Photoacoustic Imaging of the Ovary

March 8, 2018 updated by: Molly Brewer, UConn Health
The purpose of this study is to develop technology to image the ovaries in order to better evaluate ovarian disease and to study how these experimental imaging techniques might work together or separately to improve our ability to detect ovarian cancer.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Detailed Description

Epithelial ovarian cancer causes the highest mortality of any of the gynecologic cancers although it is the second most common gynecologic malignancy. Ovarian cancer is not usually detected earlier than Stage III or IV because it is usually asymptomatic; yet survival is high with early stage disease. In addition, women with a pelvic mass noted on ultrasound that undergo oophorectomy have only a 1-3% risk of malignancy and thus 97-99% will be overtreated because of our inability to reliably differentiate benign from malignant masses with ultrasound. BRCA1 testing and family history will identify certain high-risk individuals who have a higher risk of malignancy and need a modality that will be more reliable in detecting early cancers to provide more accurate surveillance.We are developing a new transvaginal imaging device optimized for ovarian cancer detection, diagnosis and validated from ex vivo and in vivo clinical studies. This automated system may provide an early diagnostic tool for ovarian cancer in the future.

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Connecticut
      • Farmington, Connecticut, United States, 06032
        • UConn Health

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • All patients, twenty one years or older, referred to the University of Connecticut for conditions necessitating oophorectomy.
  • Patients cannot be pregnant or wish to become pregnant.
  • Willingness to participate in the study.

Exclusion Criteria:

  • All Subjects who fail to meet the inclusion criteria are ineligible for the study.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: PAI/ultrasound Diagnostic Group
These patients will include women who are at risk for ovarian cancer and wish to undergo prophylactic oophorectomy, or who have an ovarian mass suggestive of a malignancy and are counseled to undergo oophorectomy.
Device: PAI/ultrasound Diagnostic Group
These patients will include women who are at risk for ovarian cancer and wish to undergo prophylactic oophorectomy, or who have an ovarian mass suggestive of a malignancy and are counseled to undergo oophorectomy.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
To Measure Photoacoustic Imaging (PAI)/Ultrasound Signature From Ovaries Prior to Surgery Using the Ratio of Deoxy/Oxy Hb
Time Frame: 5 years
To develop a method of analyzing PAI ovarian tissue images measuring oxy and deoxy hemoglobin as well as the ratio of deoxy/oxy Hb to recognize the presence of ovarian abnormalities and compare changes seen with ultrasound to changes seen with PAI.
5 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Pathologic Diagnosis and in Vivo Imaging
Time Frame: 5 years
To characterize the tissue images with pathologic diagnosis and to refine the system based on the characteristic features of in vivo imaging.
5 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

UConn Health

Collaborators

National Cancer Institute (NCI)

Investigators

  • Principal Investigator: Molly Brewer, MD, UConn Health

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

March 1, 2014

Primary Completion (Actual)

May 1, 2016

Study Completion (Actual)

May 1, 2016

Study Registration Dates

First Submitted

April 7, 2014

First Submitted That Met QC Criteria

April 7, 2014

First Posted (Estimate)

April 10, 2014

Study Record Updates

Last Update Posted (Actual)

March 13, 2018

Last Update Submitted That Met QC Criteria

March 8, 2018

Last Verified

November 1, 2017

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 14-139S-3
  • R01CA151570 (U.S. NIH Grant/Contract)

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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