Photoacoustic Imaging of the Ovary

Ovarian Cancer Clinical Trial

Official title:

Photoacoustic Imaging of the Ovary

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02110277
• Other study ID #: 14-139S-3
• Secondary ID: R01CA151570
• Status: Terminated
• Phase: N/A
• First received: April 7, 2014
• Last updated: March 8, 2018
• Start date: March 2014
• Est. completion date: May 2016

Study information

• Verified date: November 2017
• Source: UConn Health
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: May 2016
• Est. primary completion date: May 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 21 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Ovarian Cancer
• Ovarian Neoplasms

Intervention

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.

Locations

Country	Name	City	State
United States	UConn Health	Farmington	Connecticut

Sponsors (2)

Lead Sponsor	Collaborator
UConn Health	National Cancer Institute (NCI)

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
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