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Ultrasound and Photoacoustic Imaging for Cervical Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03318107
Recruitment Status : Terminated (Low accrual)
First Posted : October 23, 2017
Last Update Posted : May 29, 2020
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Cancer of the Cervix Device: Transvaginal probe using photoacoustic and ultrasound imaging Not Applicable

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 2 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Pilot Study of Ultrasound and Photoacoustic Imaging for Assessing Treatment Response of Cervical Cancer Patients
Actual Study Start Date : February 15, 2018
Actual Primary Completion Date : August 9, 2019
Actual Study Completion Date : August 9, 2019

Resource links provided by the National Library of Medicine


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




Primary Outcome Measures :
  1. Number of participants who complete the imaging protocol [ Time Frame: Approximately 18 weeks ]

Secondary Outcome Measures :
  1. 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

  2. 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



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03318107


Locations
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United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Investigators
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Principal Investigator: Perry W Grigsby, M.D. Washington University School of Medicine
Additional Information:
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Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT03318107    
Other Study ID Numbers: 201710024
First Posted: October 23, 2017    Key Record Dates
Last Update Posted: May 29, 2020
Last Verified: May 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases
Genital Diseases, Female