Back to resultsUltrasound and Photoacoustic Imaging for Cervical Cancer
Primary Purpose
Cervical Cancer, Cancer of the Cervix
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Transvaginal probe using photoacoustic and ultrasound imaging
Sponsored by
About this trial
This is an interventional diagnostic trial for Cervical Cancer
Eligibility Criteria
- 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.
Sites / Locations
- Washington University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Transvaginal probe (Photoacoustic + ultrasound imaging)
Arm Description
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
Outcomes
Primary Outcome Measures
Number of participants who complete the imaging protocol
Secondary Outcome Measures
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
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
Full Information
NCT ID
NCT03318107
First Posted
October 17, 2017
Last Updated
May 27, 2020
Sponsor
Washington University School of Medicine
1. Study Identification
Unique Protocol Identification Number
NCT03318107
Brief Title
Ultrasound and Photoacoustic Imaging for Cervical Cancer
Official Title
Pilot Study of Ultrasound and Photoacoustic Imaging for Assessing Treatment Response of Cervical Cancer Patients
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Terminated
Why Stopped
Low accrual
Study Start Date
February 15, 2018 (Actual)
Primary Completion Date
August 9, 2019 (Actual)
Study Completion Date
August 9, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Washington University School of Medicine
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cervical Cancer, Cancer of the Cervix
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
2 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Transvaginal probe (Photoacoustic + ultrasound imaging)
Arm Type
Experimental
Arm Description
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
Intervention Type
Device
Intervention Name(s)
Transvaginal probe using photoacoustic and ultrasound imaging
Intervention Description
-Four optical wavelengths of 730nm, 780nm, 800 nm, and 830 nm will be used to acquire data
Primary Outcome Measure Information:
Title
Number of participants who complete the imaging protocol
Time Frame
Approximately 18 weeks
Secondary Outcome Measure Information:
Title
Reduction rate of tumor angiogenesis
Description
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
Time Frame
3 months after completion of standard of care treatment (approximately 18 weeks)
Title
Charge pattern of blood oxygen saturation
Description
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
Time Frame
3 months after completion of standard of care treatment (approximately 18 weeks)
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Perry W Grigsby, M.D.
Organizational Affiliation
Washington University School of Medicine
Official's Role
Principal Investigator
Facility Information:
Facility Name
Washington University School of Medicine
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63110
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Links:
URL
http://www.siteman.wustl.edu
Description
Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine
Learn more about this trial
Ultrasound and Photoacoustic Imaging for Cervical Cancer
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