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临床试验/NCT06220214
NCT06220214招募中早期 1 期

Contrast Enhanced Digital Mammography for Predicting Pathologic Complete Response After Neoadjuvant Chemotherapy

Alison Stopeck1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年3月6日最近更新:
适应症
干预措施
相关药物

试验速览

阶段
早期 1 期
状态
招募中
发起方
入组人数
30
试验地点
1
主要终点
Accuracy of (CEDM+CEDBT) to predict NAC treatment effects

研究概览

简要总结

The purpose of this study is to compare a special type of mammogram that uses a contrast agent called contrast-enhanced digital mammography with contrast-enhanced digital breast tomosynthesis (CEDM+CEDBT), with breast magnetic resonance imaging imaging (MRI) for predicting the effect of neoadjuvant chemotherapy on pathologic complete response rates. The device used to obtain CEDM+CEDBT images is called Siemens MAMMOMAT. This device produces two-dimensional (2D) images, as in a normal mammogram, but also collects additional images for digital breast tomosynthesis (DBT), which produces a three-dimensional (3D) image of the breast in the form of image slices. DBT allows the radiologist to "see through" the breast tissue for better detection and localization of breast cancer. By looking at both the CEDM images and the CEDBT images, a radiologist may be able to better detect residual breast cancer in a more cost-effective manner.

Participation may last up to 18 weeks.

Study procedures for this research are:

  • Undergoing 1-2 mammograms during and/or after your chemotherapy, but before primary breast surgery.
  • Before each mammogram, have a radiology technician inject a liquid contrast agent by inserting a needle into a vein. The chemotherapy port cannot be used to receive the contrast agent
  • Let the research team record information from your medical record related to your condition and the treatment you receive.
  • Give permission to collect leftover tissue from your diagnostic biopsy and breast surgery.

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

  • Diagnosis with either type of invasive locally advanced breast cancer regardless of hormone receptor or Her2 status
  • Plan to receive at least 4 cycles of neoadjuvant chemotherapy ahead of definitive surgery

排除标准

  • Pregnancy
  • Allergy/sensitivity to contrast agent
  • Decreased kidney function

研究组 & 干预措施

CEDM + CEDBT

Experimental

Participants undergo CEDM + CEDBT imaging after every 4-6 cycles of neoadjuvant chemotherapy prior to surgery (imaging may occur up to 2 times)

干预措施: CEDM (Diagnostic Test)

CEDM + CEDBT

Experimental

Participants undergo CEDM + CEDBT imaging after every 4-6 cycles of neoadjuvant chemotherapy prior to surgery (imaging may occur up to 2 times)

干预措施: CEDBT (Diagnostic Test)

CEDM + CEDBT

Experimental

Participants undergo CEDM + CEDBT imaging after every 4-6 cycles of neoadjuvant chemotherapy prior to surgery (imaging may occur up to 2 times)

干预措施: Omnipaque 350mgI/mL Solution for Injection (Drug)

结局指标

主要结局

Accuracy of (CEDM+CEDBT) to predict NAC treatment effects

时间窗: Immediately after definitive breast surgery, up to 24 weeks

The ability of CEDM + CEDBT to predict pathologic complete response to neoadjuvant chemotherapy, determined by histopathology evaluation of the resected breast

次要结局

  • Accuracy of (CEDM+CEDBT) to detect residual tumor compared with standard of care MRI(Immediately before definitive breast surgery)

研究者

发起方
Alison Stopeck
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Alison Stopeck

Professor of Medicine

Stony Brook University

研究点 (1)

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