跳至主要内容
临床试验/NCT03349463
NCT03349463Unknown4 期

Evaluation of Fluciclovine Uptake in Patients With Cervical, Ovarian Epithelial or Endometrial Cancers. Pilot Study.

Bital Savir-Baruch1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2018年11月14日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
4 期
发起方
入组人数
30
试验地点
1
主要终点
18F-Fluciclovine uptake in gynecologic neoplasms

研究概览

简要总结

An important part of staging and deciding the method of treatment is knowing areas of how cancer is involved. Diagnostic imaging is often used to determine the location of the cancer using techniques like nuclear medicine, MRI (magnetic resonance imaging), CT (computerized tomography), and ultrasound. Each technique looks for cancer in different ways and are often used together to make a better determination of the extent of disease.

One of the techniques used in cancer imaging is PET/CT. This technique combines a nuclear medicine study (PET or positron emission tomography) with CT performing both scans at the same time. PET/CT most commonly uses a radioactive sugar (FDG or fluorodeoxyglucose) to detect the cancer. The problem with FDG is that it is excreted by the kidneys and collected in the bladder. Even though the bladder is emptied prior to the scan, the FDG activity present there may interfere with the detection of small areas of cancer involvement in lymph nodes or adjacent areas. It is because of this that PET/CT using FDG is infrequently used in gynecological cancers.

This purpose of this study is to evaluate if 18F-fluciclovine can be used to help determine the extent of gynecological cancers. 18F-fluciclovine (also known as AXUMIN) is a radioactive tracer which has been approved by the FDAFood and Drug Administration (FDA) for use in patients with prostate cancer. 18F-fluciclovine has much less excretion through the kidneys which improves the PET/CT imaging of the pelvis.

研究设计

研究类型
Interventional
分配方式
Na
干预模型
Single Group
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • GYN cancer (ovarian, endometrial, or cervical) was biopsy-proven and/or schedule for subsequent surgery based on clinical presentation (imaging, markers)
  • Age ≥ 18 years.
  • Can tolerate 18F-fluciclovine PET/CT exam (can lie on her back for the duration of the scan).
  • Ability to understand and the willingness to sign a written informed consent.

排除标准

  • Ongoing systemic therapy for cancer
  • Systemic therapy for cancer in the past 3 months
  • Inability to tolerate 18F-fluciclovine PET/CT exam
  • Pregnant or lactating women

研究组 & 干预措施

18F-Fluciclovine

Experimental

干预措施: Fluciclovine F18 (Drug)

结局指标

主要结局

18F-Fluciclovine uptake in gynecologic neoplasms

时间窗: Day 30

PET/CT imaging

次要结局

未报告次要终点

研究者

发起方
Bital Savir-Baruch
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Bital Savir-Baruch

Nuclear Medicine Assistant Professor

Loyola University

研究点 (1)

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