- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00705497
Radiofrequency Ablation of Tumors
Radiofrequency Ablation of Tumors (RFA) A Phase I Study
Background: This prospective study was designed to be the first to evaluate the toxicity of radiofrequency ablation (RFA) in patients with recurrent pediatric solid tumors.
Methods: From 2003 through 2006, we conducted a phase I, IRB-approved study of RFA for recurrent solid tumors. A multidisciplinary cancer management team selected appropriate candidates for the study. Imaging-guided RFA was performed percutaneously. Response was assessed at 3 months. Repeat RFA was performed for some incompletely ablated or new lesions.
연구 개요
연구 유형
등록 (실제)
단계
- 1단계
연락처 및 위치
연구 장소
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Tennessee
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Memphis, Tennessee, 미국, 38105
- St. Jude Children's Research Hospital
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참여기준
자격 기준
공부할 수 있는 나이
- 어린이
- 성인
- 고령자
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
General
- Any age
- Previously diagnosed malignancy (including aggressive fibromatosis) originally acquired during childhood (<21 years-of-age)
- Patients who have undergone previous RFA may be enrolled again (different disease site) or receive subsequent ablation (same disease site) as long as the eligibility criteria are met at the time of re-enrollment, or a second ablation on study.
- The subject is medically appropriate for the study as determined by a consensus of professionals at multidisciplinary tumor conference prior to enrollment. This discussion will be documented in the chart of the potential subject to be recruited for this study.
- Histopathological material is available prior to the RF ablation except in patients with obvious tumor recurrence.
- No Pacemakers or Automatic Implantable Cardioverter/Defibrillators (AICDs)
- No tissue burns anticipated from implanted metal
- Normal renal function (Creatinine < 2mg/dL)
- Absolute neutrophil count (ANC) > 1000/cu.mm.
- No uncorrectable coagulopathy (INR>1.5, PTT and PT > 1.5 x the upper limit of normal)
- No uncorrectable thrombocytopenia (platelet count < 50,000/mm3)
- Life expectancy over 30 days
- RF ablation targets in the liver, lung or musculoskeletal system that meet the following criteria:
Hepatic lesions
- Intrahepatic metastases not amenable to other therapy
- Primary hepatic tumor if RF ablation of a portion of the tumor can lead to primary tumor resection rather than hepatic transplantation
- Single primary or multiple tumors in the liver
- At least one over 0.5 cm in diameter
- Edge of lesion not contiguous with main hepatic or common biliary duct.
Musculoskeletal lesions
- Local or regional recurrence of primary bone or soft tissue tumor not amenable to resection or radiotherapy
- Osseous, soft tissue or lymph node metastases not amenable to resection or radiotherapy.
- Head, neck, spine, extremity, chest wall, flank, abdominal wall, or pelvic bone or girdle lesions are treatable under this protocol
- RFA target < 50% of axial area in weight bearing bone unless reinforced with internal fixation (bone cement infusion) or in non-ambulatory patient.
Lung lesions
- No supplemental oxygenation is required.
- Metastatic solid tumor that has recurred or progressed after primary thoracotomy or thoracoscopic removal that is not amenable to radiotherapy, surgery or chemotherapy
- In the investigator's opinion, no supplemental oxygen will likely be required at rest for more than 30 days after RF ablation.
- Tumor burden < 20% of lung volume
공부 계획
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: 1
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Radiofrequency tumor ablation (RFA) is an imaging guided percutaneous or intra-operative procedure that uses a probe on the end of a sharp needle that is inserted directly into the tumor.
The tumor is ablated by heating the probe (using electrical current alternating at radio frequency) which raises the temperature of the tumor potentially causing irreversible cell death.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
|---|---|
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To determine the safety of RFA in patients with childhood acquired tumors
기간: 5 years
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5 years
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공동 작업자 및 조사자
수사관
- 수석 연구원: Matthew Krasin, MD, St. Jude Children's Research Hospital
간행물 및 유용한 링크
유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (실제)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
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. .