Ultrasound and Photoacoustic Imaging for Cervical Cancer

NCT03318107 | Terminated DMC

• 1 other identifier: 201710024
• Study Type: interventional
• Target: 2
• Locations: 1 country
• Sites: 1

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.

Conditions

Cervical Cancer; Cancer of the Cervix

Outcome Measures

Primary Outcomes (1)

• Number of participants who complete the imaging protocol

  Approximately 18 weeks

Secondary Outcomes (2)

• Reduction rate of tumor angiogenesis

  3 months after completion of standard of care treatment (approximately 18 weeks)

• Charge pattern of blood oxygen saturation

  3 months after completion of standard of care treatment (approximately 18 weeks)

Study Arms (1)

Transvaginal probe (Photoacoustic + ultrasound imaging)

EXPERIMENTAL

* 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

Interventions

Transvaginal probe using photoacoustic and ultrasound imaging DEVICE

-Four optical wavelengths of 730nm, 780nm, 800 nm, and 830 nm will be used to acquire data

Transvaginal probe (Photoacoustic + ultrasound imaging)

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

* 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.

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Uterine Cervical Neoplasms

Interventions

Ultrasonography

Condition Hierarchy (Ancestors)

Uterine Neoplasms; Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Cervical Diseases; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis

Study Officials

• Perry W Grigsby, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 17, 2017
• First Posted: October 23, 2017
• Study Start: February 15, 2018
• Primary Completion: August 9, 2019
• Study Completion: August 9, 2019
• Last Updated: May 29, 2020

Record last verified: 2020-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)