Ultrasound and Photoacoustic Imaging for Cervical Cancer

Cervical Cancer Clinical Trial

Official title:

Pilot Study of Ultrasound and Photoacoustic Imaging for Assessing Treatment Response of Cervical Cancer Patients

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT03318107
• Other study ID #: 201710024
• Status: Terminated
• Phase: N/A
• Start date: February 15, 2018
• Est. completion date: August 9, 2019

Study information

• Verified date: May 2020
• Source: Washington University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Terminated
• Enrollment: 2
• Est. completion date: August 9, 2019
• Est. primary completion date: August 9, 2019
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

• 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.

Related Conditions & MeSH terms

• Cancer of the Cervix
• Cervical Cancer
• Uterine Cervical Neoplasms

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

Locations

Country	Name	City	State
United States	Washington University School of Medicine	Saint Louis	Missouri

Sponsors (1)

Lead Sponsor	Collaborator
Washington University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of participants who complete the imaging protocol		Approximately 18 weeks
Secondary	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	3 months after completion of standard of care treatment (approximately 18 weeks)
Secondary	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	3 months after completion of standard of care treatment (approximately 18 weeks)

External Links

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