Ultrasound and Photoacoustic Imaging for Cervical Cancer

ID: NCT03318107
Status: Recruiting
Phase: Phase 1
Start Date: February 15, 2018
First Submitted: October 17, 2017
Last Updated: February 20, 2018
Results: N/A
Sponsors & Collaborators: Washington University School of Medicine
Location: United States
Conditions: Cervical Cancer, Cancer of the Cervix
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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.

Detailed Description

Condition or disease Intervention/treatment Phase

Cancer of the Cervix

Cervical Cancer

Device: Transvaginal probe using photoacoustic and ultrasound imaging
Other Names
Phase 1

Tracking Information

First Submitted DateOctober 17, 2017
Last Update Posted DateFebruary 20, 2018
Actual Start DateFebruary 15, 2018
Anticipated Completion DateMay 30, 2019
Actual Primary Completion DateMay 30, 2019
Results First Submitted DateN/A
Received Results Disposit DateN/A

Current Primary Outcome Measures

  • Number of participants who complete the imaging protocol [Time Frame: 6 weeks]

Original Primary Outcome Measures

Not Available

Current Secondary Outcome Measures

  • Reduction rate of tumor angiogenesis [Time Frame: 3 months after completion of standard of care treatment]

    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 [Time Frame: 3 months after completion of standard of care treatment]

    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

Original Secondary Outcome Measures

Not Available

Study Design

Brief TitleUltrasound and Photoacoustic Imaging for Cervical Cancer
Official TitlePilot Study of Ultrasound and Photoacoustic Imaging for Assessing Treatment Response of Cervical Cancer Patients
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

Study TypeInterventional
Study PhasePhase 1
Estimated Enrollment
10
Allocation
Not Available
Interventional Model
Single Group Assignment
Masking
None (Open Label)
Primary Purpose
Diagnostic
Conditions
Cancer of the Cervix
Cervical Cancer
Target Follow-Up Duration N/A
Biospecimen:
N/A
Sampling MethodN/A
Study PopulationN/A
Intervention
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

Other Names
Study Groups/Cohorts
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 your first standard of care treatment and before each weekly standard of care brachytherapy procedures for a total of 7 imaging time points

Study Arms
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 your first standard of care treatment and before each weekly standard of care brachytherapy procedures for a total of 7 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

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 your first standard of care treatment and before each weekly standard of care brachytherapy procedures for a total of 7 imaging time points
Device : Transvaginal probe using photoacoustic and ultrasound imaging

Recruitment Information

Recruitment Status:Recruiting
Enrollment10
Completion DateMay 30, 2019
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.
GenderFemale
Age18 Years to N/A
Accepts Healthy VolunteersNo
Contacts
Listed Location Countries
United States

Administrative Information

NCT Number:NCT03318107
Other Study ID Numbers
201710024
Has Data Monitoring CommitteeYes
U.S. FDA-regulated Product Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Device Product Not Approved or Cleared by U.S. FDA: No
IPD Sharing Statement
Not Available
Responsible Party,
Study Sponsor
Washington University School of Medicine
Collaborators
Not Available
Investigators
Principal Investigator
Perry W Grigsby, M.D.
Washington University School of Medicine