
2014년 5월 1일
기본 완료 (실제)
2015년 3월 24일
연구 완료 (실제)
2015년 3월 24일
연구 등록 날짜
최초 제출
2013년 10월 15일
QC 기준을 충족하는 최초 제출
2013년 10월 15일
처음 게시됨 (추정)
2013년 10월 17일
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
2018년 5월 23일
QC 기준을 충족하는 마지막 업데이트 제출
2018년 4월 28일
마지막으로 확인됨
2018년 4월 1일
추가 정보
이 연구와 관련된 용어
추가 관련 MeSH 약관
기타 연구 ID 번호
- IRB-26667
- VAR0095 (기타 식별자: OnCore)
개별 참가자 데이터(IPD) 계획
개별 참가자 데이터(IPD)를 공유할 계획입니까?
아니요
약물 및 장치 정보, 연구 문서
미국 FDA 규제 기기 제품 연구
예
이 정보는 변경 없이 clinicaltrials.gov 웹사이트에서 직접 가져온 것입니다. 귀하의 연구 세부 정보를 변경, 제거 또는 업데이트하도록 요청하는 경우 register@clinicaltrials.gov. 문의하십시오. 변경 사항이 clinicaltrials.gov에 구현되는 즉시 저희 웹사이트에도 자동으로 업데이트됩니다. .
연조직 신생물에 대한 임상 시험
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Centre Leon Berard아직 모집하지 않음연조직 육종(Soft Tissue Sarcoma, STS) 진단프랑스
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Kirsehir Ahi Evran Universitesi완전한
MRgHIFU에 대한 임상 시험
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Chin-Jung WangNational Health Research Institutes, Taiwan알려지지 않은