Photoacoustic Imaging in Detecting Ovarian or Fallopian Tube Cancer

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

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.

Study Overview

• Status: Withdrawn
• Conditions: Fallopian Tube Carcinoma; Ovarian Carcinoma
• Intervention / Treatment: Procedure: Photoacoustic Imaging

Detailed 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.

• Study Type: Interventional
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Palo Alto, California, United States, 94304
      • Stanford University, School of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Diagnostic (PAI); Patients undergo PAI over 15-30 minutes prior to the ovarian excision.	Procedure: Photoacoustic Imaging; Undergo PAI

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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)
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)
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)
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)
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)
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)
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)

Collaborators and Investigators

• Sponsor: Stanford University
• Investigators: Principal Investigator: Sanjiv Gambhir, Stanford Cancer Institute

Study record dates

Study Major Dates

• Study Start: September 1, 2016
• Primary Completion (Anticipated): September 1, 2017
• Study Completion (Actual): November 1, 2018

Study Registration Dates

• First Submitted: August 19, 2015
• First Submitted That Met QC Criteria: August 19, 2015
• First Posted (Estimate): August 21, 2015

Study Record Updates

• Last Update Posted (Actual): November 28, 2018
• Last Update Submitted That Met QC Criteria: November 26, 2018
• Last Verified: November 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Carcinoma
• Other Study ID Numbers: GYNOPF0014; NCI-2015-01284 (Registry Identifier: CTRP (Clinical Trial Reporting Program)); 348; 31295 (Other Identifier: Stanford IRB)