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临床试验/NCT01659645
NCT01659645已完成早期 1 期

Amino Acid Transport Imaging of Breast Carcinoma Via Anti-3-[18F]FACBC PET-CT: A Pilot Study

Emory University1 个研究点 分布在 1 个国家目标入组 12 人开始时间: 2012年8月最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
已完成
入组人数
12
试验地点
1
主要终点
Presence of FACBC radiotracer in breast carcinoma on FACBC PET scan

研究概览

简要总结

Breast carcinoma is the most frequent cancer in women, affecting an estimated 207,090 in 2010 leading to 39,840 cancer related deaths.

Fludeoxyglucose F 18 Injection (FDG) Positron Emission Tomography, (PET) or PET-CT has become the a standard method for isolating the tumor. However, FDG is insensitive in small breast tumors and certain histologic types such as lobular, certain types of breast carcinoma. In addition, FDG uptake can be nonspecific since inflammatory some benign lesions may also evidence have accumulation of this radiotracer. Hence there is a need for a tracer/imaging tool that increases the ability to characterize detect breast carcinoma and to detect locoregional spread, as well as monitor therapeutic treatment response.

anti-3-[18F]. anti-1-amino-3-[18F]fluorocyclobutyl-1-carboxylic acid (FACBC) is an amino acid based PET radiotracer which has shown utility in detecting a variety of tumors. In cell culture experiments,FACBC has shown uptake in the breast tumor cell line.

The primary aim of this study is to determine if FACBC PET-CT demonstrates uptake within breast carcinoma (primary site and/or locoregional lymph nodes) and to study uptake kinetics via time-activity curves from dynamic imaging characteristics. The investigators will enroll 12 patients who have a breast mass or masses and/or lymph nodes naïve to therapy about to undergo biopsy or post-biopsy pre-therapy. All patients will undergo standard of care imaging as appropriate such as mammography, ultrasound, MR, and/or FDG PET-CT scanning. The investigators will then compare findings to determine if this radiotracer is worthy of further study in a more comprehensive experiment.

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 85 Years(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • Patients must be 18 years of age or older.
  • Patients will have a breast mass and/or lymph nodes naïve to therapy about to undergo biopsy or post-biopsy pre-therapy. Patients with known or suspected recurrent disease will be eligible for this protocol.
  • Ability to lie still for PET scanning
  • Patients must be able to provide written informed consent

排除标准

  • Age less than
  • Inability to lie still for PET scanning.
  • Cannot provide written informed consent.
  • Current therapy for breast carcinoma.
  • Positive serum or urine pregnancy test within 24 hours of study.

研究组 & 干预措施

FACBC

Experimental

干预措施: FACBC (Drug)

结局指标

主要结局

Presence of FACBC radiotracer in breast carcinoma on FACBC PET scan

时间窗: Outcomes will be assessed at the end of one year.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

David M. Schuster, MD

Sponsor-Investigator

Emory University

研究点 (1)

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