Photoacoustic Imaging in Detecting Ovarian or Fallopian Tube Cancer

NCT ID: NCT02530606

Last Updated: 2018-11-28

Basic Information

• Recruitment Status: WITHDRAWN
• Clinical Phase: NA
• Study Classification: INTERVENTIONAL
• Study Start Date: 2016-09-30
• Study Completion Date: 2018-11-30

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.

Conditions

Fallopian Tube Carcinoma; Ovarian Carcinoma

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Diagnostic (PAI)

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

Group Type: EXPERIMENTAL

Photoacoustic Imaging

Intervention Type: PROCEDURE

Undergo PAI

Interventions

Photoacoustic Imaging

Undergo PAI

Intervention Type: PROCEDURE

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Stanford University

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Sanjiv Gambhir

Role: PRINCIPAL_INVESTIGATOR

Stanford Cancer Institute

Locations

Stanford University, School of Medicine

Palo Alto, California, United States

Countries

United States

Other Identifiers

NCI-2015-01284

Identifier Type: REGISTRY

Identifier Source: secondary_id

348

Identifier Type: -

Identifier Source: secondary_id

31295

Identifier Type: OTHER

Identifier Source: secondary_id

GYNOPF0014

Identifier Type: -

Identifier Source: org_study_id