Ultrasound and Photoacoustic Imaging for Cervical Cancer

Not Applicable

Terminated

• Conditions: Cervical Cancer; Cancer of the Cervix
• Interventions: Device: Transvaginal probe using photoacoustic and ultrasound imaging

• Registration Number: NCT03318107
• Lead Sponsor: Washington University School of Medicine

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-10-17
• Study First Submitted QC: 2017-10-17
• Study First Posted: 2017-10-23
• Study Start: 2018-02-15
• Primary Completion: 2019-08-09
• Study Completion: 2019-08-09
• Status Verified: 2020-05
• Last Update Submitted: 2020-05-27
• Last Update Posted: 2020-05-29

Recruitment & Eligibility

• Status: TERMINATED
• Sex: Female
• Target Recruitment: 2

Inclusion Criteria

Not provided

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Exclusion Criteria

Not provided

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Transvaginal probe (Photoacoustic + ultrasound imaging)	Transvaginal probe using photoacoustic and ultrasound imaging	* 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

Primary Outcome Measures

Name	Time	Method
Number of participants who complete the imaging protocol	Approximately 18 weeks

Secondary Outcome Measures

Name	Time	Method
Reduction rate of tumor angiogenesis	3 months after completion of standard of care treatment (approximately 18 weeks)	* 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
Charge pattern of blood oxygen saturation	3 months after completion of standard of care treatment (approximately 18 weeks)	* 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

Trial Locations

Locations (1)

Washington University School of Medicine; 🇺🇸 Saint Louis, Missouri, United States