Ultrasound and Photoacoustic Imaging for Cervical Cancer

Study Overview
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Brief Summary
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The investigators have developed co-registered transvaginal photoacoustic and ultrasound (US) imaging techniques that allow them to visualize ovarian tumor structure and functional changes simultaneously, which may potentially reveal early tumor angiogenesis development or residual tumors after systemic treatment that is not available by US alone. The ability to detect early angiogenesis changes, as well as tumor morphology changes using a non-invasive imaging modality will greatly enhance the care for patients. The investigators plan to explore these techniques in monitoring cervical cancer treatment response and conduct pilot feasibility studies.

Official Title
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Pilot Study of Ultrasound and Photoacoustic Imaging for Assessing Treatment Response of Cervical Cancer Patients

Conditions
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Cervical Cancer, Cancer of the Cervix

Intervention / Treatment
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* Device: Transvaginal probe using photoacoustic and ultrasound imaging


Participation Criteria
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Eligibility Criteria
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Diagnosis of cervical cancer of any stage that will be treated with radiation therapy and concurrent chemotherapy. At least 18 years of age. Not pregnant and/or breastfeeding. Able to understand and willing to sign an IRB-approved written informed consent document.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Transvaginal probe (Photoacoustic + ultrasound imaging)<br>A transvaginal imaging probe using ultrasound and photoacoustic imaging will be inserted into the vagina and will use different frequencies of lights to create images This will occur before the first standard of care treatment, mid-treatment, end of treatment, and approximately 3 months after the end of treatment for a total of 4 imaging time points | Device: Transvaginal probe using photoacoustic and ultrasound imaging<br>* -Four optical wavelengths of 730nm, 780nm, 800 nm, and 830 nm will be used to acquire data<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of participants who complete the imaging protocol |  | Approximately 18 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Reduction rate of tumor angiogenesis | The reduction rate of tumor angiogenesis of clinical responders and non-responders will be analyzed Responders and non-responders will be determined by standard of care PET imaging based on F18-FDG uptake, 3 months after completion of treatment | 3 months after completion of standard of care treatment (approximately 18 weeks) | 
| Charge pattern of blood oxygen saturation | The charge pattern of blood oxygen saturation of clinical responders and non-responders will be analyzed Responders and non-responders will be determined by standard of care PET imaging based on F18-FDG uptake, 3 months after completion of treatment | 3 months after completion of standard of care treatment (approximately 18 weeks) |