Clinical trial NCT02530606: Photoacoustic Imaging in Detecting Ovarian or Fallopian Tube Cancer
Official title: Transvaginal Ultrasound and Photoacoustic Imaging of the Ovaries and the Fallopian Tubes: A Clinical Feasibility Study
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: NA
Conditions: Fallopian Tube Carcinoma
Ovarian Carcinoma
Lead sponsor: Stanford University
Sponsor class: OTHER
First posted: 2015-08-21
Enrollment: 0
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: DIAGNOSTIC

Brief 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.

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.

Eligibility criteria: 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

Primary outcomes:
measure: Depth of lesion from skin surface as measured by ultrasound (US)
timeFrame: Baseline (at the time of surgery)
measure: Lesion total hemoglobin per PAI
timeFrame: Post-surgery processing (up to 1 year)
measure: PAI signal intensity measured as signal-to-noise ratio (SNR) in dB in region of interest (ROI)
timeFrame: Post-surgery processing (up to 1 year)
measure: Percent SO2 in ROI
timeFrame: Post-surgery processing (up to 1 year)
measure: Size of lesion as measured by US
timeFrame: Baseline (at the time of surgery)
measure: Time span for PAI examination
timeFrame: Baseline (at the time of surgery)
measure: Visibility/quality rating of PAI-image as measured by 5-level scale: not visible, barely visible, fair (or moderately) visible, visible, and clearly visible
timeFrame: Baseline (at the time of surgery)
Secondary outcomes:
Other outcomes:
Locations:
city: Palo Alto
country: United States
facility: Stanford University, School of Medicine
state: California
Study officials:
affiliation: Stanford Cancer Institute
name: Sanjiv Gambhir
role: PRINCIPAL_INVESTIGATOR
References: