Photoacoustic Imaging in Detecting Ovarian or Fallopian Tube Cancer

Ovarian Carcinoma Clinical Trial

Official title:

Transvaginal Ultrasound and Photoacoustic Imaging of the Ovaries and the Fallopian Tubes: A Clinical Feasibility Study

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT02530606
• Other study ID #: GYNOPF0014
• Secondary ID: NCI-2015-0128434
• Status: Withdrawn
• Phase: N/A
• Start date: September 2016
• Est. completion date: November 2018

Study information

• Verified date: November 2018
• Source: Stanford University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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:

Patients undergo PAI over 15-30 minutes prior to the ovarian excision.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2018
• Est. primary completion date: September 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

Inclusion Criteria:

• Patients must be undergoing ovarian resection

• Ability to understand and the willingness to sign a written informed consent document

Exclusion Criteria:

• Patients who have had primary surgical excision

• Pregnant or lactating women

Related Conditions & MeSH terms

• Carcinoma
• Fallopian Tube Carcinoma
• Fallopian Tube Neoplasms
• Ovarian Carcinoma
• Ovarian Neoplasms

Intervention

Procedure:
• Photoacoustic Imaging
Undergo PAI

Locations

Country	Name	City	State
United States	Stanford University, School of Medicine	Palo Alto	California

Sponsors (1)

Lead Sponsor	Collaborator
Stanford University

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Depth of lesion from skin surface as measured by ultrasound (US)	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.	Baseline (at the time of surgery)
Primary	Lesion total hemoglobin per PAI	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.	Post-surgery processing (up to 1 year)
Primary	PAI signal intensity measured as signal-to-noise ratio (SNR) in dB in region of interest (ROI)	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.	Post-surgery processing (up to 1 year)
Primary	Percent SO2 in ROI	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.	Post-surgery processing (up to 1 year)
Primary	Size of lesion as measured by US	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.	Baseline (at the time of surgery)
Primary	Time span for PAI examination	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.	Baseline (at the time of surgery)
Primary	Visibility/quality rating of PAI-image as measured by 5-level scale: not visible, barely visible, fair (or moderately) visible, visible, and clearly visible	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.	Baseline (at the time of surgery)