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临床试验/NCT03931655
NCT03931655终止不适用

A Preliminary Study of Photoacoustic Imaging to Detect Micrometastases in the Lymph Nodes of Breast Cancer Patients

Geoff Luke1 个研究点 分布在 1 个国家目标入组 1 人开始时间: 2019年11月1日最近更新:
适应症

试验速览

阶段
不适用
状态
终止
发起方
入组人数
1
试验地点
1
主要终点
Spectroscopic photoacoustic image acquisition feasibility

研究概览

简要总结

In this spectroscopic photoacoustic imaging study, the investigators will acquire images (only) to:

  1. determine if spectroscopic photoacoustic imaging can acquire high fidelity images in a clinical setting,
  2. discover if blood oxygen saturation changes are observable in breast cancer patients during early stages of metastatic invasion, and
  3. compare the sensitivity and specificity of photoacoustic imaging with ultrasound imaging for the detection of lymph node metastases.

The results from imaging will not be used in any decision making process. This study is solely used to test the photoacoustic imaging device and evaluate it against the current standard of care. The device is completely noninvasive and uses only safe levels of energy as determined by the American National Standards Institute (ANSI) and the FDA. The device does not pose a serious to the health, safety, or welfare of the patient.

详细描述

The study is centered on determining whether photoacoustic imaging of blood oxygen saturation can detect lymph node metastases.

Patients who are returning for an ultrasound exam after detection of a suspicious node via magnetic resonance imaging will be enrolled in the study.

Enrolled patients will receive a clinical ultrasound exam, as is the current standard of care. Suspicious nodes will be identified and imaged with combined ultrasound and spectroscopic photoacoustic imaging. Measurements will be acquired with three to five replicates with slightly modified transducer positioning to measure system and intranodal variance of the measurements. One to five contralateral axillary lymph nodes will be imaged to serve as a control and to determine patient-to-patient variability in lymph node saturated oxygen. The distance from the skin to the lymph node will also be measured with ultrasound imaging for each node.

If the ultrasound imaging identifies a suspicious node, patients will undergo ultrasound guided biopsy to confirm the true metastatic state of the nodes. Suspicious nodes will be clipped to facilitate identification at the time of axillary node dissection. During the sentinel node procedure, investigators will use intraoperative photoacoustic imaging to measure the blood oxygenation in the sentinel lymph node immediately prior to its removal. Histology will be performed on all biopsy samples and excised nodes to determine the true metastatic state of the node(s).

研究设计

研究类型
Observational
观察模型
Case Only
时间视角
Prospective

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

  • 未提供

排除标准

  • 未提供

结局指标

主要结局

Spectroscopic photoacoustic image acquisition feasibility

时间窗: Through study completion, an average of 12 weeks

Determine the feasibility of using spectroscopic photoacoustic imaging to determine the metastatic state of lymph nodes prior to surgery/biopsy by measuring changes in blood oxygen saturation.

次要结局

  • Spectroscopic photoacoustic imaging device comparison(Day 1, up to 12 weeks after imaging)
  • Spectroscopic photoacoustic image depth(Day 1, up to 12 weeks after imaging)

研究者

发起方
Geoff Luke
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Geoff Luke

Co-Investigator and Regulatory Sponsor

Dartmouth-Hitchcock Medical Center

研究点 (1)

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