KCT0008590招募中Unknown
A phase 2, open-label, non-randomized, single center study to explore diagnostic performance of [18F]fluoroestradiol (FES) positron emission tomography/computed tomography for the assessment of axillary lymph node metastasis in invasive lobular carcinoma of the breast
试验速览
- 阶段
- Unknown
- 状态
- 招募中
- 入组人数
- 30
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
- 年龄范围
- 19(Year) 至 o Limit（—）
- 性别
- All
入选标准
- •Male or female subjects aged 19 years or olderregardless of race/ethnicity.
- •- Subjects with histologically confirmed estrogenreceptor-positive invasive lobular breast cancerwithin 90 days prior to [18F]FES PET/CTimaging
- •- Subjects whose primary tumor of cT1-3according to the American Joint Committee onCancer (AJCC) 8th tumor staging system
- •- Subjects with suspected or confirmed axillarylymph node metastasis clinically or in imagingtest (ultrasound)
- •- Subjects who scheduled to undergo sentinelnode biopsy or axillay lymph node dissectionwithin 90 days of [18F]FES PET/CT imaging
- •- Subjects whose Eastern Cooperative OncologyGroup (ECOG) performance status (PS) of 2points or less
排除标准
- •- Subject or the subject's legally acceptablerepresentative does not provide writteninformed consent form
- •- Subjects with confirmed or suspected large,bulky, matted cN2 or cN3 axillary lymph nodemetastases, or distant metastases.
- •- Previous history of ipsilateral axillary lymphnode dissection, sentinel lymph node surgery,or lymph node dissection biopsy.
- •- Patients who are scheduled for or haveundergone chemotherapy, radiotherapy,antihormone therapy, targeted therapy, orimmunotherapy between [18F]FES PET/CT andpathological diagnosis
- •- Subjects who are pregnant or lactating.Exclusion of the possibility of pregnancy ismade by one of the following: 1)Physiologically menopausal (menstruation hasstopped for more than 2 years), 2) Surgicallyinfertility (with a history of bilateral oophorectomy or hysterectomy), 3) In the caseof subjects with a possibility of pregnancy,negative serum or urine pregnancy test beforeadministration of [18F]FES has to be negativewithin 24 hours, and the subjects are instructedto use contraception during her participation inthis study.
- •- Subject has concurrent severe and/oruncontrolled and/or unstable medical conditionother than cancer (e.g., congestive heart failure,acute myocardial infarction, severe lungdisease, chronic kidney disease or chronic liverdisease).
- •- Subject is a relative or student of theinvestigator or otherwise in a dependentrelationship
- •- Subject has already participated in this study
- •- Subject not being able to provide intact datafor this study due to personal circumstances orother reasons in the judgment of theinvestigator
研究者
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