Photoacoustic Imaging in Detecting Ovarian or Fallopian Tube Cancer

Brief Title

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

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.

Study Type

Interventional

Primary Outcome

Depth of lesion from skin surface as measured by ultrasound (US)

Condition

Fallopian Tube Carcinoma

Intervention

Photoacoustic Imaging

Study Arms / Comparison Groups

 Diagnostic (PAI)

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

Publications

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status

Procedure

Estimated Enrollment

Start Date

September 2016

Completion Date

November 2018

Primary Completion Date

September 2017

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

Gender

Female

Ages

18 Years - 80 Years

Accepts Healthy Volunteers

No

Contacts

Sanjiv Gambhir, ,

Location Countries

United States

Location Countries

United States

Administrative Informations

NCT ID

NCT02530606

Organization ID

GYNOPF0014

Secondary IDs

NCI-2015-01284

Responsible Party

Sponsor

Study Sponsor

Stanford University

Study Sponsor

Sanjiv Gambhir, Principal Investigator, Stanford Cancer Institute

Verification Date

November 2018