Ovarian Cancer
Conditions
Keywords
Ovarian Cancer, Epithelial ovarian cancer
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.
Interventions
DEVICEPAI/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.
Sponsors
National Cancer Institute (NCI)
UConn Health
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
21 Years to No maximum
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| To Measure Photoacoustic Imaging (PAI)/Ultrasound Signature From Ovaries Prior to Surgery Using the Ratio of Deoxy/Oxy Hb | 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
| Measure | Time frame | Description |
|---|---|---|
| Pathologic Diagnosis and in Vivo Imaging | 5 years | To characterize the tissue images with pathologic diagnosis and to refine the system based on the characteristic features of in vivo imaging. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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.
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. | 0 |
| Total | 0 |
Baseline characteristics
| Characteristic | — |
|---|---|
| Region of Enrollment United States | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 0 |
| other Total, other adverse events | 0 / 0 |
| serious Total, serious adverse events | 0 / 0 |
Outcome results
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.
Time frame: 5 years
Population: Study prematurely terminated and no results analyzed.
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.
Time frame: 5 years
Population: 0 participants analyzed since study was terminated prematurely.