- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT00005082
Magnetic Resonance Imaging in Determining Extent of Cancer in Patients With Newly Diagnosed Glioma
Magnetic Resonance Correlates of Glioma Tumor Burden
RATIONALE: New imaging procedures such as magnetic resonance imaging may improve the ability to detect the extent of newly diagnosed cancer.
PURPOSE: Diagnostic study of magnetic resonance imaging to determining the extent of cancer in patients who have newly diagnosed glioma.
연구 개요
상세 설명
OBJECTIVES: I. Determine whether proton magnetic resonance spectroscopic imaging (1H-MRSI) and diffusion magnetic resonance imaging (DI) measures of glioma cell burden correlate with histopathologically measured cell counts in glioma patients who are scheduled to undergo surgical resection. II. Determine whether 1H-MRSI and DI measures of glioma cell burden are invariant over the short term (1 week) as steroid dose is increased in these patients.
OUTLINE: Part I: Patients who are scheduled to have surgical resection of brain tumor undergo conventional magnetic resonance imaging (MRI), proton magnetic resonance spectroscopic imaging (1H-MRSI), and diffusion magnetic resonance imaging (DI) within 1 week before resection. Patients undergo conventional MRI within 72 hours after completion of surgical resection. Image characteristics of the resected tissue are correlated with histopathological measures. Part II: Patients who have clinical indications for increasing the dexamethasone dose are treated on part II of the study. Patients are stratified by status of steroid treatment (steroid naive vs prior steroid management). Patients undergo conventional MRI, 1H-MRSI, and DI within 2 days before and within 4-7 days after increasing the dexamethasone dose. Image characteristics on films taken before and after increasing the dexamethasone dose are compared.
PROJECTED ACCRUAL: A total of 75 patients will be accrued for part I of the study and a total 40 patients (20 per stratum) will be accrued for part II of the study within 4 years.
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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California
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Los Angeles, California, 미국, 90095-1781
- Jonsson Comprehensive Cancer Center, UCLA
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
DISEASE CHARACTERISTICS: Part I: Presurgical: presumptive diagnosis of intracranial glioma and scheduled to undergo first surgical resection OR stereotactic biopsy Postsurgical: Histologically proven intracranial glioma and scheduled to undergo surgical debulking Evaluable preoperative proton magnetic resonance spectroscopic imaging (1H-MRSI) and diffusion magnetic resonance imaging (DI) scans completed within 1 week prior to surgery Postoperative MRI, 1H-MRSI, and DI scans completed within 3 days after surgery Part II: Presurgical: presumptive diagnosis of intracranial glioma Postsurgical: Histologically proven intracranial glioma No surgery prior to completion of exit scans Clinical indication for increasing steroid dose Planned steroid changes must be from 0 to 16 mg/day or a twofold increase Evaluable 1H-MRSI and DI scans No prior treatment on this protocol Parts I and II: No contraindications for magnetic resonance imaging (MRI) (metallic implants, shrapnel fragments, claustrophobia, allergy to MRI contrast)
PATIENT CHARACTERISTICS: Age: Parts I and II: Over 18 Performance status: Parts I and II: Not specified Life expectancy: Parts I and II: Not specified Hematopoietic: Parts I and II: Not specified Hepatic: Parts I and II: Not specified Renal: Parts I and II: Not specified
PRIOR CONCURRENT THERAPY: Biologic therapy: Parts I and II: Not specified Chemotherapy: Parts I and II: Not specified Endocrine therapy: Part I: Not specified Part II: Steroid naive or prior steroid management allowed Radiotherapy: Parts I and II: See Disease Characteristics Surgery: Part I: See Disease Characteristics No information from more than 2 surgeries from any one patient Part II: See Disease Characteristics
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
공동 작업자 및 조사자
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 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 연구와 관련된 용어
키워드
추가 관련 MeSH 약관
기타 연구 ID 번호
- CDR0000067691
- UCLA-9808001
- NCI-G00-1725
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. .