Ultrasound and Photoacoustic Imaging for Cervical Cancer

Sponsor
Washington University School of Medicine (Other)
Overall Status
Terminated
CT.gov ID
NCT03318107
Collaborator
(none)
2
1
1
17.7
0.1

Study Details

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Transvaginal probe using photoacoustic and ultrasound imaging
N/A

Study Design

Study Type:
Interventional
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 :
Feb 15, 2018
Actual Primary Completion Date :
Aug 9, 2019
Actual Study Completion Date :
Aug 9, 2019

Arms and Interventions

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

Outcome Measures

Primary Outcome Measures

  1. Number of participants who complete the imaging protocol [Approximately 18 weeks]

Secondary Outcome Measures

  1. 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

  2. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
18 Years and Older
Sexes Eligible for Study:
Female
Accepts Healthy Volunteers:
No
  • 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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 Washington University School of Medicine Saint Louis Missouri United States 63110

Sponsors and Collaborators

  • Washington University School of Medicine

Investigators

  • Principal Investigator: Perry W Grigsby, M.D., Washington University School of Medicine

Study Documents (Full-Text)

None provided.

More Information

Additional Information:

Publications

None provided.
Responsible Party:
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT03318107
Other Study ID Numbers:
  • 201710024
First Posted:
Oct 23, 2017
Last Update Posted:
May 29, 2020
Last Verified:
May 1, 2020
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
No
Additional relevant MeSH terms:

Study Results

No Results Posted as of May 29, 2020