Trials / Terminated
TerminatedNCT02110277
Photoacoustic Imaging of the Ovary
- Status
- Terminated
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 2 (actual)
- Sponsor
- UConn Health · Academic / Other
- Sex
- Female
- Age
- 21 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| 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. |
Timeline
- Start date
- 2014-03-01
- Primary completion
- 2016-05-01
- Completion
- 2016-05-01
- First posted
- 2014-04-10
- Last updated
- 2018-03-13
- Results posted
- 2018-03-13
Locations
1 site across 1 country: United States
Source: ClinicalTrials.gov record NCT02110277. Inclusion in this directory is not an endorsement.