Photoacoustic Imaging of the Ovary
Primary Purpose
Ovarian Cancer
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
PAI/ultrasound Diagnostic Group
Sponsored by
About this trial
This is an interventional diagnostic trial for Ovarian Cancer focused on measuring Ovarian Cancer, Epithelial ovarian cancer
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.
Sites / Locations
- UConn Health
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
PAI/ultrasound Diagnostic Group
Arm Description
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.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
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.
Full Information
NCT ID
NCT02110277
First Posted
April 7, 2014
Last Updated
March 8, 2018
Sponsor
UConn Health
Collaborators
National Cancer Institute (NCI)
1. Study Identification
Unique Protocol Identification Number
NCT02110277
Brief Title
Photoacoustic Imaging of the Ovary
Official Title
Photoacoustic Imaging of the Ovary
Study Type
Interventional
2. Study Status
Record Verification Date
November 2017
Overall Recruitment Status
Terminated
Why Stopped
Dr Zhu, collaborator and the inventor of the photoacoustic system, is leaving the institution and it is not feasible to conduct the study without the machine.
Study Start Date
March 2014 (undefined)
Primary Completion Date
May 2016 (Actual)
Study Completion Date
May 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
UConn Health
Collaborators
National Cancer Institute (NCI)
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Ovarian Cancer
Keywords
Ovarian Cancer, Epithelial ovarian cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
PAI/ultrasound Diagnostic Group
Arm Type
Experimental
Arm Description
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.
Intervention Type
Device
Intervention Name(s)
PAI/ultrasound Diagnostic Group
Intervention Description
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.
Primary Outcome Measure Information:
Title
To Measure Photoacoustic Imaging (PAI)/Ultrasound Signature From Ovaries Prior to Surgery Using the Ratio of Deoxy/Oxy Hb
Description
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.
Time Frame
5 years
Secondary Outcome Measure Information:
Title
Pathologic Diagnosis and in Vivo Imaging
Description
To characterize the tissue images with pathologic diagnosis and to refine the system based on the characteristic features of in vivo imaging.
Time Frame
5 years
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
21 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Molly Brewer, MD
Organizational Affiliation
UConn Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
UConn Health
City
Farmington
State/Province
Connecticut
ZIP/Postal Code
06032
Country
United States
12. IPD Sharing Statement
Learn more about this trial
Photoacoustic Imaging of the Ovary
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