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Clinical Trials/NCT02110277
NCT02110277
Terminated
Not Applicable

Photoacoustic Imaging of the Ovary

UConn Health1 site in 1 country2 target enrollmentMarch 2014
ConditionsOvarian Cancer

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Ovarian Cancer
Sponsor
UConn Health
Enrollment
2
Locations
1
Primary Endpoint
To Measure Photoacoustic Imaging (PAI)/Ultrasound Signature From Ovaries Prior to Surgery Using the Ratio of Deoxy/Oxy Hb
Status
Terminated
Last Updated
8 years ago

Overview

Brief Summary

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.

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.

Registry
clinicaltrials.gov
Start Date
March 2014
End Date
May 2016
Last Updated
8 years ago
Study Type
Interventional
Study Design
Single Group
Sex
Female

Investigators

Sponsor
UConn Health
Responsible Party
Principal Investigator
Principal Investigator

Molly Brewer

Professor, Obstetrics and Gynecology

UConn Health

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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.

Secondary Outcomes

  • Pathologic Diagnosis and in Vivo Imaging(5 years)

Study Sites (1)

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