Using ultrasound and photoacoustic imaging to improve ovarian cancer detection
Transvaginal Ultrasound and Photoacoustic Imaging of the Ovary
NA · Washington University School of Medicine · NCT04178018
This study is testing if a new imaging method that combines ultrasound and photoacoustic technology can help doctors better detect ovarian cancer and reduce unnecessary surgeries for patients at risk.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 310 (estimated) |
| Ages | 18 Years and up |
| Sex | Female |
| Sponsor | Washington University School of Medicine (other) |
| Locations | 1 site (Saint Louis, Missouri) |
| Trial ID | NCT04178018 on ClinicalTrials.gov |
What this trial studies
This study aims to validate the effectiveness of photoacoustic imaging combined with ultrasound in reducing unnecessary benign surgeries while maintaining sensitivity for cancer detection. It will involve consenting patients at risk for ovarian cancer or those with ovarian masses suggestive of malignancy who are scheduled for surgery. Additionally, the study will explore the potential of this imaging technique for early detection of ovarian cancer in high-risk patients who may opt for prophylactic surgery. Patients will be monitored over time to assess the outcomes of the imaging approach.
Who should consider this trial
Good fit: Ideal candidates include women aged 18 and older who are at risk for ovarian cancer and are referred for surgical procedures involving the ovaries.
Not a fit: Patients who are male or younger than 18 years old will not benefit from this study.
Why it matters
Potential benefit: If successful, this approach could lead to fewer unnecessary surgeries and improved early detection of ovarian cancer.
How similar studies have performed: Other studies have shown promise in using advanced imaging techniques for cancer detection, but this specific combination of photoacoustic imaging and ultrasound is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria for Primary and Secondary Outcome Measures * All patients, 18 years or older, referred to the Washington University School of Medicine for conditions necessitating surgery to include at least a unilateral oophorectomy. * Willingness to participate in the study and able to provide informed consent. Inclusion Criteria for Exploratory Outcome Measures * At least 18 years of age * Referred to the Washington University School of Medicine for conditions necessitating surgery to include at least a unilateral oophorectomy, an ovarian cystectomy, or a unilateral or bilateral salpingectomy . * Willing to be followed for one to 4.5 years prior to making the decision to undergo prophylactic oophorectomy. * Documented deleterious mutation in one of the following ovarian cancer genes: BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, PMS2, or EPCAM. Exclusion Criteria: * Male * Younger than 18 years of age
Where this trial is running
Saint Louis, Missouri
- Washington University School of Medicine — Saint Louis, Missouri, United States (RECRUITING)
Study contacts
- Principal investigator: Cary L Siegel, M.D. — Washington University School of Medicine
- Study coordinator: Cary L Siegel, M.D.
- Email: siegelc@wustl.edu
- Phone: 314-362-2928
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.