What side effects are associated with this type of intervention?

Common treatments for ovarian anomalies, particularly those involving advanced imaging techniques like photoacoustic imaging, generally have minimal side effects. Photoacoustic imaging itself is a non-invasive procedure that uses laser-induced ultrasound waves to create detailed tissue images, and it is primarily being studied for its potential to reduce unnecessary surgeries without compromising cancer detection sensitivity. Known side effects of similar imaging techniques, such as ultrasound, are typically mild and may include temporary discomfort or minor skin irritation at the site of the procedure. However, more invasive procedures or those involving higher energy levels, like certain types of laser therapy, can potentially cause tissue damage, pain, or thermal injuries. Overall, the side effects are generally minimal and manageable.

What prior FDA approvals exist?

FDA approvals for the treatment of ovarian anomalies have primarily focused on drugs and therapies for conditions like ovarian cancer and PCOS. For ovarian cancer, treatments include chemotherapy agents such as paclitaxel and carboplatin, as well as targeted therapies like PARP inhibitors (e.g., olaparib). While photoacoustic imaging is an emerging technique under investigation for its potential to improve early detection and reduce unnecessary surgeries, it has not yet received FDA approval specifically for ovarian anomalies. Current approved imaging techniques for ovarian conditions include transvaginal ultrasound, which is widely used for monitoring and diagnosis.

What other types of research exist?

Promising alternatives to Photoacoustic Imaging for ovarian anomaly patients include: 1) Advanced 3D and 4D ultrasound imaging, which provides detailed volumetric images and real-time assessment of ovarian structures. 2) Narrow-band imaging (NBI), which enhances the visualization of superficial lesions and vascular patterns. 3) Autofluorescence imaging, which improves the detection of subtle tissue changes. 4) High-resolution MRI with contrast agents, offering detailed soft tissue characterization and improved detection of small lesions. These technologies are expected to enhance diagnostic accuracy and guide treatment decisions effectively.

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Ultrasound + Photoacoustic Imaging for Ovarian Health

N/A

Recruiting

Led By Cary L Siegel, M.D.

Research Sponsored by Washington University School of Medicine

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Documented deleterious mutation in one of the following ovarian cancer genes: BRCA1, BRCA2, BRIP1, PALB2, RAD51C, RAD51D, BARD1, MSH2, MSH6, MLH1, PMS2, or EPCAM.

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through completion of follow-up (estimated to be 4.5 years)

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new imaging technique that uses light and sound to help doctors see inside the body. It aims to help high-risk ovarian cancer patients avoid unnecessary surgeries while still detecting cancer early.

Who is the study for?

This trial is for adults who may carry certain genetic mutations linked to ovarian cancer (like BRCA1/2) and are referred for surgery that includes removal of at least one ovary. Participants should be willing to be monitored for 1-2 years before deciding on preventive ovary removal.

What is being tested?

The study tests if photoacoustic imaging, combined with ultrasound, can reduce unnecessary surgeries while still effectively detecting ovarian cancer, especially in early stages among high-risk patients.

What are the potential side effects?

Since the interventions involve non-invasive imaging techniques like photoacoustic imaging and ultrasound, there are typically no significant side effects associated with these procedures.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My ovarian cancer has a harmful mutation in a specific gene.

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I am 18 or older and need surgery that includes removing one ovary.

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I am referred to Washington University for surgery that includes removing one ovary.

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I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through completion of follow-up (estimated to be 4.5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through completion of follow-up (estimated to be 4.5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through completion of follow-up (estimated to be 4.5 years) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

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)

Secondary study objectives

Malignant Neoplasms

Other study objectives

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

Determine normal changes of photoacoustic imaging parameters

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

Trial Design

1Treatment groups

Experimental Treatment

Group I: Transvaginal photoacoustic imaging/ultrasoundExperimental Treatment2 Interventions

* Baseline transvaginal ultrasound (standard of care) followed by transvaginal ultrasound and photoacoustic imaging for all participants enrolled * Once the surgeon has surgically removed the ovary(ies), they will be imaged with the photoacoustic imaging/ultrasound * For the exploratory outcome measure for high risk participants (approximately 50 participants), the transvaginal ultrasound (standard of care) followed by transvaginal ultrasound and photoacoustic imaging will be performed additionally at 6 months, 12 months, 18 months, 24 months, and at the time of surgery * For the exploratory outcome measure for high risk participants (approximately 10 participants), the transvaginal ultrasound (standard of care) followed by transvaginal ultrasound and photoacoustic imaging will be performed additionally every 2 weeks at follicular phase and at the luteal phase for 3 months

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Ultrasound

2013

Completed Phase 1

~4090

0 / 4Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for ovarian anomalies include surgical intervention, hormonal therapy, and advanced imaging techniques like photoacoustic imaging. Surgical intervention aims to remove or repair abnormal ovarian tissue, while hormonal therapy regulates or suppresses ovarian function to manage symptoms. Photoacoustic imaging, which uses laser-induced ultrasound waves to create detailed tissue images, helps in early detection and accurate diagnosis of ovarian anomalies. This matters for patients as it can reduce the need for invasive surgeries, improve diagnostic accuracy, and enable timely and targeted treatment, ultimately enhancing patient outcomes and quality of life.

Evidence for an absence of deleterious effects of ultrasound on human oocytes.Ultrasonically induced morphological damage to mouse ovaries.Ultrasound observations in patients on gonadotrophin therapy.