Ultrasound and Photoacoustic Imaging for Cervical Cancer

May 27, 2020 updated by: Washington University School of Medicine

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

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.

Study Overview

Status

Terminated

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

2

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United States
    • Missouri
      • Saint Louis, Missouri, United States, 63110
        • Washington University School of Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: DIAGNOSTIC
  • Allocation: NA
  • Interventional Model: SINGLE_GROUP
  • Masking: NONE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: Transvaginal probe (Photoacoustic + 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
Device: Transvaginal probe using photoacoustic and ultrasound imaging
-Four optical wavelengths of 730nm, 780nm, 800 nm, and 830 nm will be used to acquire data

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of participants who complete the imaging protocol
Time Frame: Approximately 18 weeks
Approximately 18 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Reduction rate of tumor angiogenesis
Time Frame: 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
3 months after completion of standard of care treatment (approximately 18 weeks)
Charge pattern of blood oxygen saturation
Time Frame: 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
3 months after completion of standard of care treatment (approximately 18 weeks)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Washington University School of Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

February 15, 2018

Primary Completion (ACTUAL)

August 9, 2019

Study Completion (ACTUAL)

August 9, 2019

Study Registration Dates

First Submitted

October 17, 2017

First Submitted That Met QC Criteria

October 17, 2017

First Posted (ACTUAL)

October 23, 2017

Study Record Updates

Last Update Posted (ACTUAL)

May 29, 2020

Last Update Submitted That Met QC Criteria

May 27, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 201710024

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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