Ovarian Cancer Clinical Trial

Transvaginal Ultrasound and Photoacoustic Imaging of Ovary

Summary

This study is being conducted to validate if photoacoustic imaging potentially reduces benign surgeries without compromising cancer detection sensitivity. The study will also explore whether using the photoacoustic imaging/ultrasound technique has any potential with early ovarian cancer detection in a group of high risk patients.

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Full Description

In primary and secondary objectives, the investigators will consent patients who are at risk for ovarian cancer, or who have an ovarian mass possibly suggestive of a malignancy and are counseled to undergo oophorectomy. Patients will be identified by the GYN physicians and consented by the study coordinator prior to the date of the scheduled surgical procedure.

In exploratory objectives, the investigators will consent patients who are at risk for ovarian cancer and wish to be followed before making decision to undergo prophylactic oophorectomy. Patients will be identified based on the eligibility criteria by the physicians and consented by the study coordinator prior to the follow up studies.

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Eligibility Criteria

Inclusion Criteria for Primary and Secondary Outcome Measures

All patients, 18 years or older, referred to the Washington University School of Medicine for conditions necessitating surgery to include at least a unilateral oophorectomy.
Willingness to participate in the study and able to provide informed consent.

Inclusion Criteria for Exploratory Outcome Measures

At least 18 years of age
Referred to the Washington University School of Medicine for conditions necessitating surgery to include at least a unilateral oophorectomy, an ovarian cystectomy, or a unilateral or bilateral salpingectomy .
Willing to be followed for one to 4.5 years prior to making the decision to undergo prophylactic oophorectomy.
Documented deleterious mutation in one of the following ovarian cancer genes: BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, PMS2, or EPCAM.

Exclusion Criteria:

Male
Younger than 18 years of age

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

310

Study ID:

NCT04178018

Recruitment Status:

Recruiting

Sponsor:

Washington University School of Medicine

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There is 1 Location for this study

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Washington University School of Medicine
Saint Louis Missouri, 63110, United States More Info
Cary L Siegel, M.D.
Contact
314-362-2928
[email protected]
Cary L Siegel, M.D.
Principal Investigator
Matthew Powell, M.D.
Sub-Investigator
Andrea Hagemann, M.D.
Sub-Investigator
William Middleton, M.D.
Sub-Investigator
David Mutch, M.D.
Sub-Investigator
Malak Itani, M.D.
Sub-Investigator
Anup Shetty, M.D.
Sub-Investigator
Valerie Ratts, M.D.
Sub-Investigator
Lindsay K Kuroki, M.D.
Sub-Investigator
Carolyn McCourt, M.D.
Sub-Investigator
Katherine Fuh, M.D., Ph.D.
Sub-Investigator
Ian S Hagemann, M.D., Ph.D.
Sub-Investigator
Esther Lu, Ph.D.
Sub-Investigator
Quing Zhu, Ph.D.
Sub-Investigator

How clear is this clinincal trial information?

Study is for people with:

Ovarian Cancer

Estimated Enrollment:

310

Study ID:

NCT04178018

Recruitment Status:

Recruiting

Sponsor:


Washington University School of Medicine

How clear is this clinincal trial information?

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