- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00603057
Using Imaging and Molecular Markers to Predict Tumor Response and Lung Toxicity in Lung Cancer
Using Functional Image and Circulating Molecular Markers to Predict Tumor Response and Lung Toxicity in Treatment of Lung Cancer
Successful treatment of non-small cell lung cancer with radiation therapy requires that the physicians determine exactly where the tumor is in your body and protect your normal tissue. This study is designed to apply functional imaging, Fluorodeoxyglucose-Positron Emission Tomography (FDG-PET) and Ventilation/Perfusion Single Photon Emission Computerized Tomography (V/Q SPECT), before treatment and then again during treatment to see if it helps predict how well the treatment works for your cancer and how well your lung functions during treatment. A Computerized Tomography (CT) will also be performed along with both of these procedures to help the researchers see clearly where your cancer or your healthy lung is located.
The researchers are also doing blood tests in this study to look for markers in your blood and to see if it helps them in determining your risk of developing side effects from radiation to the lungs. The researchers hope that this study will help them in the future to design radiation treatment plans that provide the best treatment for each individual patient.
연구 개요
상태
정황
상세 설명
연구 유형
등록 (실제)
연락처 및 위치
연구 장소
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Michigan
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Ann Arbor, Michigan, 미국, 48109
- University of Michigan
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
샘플링 방법
연구 인구
설명
Inclusion Criteria:
- Histologically confirmed Non Small Cell Lung Cancer (NSCLC) or Small Cell Lung Cancer (SCLC) clinically diagnosed providing that FDG-PET is positive.
- Stage I to III lung cancer requiring definitive irradiation with or without chemotherapy.
- Patients with a locoregional tumor recurrence following surgery will be eligible provided they meet other eligibility criteria.
- Patients must be 18 years of age or older.
- Female patients with reproductive capability must be willing to use effective contraception
- Patients must sign an informed consent form for study.
Exclusion Criteria:
- Malignant pleural or pericardial effusion.
- Pregnancy
- Lactation
- Patients with diabetes mellitus, with uncontrolled fasting blood glucose level (above 200 mg/dl)
- Inability to lie flat for the duration of PET/CT and V/Q SPECT (approximately 45 minutes for each study)
- Prisoners are excluded from this study.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
코호트 및 개입
그룹/코호트 |
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Lung Cancer Imaging Patients
Adult patients (>18 years of age)with histologically confirmed or clinically diagnosed lung cancer who require radiation therapy, with or without surgery and with or without chemotherapy.
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연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
기간 |
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The primary aim of this study is to investigate predictive models for long-term tumor control and late treatment lung toxicity by using FDG-PET-CT, V/Q SPECT-CT and blood tests during the course of radiation therapy.
기간: During treatment with radiation at 40-50 Gy and up to 5 yrs after radiation completed
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During treatment with radiation at 40-50 Gy and up to 5 yrs after radiation completed
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공동 작업자 및 조사자
수사관
- 수석 연구원: Shruti Jolly, M.D., University of Michigan
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. .
비소세포폐암에 대한 임상 시험
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Millennium Pharmaceuticals, Inc.완전한GCB(Non-Germinal B-cell-like) 미만성 거대 B-세포 림프종(DLBCL)미국