Ultrasound Microvessel Imaging for Ovarian Cancer

Overseen By Clinical Trials Referral Office

Age: 18+

Sex: Female

Trial Phase: Academic

Sponsor: Mayo Clinic

Must not be taking: Chemotherapy, Targeted therapy

Disqualifiers: Prior surgery, Pregnancy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: 1

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores a new ultrasound technique called ultrasound microvessel imaging (UMI) to better evaluate ovarian and adnexal lesions. The goal is to determine if UMI can more accurately detect small blood vessels, which might indicate a higher cancer risk compared to traditional ultrasounds. This advancement could aid in diagnosing ovarian cancer, known as the deadliest gynecologic cancer, often detected in advanced stages. The trial suits women scheduled for surgery to treat ovarian or adnexal lesions. As an unphased trial, participants can contribute to groundbreaking research that could enhance early cancer detection.

What prior data suggests that ultrasound microvessel imaging is safe for evaluating ovarian and adnexal lesions?

Research has shown that ultrasound microvessel imaging (UMI) offers a promising new method for examining blood flow in the ovaries. This technique provides better visualization of small blood vessels than traditional ultrasounds, aiding doctors in detecting ovarian tumors more easily.

Regarding safety, UMI is comparable to regular ultrasound. Ultrasounds are known to be safe and are widely used in medical care. Studies have not reported any harmful side effects specific to UMI, suggesting it is well-tolerated, similar to regular ultrasound methods.

Therefore, for those considering joining a trial using UMI, research indicates it should be as safe as a regular ultrasound. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about Ultrasound Microvessel Imaging (UMI) for ovarian cancer because it offers a new way to visualize blood vessels within tumors using advanced ultrasound techniques. Unlike standard imaging methods, which may not capture detailed blood flow information, UMI provides a clearer picture of the microvessels, potentially leading to earlier and more accurate detection. This method could revolutionize diagnostic capabilities and improve treatment planning by allowing doctors to assess tumor characteristics non-invasively and in real-time.

What evidence suggests that ultrasound microvessel imaging is effective for evaluating ovarian cancer?

Research shows that ultrasound microvessel imaging (UMI), which participants in this trial will undergo during a standard transvaginal ultrasound procedure, might better detect small blood vessels in ovarian and nearby areas than regular ultrasound methods. Studies have found that increased blood flow can indicate a higher risk of cancer. One study, in particular, found clear differences in the appearance of benign (non-cancerous) and malignant (cancerous) ovarian tumors using UMI. This suggests UMI might better distinguish between these types. Consequently, UMI could potentially enhance the accuracy of ovarian cancer diagnosis, which is crucial because early detection can greatly improve survival chances. ^{1 6 7 8 9}

Who Is on the Research Team?

Shigao D. Chen, PhD

Principal Investigator

Mayo Clinic

Are You a Good Fit for This Trial?

This trial is for patients scheduled for surgery to treat ovarian or adnexal lesions. It's aimed at improving diagnosis of these conditions, which could include benign tumors or ovarian cancer. Participants should be those who are already planned to undergo surgical treatment as part of their standard care.

Inclusion Criteria

I am a woman aged 18 or older.

I am scheduled for surgery to remove ovarian or related lesions.

Exclusion Criteria

I am currently receiving chemotherapy or targeted therapy before surgery.

Vulnerable populations, including prisoners, adults lacking capacity to consent, and pregnant women (our study coordinator will ask participants if they are pregnant; if uncertain, a urine pregnancy test will be offered at no cost)

I have had surgery to remove ovarian or related lesions.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Diagnostic Imaging

Participants undergo ultrasound microvessel imaging (UMI) during standard transvaginal ultrasound imaging procedure

1 day

1 visit (in-person)

Follow-up

Participants are monitored for safety and effectiveness after diagnostic imaging

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Ultrasound Microvessel Imaging

Trial Overview The study is testing a new ultrasound technique called Ultrasound Microvessel Imaging (UMI) against the traditional transvaginal ultrasound method. The goal is to see if UMI can better detect small blood vessels in ovarian and adnexal lesions, potentially indicating a higher risk of cancer.

How Is the Trial Designed?

Group I: Diagnostic (UMI, transvaginal ultrasound) Experimental Treatment 2 Interventions

Patients undergo UMI during standard transvaginal ultrasound imaging procedure on study.

Who Is Running the Clinical Trial?

Mayo Clinic

Lead Sponsor

Trials

3,427

Recruited

3,221,000+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT07280312?cond=cancer

Ultrasound Microvessel Imaging for the Evaluation of ... This clinical trial studies how well ultrasound microvessel imaging (UMI) works in evaluating ovarian and adnexal lesions in patients who are ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3101528/

Study on the Characteristics of Contrast-Enhanced ... Our results showed clear differences in enhancement patterns between benign and malignant ovary tumors or tumor-like lesions. The PI and AUC in the malignant ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S1048891X24077089

Enhancement of Ovarian Tumor Detection With αvβ3 ... The goal of this study was to examine the feasibility of αvβ 3 integrin single bond targeted molecular imaging agent in enhancing the detection of spontaneous ...

4. obgyn.onlinelibrary.wiley.com obgyn.onlinelibrary.wiley.com/doi/full/10.1002/uog.70087

Imaging in oncology - 2025 - Obstetrics and Gynecology - Wiley High-grade serous ovarian cancer (HGSOC) is the most aggressive subtype of ovarian cancer, with a 5-year survival rate of 47%. Given HGSOC's ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5788737/

Screening for ovarian cancer: imaging challenges and ... Across all screen-detected invasive epithelial ovarian cancers, the 5-year survival rate was 74.8% ± 6.6% compared with 53.7% ± 2.3% for unscreened patients ...

6. authorea.com authorea.com/users/872531/articles/1253066-applications-of-artificial-intelligence-and-multimodal-ultrasound-in-ovarian-cancer-diagnosis-and-prognosis-current-status-and-prospects

Applications of Artificial Intelligence and Multimodal ... Single-mode ultrasound imaging often fails to provide sufficient diagnostic information for ovarian cancer. Multimodal ultrasound combines ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9245046/

Diagnostic Value of Two-Dimensional Transvaginal ... Contrast-enhanced ultrasound technology can be used to evaluate the blood vessels of ovarian tumors, improve the sensitivity of ultrasound to the display of ...

8. sciencedirect.com sciencedirect.com/science/article/pii/S1048891X24042816

Enhancement of Ovarian Tumor Detection by DR6 ... This study showed that DR6-targeted imaging agents bind with their targets expressed by the malignant cells and tumor-associated microvessels in ovarian tumors ...

9. frontiersin.org frontiersin.org/journals/oncology/articles/10.3389/fonc.2024.1404426/full

Is three-dimensional ultrasonography a valuable ... Ovarian cancer (OC) is a major concern for women's health, accounting for 3.4% of female cancer cases and with a mortality rate of 4.7% (1).