Have you or your loved ones been diagnosed with ovarian cancer?

You may be eligible to participate in a ovarian cancer clinical trial.

Have you or your loved ones been diagnosed with ovarian cancer? You may be eligible to participate in a ovarian cancer clinical trial.

What is a clinical trial? Is participating in a clinical trial right for you? Learn more

Ovarian Cancer Clinical Trial in Farmington CT

NCT02110277 | Interventional

Have you or your loved ones been diagnosed with ovarian cancer?

You may be eligible to participate in a ovarian cancer clinical trial.

Have you or your loved ones been diagnosed with ovarian cancer? You may be eligible to participate in a ovarian cancer clinical trial.

Terminated

Female

21 Years +

This study is looking to recruit 40 Participants

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.

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Details for the study

Brief Title

Photoacoustic Imaging of the Ovary

Official Title

Photoacoustic Imaging of the Ovary

Brief Summary

The purpose of this study is to develop technology to image the ovaries in order to better<br /> evaluate ovarian disease and to study how these experimental imaging techniques might work<br /> 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.

Treatments and/or Procedures

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.

Outcome Measures

Outcome measures are the tests that investigators perform to prove whether or not a treatment being tested in a clinical trial is having any effect.

Primary

To Measure Photoacoustic Imaging (PAI)/Ultrasound Signature From Ovaries Prior to Surgery Using the Ratio of Deoxy/Oxy Hb

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

Pathologic Diagnosis and in Vivo Imaging

To characterize the tissue images with pathologic diagnosis and to refine the system based on the characteristic features of in vivo imaging.

5 years

Study 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.