Ultrasound + Photoacoustic Imaging for Ovarian Health
Recruiting in Palo Alto (17 mi)
Age: 18+
Sex: Female
Travel: May Be Covered
Time Reimbursement: Varies
Trial Phase: Academic
Recruiting
Sponsor: Washington University School of Medicine
Disqualifiers: Male, Younger than 18, others
No Placebo Group
Trial Summary
What is the purpose of this trial?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.
Will I have to stop taking my current medications?
The trial information does not specify whether you need to stop taking your current medications.
What data supports the effectiveness of the treatment Ultrasound + Photoacoustic Imaging for Ovarian Health?
Research shows that combining photoacoustic imaging (which uses laser light to create images based on tissue blood supply) with ultrasound can help detect ovarian cancer earlier and distinguish between benign and malignant ovarian masses. This combination has shown promise in improving early diagnosis, which is crucial since early-stage detection significantly increases the chances of successful treatment.
12345Is ultrasound and photoacoustic imaging safe for human use?
The studies show that the laser energy used in photoacoustic imaging is below the safety limits set by the American National Standards Institute, suggesting it is safe for human use. Additionally, the imaging system has been tested on human ovarian tissues and healthy volunteers without reported safety issues.
46789How does the ultrasound and photoacoustic imaging treatment for ovarian health differ from other treatments?
This treatment combines ultrasound with photoacoustic imaging, a novel technique that uses laser-induced sound waves to create detailed images of tissue. Unlike traditional imaging methods, it provides both anatomical and functional information, which can help in early detection and differentiation of ovarian cancer from benign conditions.
1351011Eligibility Criteria
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.Inclusion Criteria
My ovarian cancer has a harmful mutation in a specific gene.
I am willing to be monitored for 1-2 years before deciding on preventive ovary removal.
I am willing and able to give my consent to participate in the study.
+5 more
Trial Timeline
Screening
Participants are screened for eligibility to participate in the trial
2-4 weeks
Baseline Imaging
Baseline transvaginal ultrasound (standard of care) followed by transvaginal ultrasound and photoacoustic imaging for all participants enrolled
1 day
1 visit (in-person)
Surgical Procedure and Imaging
Once the surgeon has surgically removed the ovary(ies), they will be imaged with the photoacoustic imaging/ultrasound
At the time of surgery (estimated to be 2 weeks)
Exploratory Imaging Follow-up
For high-risk participants, transvaginal ultrasound and photoacoustic imaging will be performed at 6, 12, 18, 24 months, and at the time of surgery
24 months
Multiple visits (in-person)
Menstrual Cycle Imaging
For a subset of high-risk participants, imaging will be performed every 2 weeks at follicular and luteal phases for 3 months
3 months
Multiple visits (in-person)
Follow-up
Participants are monitored for safety and effectiveness after treatment
4.5 years
Participant Groups
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.
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
Find a Clinic Near You
Research Locations NearbySelect from list below to view details:
Washington University School of MedicineSaint Louis, MO
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Who Is Running the Clinical Trial?
Washington University School of MedicineLead Sponsor
National Cancer Institute (NCI)Collaborator
References
A review of co-registered transvaginal photoacoustic and ultrasound imaging for ovarian cancer diagnosis. [2022]Ovarian cancer is the deadliest of all gynecological malignancies. When ovarian cancer is detected at an early, localized stage, surgery and chemotherapy can cure 70%-90% of patients, compared with 20% or fewer when it is diagnosed at later stages. Clearly, early detection is critical, yet the lack of early symptoms and effective screening tools means that only 20-25% of ovarian cancers are diagnosed early. Photoacoustic imaging (PAI) is an emerging modality that uses a short-pulsed laser to excite tissue. The resulting photoacoustic waves are used to image tissue optical contrast, which is directly related to tissue microvasculature and thus to cancer growth. When co-registered with transvaginal ultrasound (US), PAI offers great promise in diagnosing earlier stage ovarian cancers and distinguishing benign processes from malignant ovarian masses. In this article, we review the limitations of the current imaging tools for early ovarian cancer diagnosis and present recent advances in co-registered PAI/US.
Characterization of adnexal lesions using photoacoustic imaging to improve sonographic O-RADS risk assessment. [2023]To assess the impact of photoacoustic imaging (PAI) on the assessment of ovarian/adnexal lesion(s) of different risk categories using the sonographic ovarian-adnexal imaging-reporting-data system (O-RADS) in women undergoing planned oophorectomy.
Coregistered three-dimensional ultrasound and photoacoustic imaging system for ovarian tissue characterization. [2023]Ovarian cancer has the highest mortality of all gynecologic cancers, with a five-year survival rate of only 30% or less. Current imaging techniques are limited in sensitivity and specificity in detecting early stage ovarian cancer prior to its widespread metastasis. New imaging techniques that can provide functional and molecular contrasts are needed to reduce the high mortality of this disease. One such promising technique is photoacoustic imaging. We develop a 1280-element coregistered 3-D ultrasound and photoacoustic imaging system based on a 1.75-D acoustic array. Volumetric images over a scan range of 80 deg in azimuth and 20 deg in elevation can be achieved in minutes. The system has been used to image normal porcine ovarian tissue. This is an important step toward better understanding of ovarian cancer optical properties obtained with photoacoustic techniques. To the best of our knowledge, such data are not available in the literature. We present characterization measurements of the system and compare coregistered ultrasound and photoacoustic images of ovarian tissue to histological images. The results show excellent coregistration of ultrasound and photoacoustic images. Strong optical absorption from vasculature, especially highly vascularized corpora lutea and low absorption from follicles, is demonstrated.
A Coregistered Ultrasound and Photoacoustic Imaging Protocol for the Transvaginal Imaging of Ovarian Lesions. [2023]Ovarian cancer remains the deadliest of all the gynecological malignancies due to the lack of reliable screening tools for early detection and diagnosis. Photoacoustic imaging or tomography (PAT) is an emerging imaging modality that can provide the total hemoglobin concentration (relative scale, rHbT) and blood oxygen saturation (%sO2) of ovarian/adnexal lesions, which are important parameters for cancer diagnosis. Combined with coregistered ultrasound (US), PAT has demonstrated great potential for detecting ovarian cancers and for accurately diagnosing ovarian lesions for effective risk assessment and the reduction of unnecessary surgeries of benign lesions. However, PAT imaging protocols in clinical applications, to our knowledge, largely vary among different studies. Here, we report a transvaginal ovarian cancer imaging protocol that can be beneficial to other clinical studies, especially those using commercial ultrasound arrays for the detection of photoacoustic signals and standard delay-and-sum beamforming algorithms for imaging.
Combined optoacoustic/ultrasound system for tomographic absorption measurements: possibilities and limitations. [2016]In this paper, we present the OPUS (optoacoustic plus ultrasound) system, which is a combination of a wavelength-tunable pulsed optical parametrical oscillator (OPO) laser with a commercial ultrasound (US) scanner. Optoacoustic (OA) or, synonymously, photoacoustic (PA) imaging is a spectroscopic technique to measure optical absorption in semitransparent solids and liquids. The measured signal is an acoustical pressure wave, which represents the absorption of pulsed optical radiation. By temporally and spatially resolved detection of the pressure wave on the sample surface, a 2D or even 3D image of the distribution of the optical absorption in the sample can be generated. In recent years, OA tomography has found increasing application in medical imaging. Most of these applications are based on qualitative OA imaging. The reported system is intended primarily for breast cancer detection, in which the optoacoustic imaging modality offers additional information to the ultrasound image. Consequently, the system is developed in a way that the OA imaging mode can be installed without major changes to the US instrument. The capabilities of the OPUS system for the quantitative analysis of absorber concentrations in tissue models are exploited.
Design of optimal light delivery system for co-registered transvaginal ultrasound and photoacoustic imaging of ovarian tissue. [2020]A hand-held transvaginal probe suitable for co-registered photoacoustic and ultrasound imaging of ovarian tissue was designed and evaluated. The imaging probe consists of an ultrasound transducer and four 1-mm-core multi-mode optical fibers both housed in a custom-made sheath. The probe was optimized for the highest light delivery output and best beam uniformity on tissue surface, by simulating the light fluence and power output for different design parameters. The laser fluence profiles were experimentally measured through chicken breast tissue and calibrated intralipid solution at various imaging depths. Polyethylene tubing filled with rat blood mimicking a blood vessel was successfully imaged up to ∼30 mm depth through porcine vaginal tissue at 750 nm. This imaging depth was achieved with a laser fluence on the tissue surface of 20 mJ/cm(2), which is below the maximum permissible exposure (MPE) of 25 mJ/cm(2) recommended by the American National Standards Institute (ANSI). Furthermore, the probe imaging capability was verified with ex vivo imaging of benign and malignant human ovaries. The co-registered images clearly showed different vasculature distributions on the surface of the benign cyst and the malignant ovary. These results suggest that our imaging system has the clinical potential for in vivo imaging and characterization of ovarian tissues.
Optoacoustic Breast Imaging: Imaging-Pathology Correlation of Optoacoustic Features in Benign and Malignant Breast Masses. [2019]Optoacoustic ultrasound breast imaging is a fused anatomic and functional modality that shows morphologic features, as well as hemoglobin amount and relative oxygenation within and around breast masses. The purpose of this study is to investigate the positive predictive value (PPV) of optoacoustic ultrasound features in benign and malignant masses.
Combined Pulse-Echo Ultrasound and Multispectral Optoacoustic Tomography With a Multi-Segment Detector Array. [2018]The high complementarity of ultrasonography and optoacoustic tomography has prompted the development of combined approaches that utilize the same transducer array for detecting both optoacoustic and pulse-echo ultrasound responses from tissues. Yet, due to the fundamentally different physical contrast and image formation mechanisms, the development of detection technology optimally suited for image acquisition in both modalities remains a major challenge. Herein, we introduce a multi-segment detector array approach incorporating array segments of linear and concave geometry to optimally support both ultrasound and optoacoustic image acquisition. The various image rendering strategies are tested and optimized in numerical simulations and calibrated tissue-mimicking phantom experiments. We subsequently demonstrate real-time hybrid optoacoustic ultrasound image acquisition in a healthy volunteer. The new approach enables the acquisition of high-quality anatomical data by both modalities complemented by functional information on blood oxygenation status provided by the multispectral optoacoustic tomography.
Co-registered pulse-echo/photoacoustic transvaginal probe for real time imaging of ovarian tissue. [2021]We present the design and construction of a prototype imaging probe capable of co-registered pulse-echo ultrasound and photoacoustic (optoacoustic) imaging in real time. The probe consists of 36 fibers of 200 micron core diameter each that are distributed around a commercial transvaginal ultrasound transducer, and housed in a protective shield. Its performance was demonstrated by two sets of experiments. The first set involved imaging of blood flowing through a tube mimicking a blood vessel, the second set involved imaging of human ovaries ex vivo. The results suggest that the system along with the probe has great potential for imaging and characterizing of ovarian tissue in vivo.
Multispectral optoacoustic tomography of the human breast: characterisation of healthy tissue and malignant lesions using a hybrid ultrasound-optoacoustic approach. [2020]Multispectral optoacoustic tomography (MSOT) represents a new in vivo imaging technique with high resolution (~250 μm) and tissue penetration (>1 cm) using the photoacoustic effect. While ultrasound contains anatomical information for lesion detection, MSOT provides functional information based on intrinsic tissue chromophores. We aimed to evaluate the feasibility of combined ultrasound/MSOT imaging of breast cancer in patients compared to healthy volunteers.
Development of Multispectral Optoacoustic Tomography as a Clinically Translatable Modality for Cancer Imaging. [2023]The use of optoacoustic imaging takes advantage of the photoacoustic effect to generate high-contrast, high-resolution medical images at penetration depths of up to 5 cm. Multispectral optoacoustic tomography (MSOT) is a type of optoacoustic imaging system that has seen promising preclinical success with a recent emergence into the clinic. Multiwavelength illumination of tissue allows for the mapping of multiple chromophores, which are generated endogenously or exogenously. However, translation of MSOT to the clinic is still in its preliminary stages. For successful translation, MSOT requires refinement of probes and data-acquisition systems to tailor to the human body, along with more intuitive, real-time visualization settings. The possibilities of optoacoustic imaging, namely MSOT, in the clinic are reviewed here. ©RSNA, 2020.