Transvaginal Ultrasound and Photoacoustic Imaging of the Ovaries and the Fallopian Tubes: A Clinical Feasibility Study
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 试验地点
- 2
- 主要终点
- PAI signal intensity measured as signal-to-noise ratio (SNR) in dB in region of interest (ROI)
研究概览
简要总结
This pilot clinical trial studies how well photoacoustic imaging works in detecting ovarian or fallopian tube cancer. Photoacoustic imaging is an imaging method that uses lasers to light up tissue, and then converts the light information into ultrasound images. Photoacoustic imaging can provide images of the structure of tissues, as well as their function and the levels of molecules, such as the flow of blood in blood vessels and the level of oxygen in the blood. Photoacoustic imaging may help doctors determine whether a mass is benign (non-cancerous) or cancerous based on the molecular differences between cancer and normal tissue. It may be more accurate and less expensive than other imaging methods, and does not expose patients to radiation.
详细描述
PRIMARY OBJECTIVES:
I. To assess the performance of photoacoustic imaging (PAI) in detection of ovarian cancer in a clinical setting and to help improve the design of the next generation hand held PAI probe.
SECONDARY OBJECTIVES:
I. To evaluate vasculature and oxygen saturation in lesions based on PAI-measurements.
OUTLINE:
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 80 Years（Adult, Older Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Patients must be undergoing ovarian resection
- •Ability to understand and the willingness to sign a written informed consent document
排除标准
- •Patients who have had primary surgical excision
- •Pregnant or lactating women
研究组 & 干预措施
Diagnostic (PAI)
Patients undergo PAI over 15-30 minutes prior to the ovarian excision.
干预措施: Photoacoustic Imaging (Procedure)
结局指标
主要结局
PAI signal intensity measured as signal-to-noise ratio (SNR) in dB in region of interest (ROI)
时间窗: Post-surgery processing (up to 1 year)
Descriptive statistics (proportions, means) will be used to summarize PAI signal intensity. The distribution of signal intensity on PAI, HbT, and SO2 will be summarized separately by lesion depth, size and status using means and will be graphed as boxplots with a P value of the corresponding Kendall correlation to aid in interpretation. The area under the ROC curve will be computed along with a 95% confidence interval based on the .632 bootstrap estimated error rate.
Time span for PAI examination
时间窗: Baseline (at the time of surgery)
Descriptive statistics (proportions, means) will be used to summarize time span for PAI examination. The distribution of signal intensity on PAI, total hemoglobin concentration (HbT), and oxygen saturation (SO2) will be summarized separately by lesion depth, size and status using means and will be graphed as boxplots with a P value of the corresponding Kendall correlation to aid in interpretation. The area under the receiver operating characteristic (ROC) curve will be computed along with a 95% confidence interval based on the .632 bootstrap estimated error rate.
Depth of lesion from skin surface as measured by ultrasound (US)
时间窗: Baseline (at the time of surgery)
Descriptive statistics (proportions, means) will be used to summarize depth of lesion. The distribution of signal intensity on PAI, HbT, and SO2 will be summarized separately by lesion depth, size and status using means and will be graphed as boxplots with a P value of the corresponding Kendall correlation to aid in interpretation. The area under the ROC curve will be computed along with a 95% confidence interval based on the .632 bootstrap estimated error rate.
Percent SO2 in ROI
时间窗: Post-surgery processing (up to 1 year)
Descriptive statistics (proportions, means) will be used to summarize percent SO2 in ROI. The distribution of signal intensity on PAI, HbT, and SO2 will be summarized separately by lesion depth, size and status using means and will be graphed as boxplots with a P value of the corresponding Kendall correlation to aid in interpretation. The area under the ROC curve will be computed along with a 95% confidence interval based on the .632 bootstrap estimated error rate.
Lesion total hemoglobin per PAI
时间窗: Post-surgery processing (up to 1 year)
Descriptive statistics (proportions, means) will be used to summarize lesion total hemoglobin. The distribution of signal intensity on PAI, HbT, and SO2 will be summarized separately by lesion depth, size and status using means and will be graphed as boxplots with a P value of the corresponding Kendall correlation to aid in interpretation. The area under the ROC curve will be computed along with a 95% confidence interval based on the .632 bootstrap estimated error rate.
Size of lesion as measured by US
时间窗: Baseline (at the time of surgery)
Descriptive statistics (proportions, means) will be used to summarize size of lesion. The distribution of signal intensity on PAI, HbT, and SO2 will be summarized separately by lesion depth, size and status using means and will be graphed as boxplots with a P value of the corresponding Kendall correlation to aid in interpretation. The area under the ROC curve will be computed along with a 95% confidence interval based on the .632 bootstrap estimated error rate.
Visibility/quality rating of PAI-image as measured by 5-level scale: not visible, barely visible, fair (or moderately) visible, visible, and clearly visible
时间窗: Baseline (at the time of surgery)
Descriptive statistics (proportions, means) will be used to summarize visibility/quality rating of PAI. The distribution of signal intensity on PAI, HbT, and SO2 will be summarized separately by lesion depth, size and status using means and will be graphed as boxplots with a P value of the corresponding Kendall correlation to aid in interpretation. The area under the ROC curve will be computed along with a 95% confidence interval based on the .632 bootstrap estimated error rate.
次要结局
未报告次要终点