- ICH GCP
- 미국 임상 시험 레지스트리
- 임상시험 NCT01621906
18F-FLT-PET Imaging of the Brain in Patients With Metastatic Breast Cancer to the Brain Treated With Whole Brain Radiation Therapy With or Without Sorafenib: Comparison With MR Imaging of the Brain
Pilot Study of 18F-FLT-PET Imaging of the Brain in Patients With Metastatic Breast Cancer to the Brain Treated With Whole Brain Radiation Therapy With or Without Sorafenib: Comparison With MR Imaging of the Brain
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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New Jersey
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Basking Ridge, New Jersey, 미국
- Memoral Sloan Kettering Cancer Center
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Middletown, New Jersey, 미국, 07748
- Memorial Sloan Kettering Monmouth
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New York
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Commack, New York, 미국, 11725
- Memorial Sloan Kettering Cancer Center @ Suffolk
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Harrison, New York, 미국, 10604
- Memorial Sloan Kettering Westchester
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New York, New York, 미국, 10065
- Memorial Sloan Kettering Cancer Center
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Rockville Centre, New York, 미국
- Memorial Sloan Kettering at Mercy Medical Center
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
Inclusion Criteria:
- Histologically-confirmed (confirmation done at MSKCC) metastatic adenocarcinoma of the breast
- Radiologic evidence of new and/or progressive brain metastases ((≥10 mm in longest dimension) by MRI imaging of the Brain
- Planned WBRT based on number (≥ 3 lesions) and/or size (≥ 1 cm) of brain metastases.
- Age ≥18 years; males and females
- Patients who require additional clinically indicated stereotactic radiosurgery (SRS) in addition to WBRT will also be eligible.
- Life expectancy of >12 weeks.
- Karnofsky Performance Status (KPS) ≥ 70%.
- Creatinine ≤2.0 times the upper limit of normal.
- Women of childbearing potential must have a negative serum pregnancy test performed within 7 days prior to enrollment, must be non-lactating and must agree to use adequate contraception prior to enrollment and for the duration of study participation.
- No limit to prior therapies with last anti-cancer treatment ≥2 weeks from initiation of WBRT. Please note: there is no washout period required for trastuzumab, pertuzumab, for patients who have developed new parenchymal brain metastases while on these agents.
Exclusion Criteria:
- Leptomeningeal metastases Please note: leptomeningeal metastases may be allowed if it is limited to cranial metastasis (MRI spine should be completed, within 4 weeks of enrollment, to show that no other leptomeningeal metastases is present) and is not the only metastasis present in the brain.
- Concurrent administration of lapatinib or other tyrosine kinase inhibitors other than sorafenib
- Craniotomy or any other major surgery, open biopsy, or significant traumatic injury within 4 weeks of randomization.
- Concurrent anti-cancer therapy (chemotherapy, hormonal therapy, radiation therapy, surgery, immunotherapy, biologic therapy, or tumor embolization) other than sorafenib, and protocol-specified whole-brain radiotherapy.
- Use of any investigational drug within 30 days or 5 half-lives, whichever is longer, preceding enrollment.
- Inability to comply with protocol and /or not willing or not available for follow-up assessments.
- Any condition which in the investigator's opinion makes the patient unsuitable for the study participation.
- Patient is incontinent of urine or stool (which would make them unable to tolerate lying still for 60 minutes).
- Claustrophobia
- Known allergic reaction to Gd-DTPA
- Renal insufficiency with recent (<3 month old) creatinine >2.0
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 특수 증상
- 할당: 무작위화되지 않음
- 중재 모델: 병렬 할당
- 마스킹: 없음(오픈 라벨)
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
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실험적: Cohort 1
Cohort 1 will include the first ten patients treated with WBRT concomitantly with sorafenib (on a separate phase I trial).
We will perform a pilot study of serial FLT-PET imaging of the brain at baseline (< 4 weeks prior to initiation of WBRT), up to 7-10 days post-WBRT and 10-12 weeks after WBRT in patients with metastatic breast cancer to the brain (N=20) treated with WBRT with or without sorafenib.
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All patients will be imaged using FLT-PET scans at baseline (within 4 weeks of initiation of WBRT), 7-10 days after completion of WBRT and then 10-12 weeks after WBRT. Patients will also be evaluated with MRI imaging at baseline and then 10-12 weeks after WBRT. Patients will be followed with MRI every 3 months (+/- 7 days) for the first year and then every 6 months (+/- 7 days) thereafter which is the standard of care. |
실험적: Cohort 2
Cohort 2 will include patients treated with standard WBRT alone.
Patients in both these cohorts will also be assessed with standard non-invasive MRI in addition to [18F] FLT PET at baseline (< 4 weeks of WBRT) and 10-12 weeks after completion of WBRT.
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All patients will be imaged using FLT-PET scans at baseline (within 4 weeks of initiation of WBRT), 7-10 days after completion of WBRT and then 10-12 weeks after WBRT. Patients will also be evaluated with MRI imaging at baseline and then 10-12 weeks after WBRT. Patients will be followed with MRI every 3 months (+/- 7 days) for the first year and then every 6 months (+/- 7 days) thereafter which is the standard of care. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Overall Response Rate
기간: 1 year
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Overall Response Rate is the proportion of participants who had a complete or partial response (Cohort 1)
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1 year
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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
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Change in Avg SUV Max From Baseline to 1 Year
기간: 1 year
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Comparing FLT PET findings with tissue analysis will enable us to determine if imaging results are concordant with histological findings and thus allow for confirmation of this hypothesis.
In this manner, we propose to generate a bridge between tissue analysis and FLT-PET brain imaging studies.
For patients needing to undergo craniotomy for resection of a brain metastasis after WBRT, tissue findings (radionecrosis versus viable tumor) will be correlated with radiologic assessment in an exploratory manner.
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1 year
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공동 작업자 및 조사자
수사관
- 수석 연구원: Andrew Seidman, MD, Memorial Sloan Kettering Cancer Center
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작 (실제)
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. .
18F-FLT-PET Imaging에 대한 임상 시험
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University of Texas Southwestern Medical Center빼는
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University of IowaNational Cancer Institute (NCI); National Institutes of Health (NIH)완전한
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National Cancer Centre, Singapore모병
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Abramson Cancer Center of the University of Pennsylvania완전한
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Columbia UniversityMerck Sharp & Dohme LLC종료됨
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Hamad Medical Corporation알려지지 않은본태성혈소판증 | 원발성 골수 섬유증, 섬유화 전 단계 | 원발성 골수 섬유증, 섬유화 단계카타르
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Hamad Medical Corporation종료됨진성적혈구증가증 | 본태성혈소판증 | 원발성 골수 섬유증, 섬유화 전 단계 | 원발성 골수 섬유증, 섬유화 단계카타르
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UNC Lineberger Comprehensive Cancer Center빼는