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| ID | Type | Description | Link |
|---|---|---|---|
| 1R01CA237664-01A1 | U.S. NIH Grant/Contract | View source |
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Loss of space for imaging
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| Name | Class |
|---|---|
| National Cancer Institute (NCI) | NIH |
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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.
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Transvaginal photoacoustic imaging/ultrasound | Experimental |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Photoacoustic imaging | Device | -Emerging technique in which a short-pulsed laser beam penetrates diffusively into a tissue sample |
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| Measure | Description | Time Frame |
|---|---|---|
| Assess the impact of co-registered PAI/US on the potential reduction of benign surgeries as measured by the area under receiver characteristic curve (AUC) | The anticipated improvement of diagnostic accuracy on reduction of surgeries of benign ovaries will be from current practice of AUC=55% to AUC=78%. | At the time of surgery (estimated to be 2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| False negative rate of conventional imaging compared to conventional imaging & PAI/US as measured by sensitivity of cancer detection | The anticipated improvement of cancer detection accuracy will be from current practice of 80% to 94%. | At the time of surgery (estimated to be 2 weeks) |
| Measure | Description | Time Frame |
|---|---|---|
| Determine if co-registered PAI/US can be used as a sensitive and specific screening tool for early detection of malignant neoangiogenesis within a group of high-risk women | The investigators hope to improve current practice by detecting early cancers from this group of high-risk women | Through completion of follow-up (estimated to be 4.5 years) |
Inclusion Criteria for Primary and Secondary Outcome Measures
Inclusion Criteria for Exploratory Outcome Measures
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Cary L Siegel, M.D. | Washington University School of Medicine | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Washington University School of Medicine | St Louis | Missouri | 63110 | United States |
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| Label | URL |
|---|---|
| Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine | View source |
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Sharing of data collected by this project is essential to gain knowledge on how to improve and manage the current standard of care on high-risk and ovarian cancer patients.
The investigators will share data through multiple channels including:
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| ICF | No | No | Yes | Informed Consent Form | Oct 7, 2025 | May 6, 2026 | ICF_000.pdf |
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| ID | Term |
|---|---|
| D000013 | Congenital Abnormalities |
| ID | Term |
|---|---|
| D009358 | Congenital, Hereditary, and Neonatal Diseases and Abnormalities |
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| ID | Term |
|---|---|
| D014463 | Ultrasonography |
| ID | Term |
|---|---|
| D003952 | Diagnostic Imaging |
| D019937 | Diagnostic Techniques and Procedures |
| D003933 | Diagnosis |
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| Ultrasound | Device | -The ultrasound is being used in conjunction with the photoacoustic imaging |
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| Determine normal changes of photoacoustic imaging parameters |
The investigators expect to see small changes of the PAI/US imaging parameters of less than 10-15 for repeated measurements of 3 menstrual cycles |
| Through completion of follow-up (estimated to be 4.5 years) |