- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00136890
PET Imaging in Potentially Surgically Resectable Non-small Cell Lung Cancers (ELPET)
The Impact of Positron Emission Tomography (PET) Imaging in Staging Potentially Surgically Resectable Non-small Cell Lung Cancers: A Prospective Multicentre Randomized Clinical Trial
Lung cancer remains the leading cause of cancer deaths in men and women. Although overall survival remains poor, early stage non-small cell lung cancer (NSCLC) is potentially curable. Improved staging has led to stage-specific therapies such that patients with early stage NSCLC are potential candidates for surgical resection, and those with more advanced disease are spared the morbidity and risk of mortality from thoracotomy and pulmonary resection. Despite contemporary staging techniques, 25-50% of patients who appear to have limited disease amenable to surgical resection go on to die from metastatic lung cancer. If occult micro-metastatic disease that becomes evident later could be detected reliably during the pre-operative assessment, patients harboring such disease could be spared a non-curative thoracotomy. PET imaging has the potential to detect mediastinal and extrathoracic metastatic disease not detected by conventional imaging modalities.
This prospective, multicenter trial will enroll patients with biopsy-proven clinical stage I-IIIA NSCLC who are considered to be candidates for surgical resection with curative intent. Preoperatively, patients will be randomized to conventional staging for metastatic disease (CT liver/adrenals, total body bone scan, and CT with contrast or MRI with gadolinium of the brain) versus whole body PET or PET-CT and brain CT or MRI with contrast/gadolinium.
연구 개요
연구 유형
등록 (실제)
단계
- 3단계
연락처 및 위치
연구 장소
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Ontario
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Hamilton, Ontario, 캐나다, L8N 4A6
- St. Joseph's Healthcare Hamilton
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London, Ontario, 캐나다, N6A 4G5
- London Health Sciences Centre
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Mississauga, Ontario, 캐나다, L5M 2N1
- Credit Valley
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Ottawa, Ontario, 캐나다, K1H 8L6
- The Ottawa Hospital - General Campus
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Scarborough, Ontario, 캐나다, M1P 2T7
- Scarborough Hospital
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Toronto, Ontario, 캐나다, M5G 2C4
- Toronto General Hospital
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Toronto, Ontario, 캐나다, M4N 3M5
- Sunnybrook/TEGH
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Toronto, Ontario, 캐나다, M6R 1B5
- St. Joseph's Health Care
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histological or cytological proof of NSCLC
- Stage I, II, or IIIA NSCLC based upon clinical staging
- The primary lesion appears technically appropriate for surgical resection, based on information from the chest x-ray (CXR) and CT thorax.
- Age over 18 years
Exclusion Criteria:
- Poor pulmonary function precluding radical surgery (inadequate pulmonary reserve for radical surgery) with predicted post-resection forced expiratory volume in 1 second (FEV1) < 0.8 liter or < 40% predicted, and diffusing capacity of the lung for carbon monoxide (DLCO) < 40% predicted
- Poor performance status (Eastern Cooperative Oncology Group [ECOG] 3-4)
- Significant concurrent medical problems (e.g. uncontrolled diabetes, active cardiac problems, significant chronic obstructive pulmonary disease) making the patient unfit for surgery
- Pregnant or lactating females
- Unable to lie supine for imaging with PET
- Patients with previously treated cancer other than non-melanotic skin cancer or carcinoma in situ of the cervix, unless disease-free for 5 years or greater
- Patients who, at the time of the initial evaluation, have already undergone a whole body PET/PET-CT, CT brain, MRI brain, total body bone scan or mediastinoscopy within 8 weeks prior to randomization will be excluded. However, patients who have had a CT scan of the thorax with abdomen are not excluded.
- Failure to provide informed consent
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
---|---|
간섭 없음: 1
Conventional Staging
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실험적: 2
PET Imaging
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Patients randomized to PET staging will undergo FDG-PET or PET-CT as well as some form of cranial imaging (CT or MRI)
|
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
---|---|
Patients correctly upstaged by PET versus conventional staging
기간: November 2007
|
November 2007
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2차 결과 측정
결과 측정 |
기간 |
---|---|
Patients erroneously understaged by PET versus conventional staging
기간: November 2008
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November 2008
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Overall survival
기간: August 2012
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August 2012
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Prognostic ability of PET standard uptake value
기간: August 2011
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August 2011
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Sensitivity and specificity of PET in the mediastinum
기간: November 2008
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November 2008
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Cost-effectiveness of using PET versus conventional staging
기간: August 2012
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August 2012
|
공동 작업자 및 조사자
수사관
- 수석 연구원: Mark N Levine, MD, Ontario Clinical Oncology Group (OCOG)
- 연구 의자: Donna E Maziak, MD, The Ottawa Hospital
- 연구 의자: Gail E Darling, MD, Toronto General Hospital
- 수석 연구원: William Evans, MD, Juravinski Cancer Centre
간행물 및 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 (추정)
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. .
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