Vagina-View Safety and Imaging Feasibility

NCT07818850 | Recruiting

• 1 other identifier: 25-6017
• Study Type: interventional
• Target: 10
• Locations: 1 country
• Sites: 1

Brief Summary

This prospective, single-arm feasibility study evaluates the use of the Vagina-View (VV) device to guide the placement of a multichannel applicator (MCA) during vaginal brachytherapy. The study aims to determine whether the device can accurately visualize vaginal mucosal tumor involvement and improve the precision of MCA placement. By reducing the need for MRI guidance, the VV device may offer a less resource-intensive approach while minimizing radiation exposure to healthy vaginal tissue and potentially reducing treatment-related side effects. VV will not be used for participants' treatment planning and delivery. Only images will be taken with VV. The primary objective is to demonstrate the feasibility and positional accuracy of using the VV device for MCA placement.

Conditions

Vaginal Cancer

Outcome Measures

Primary Outcomes (1)

• Number and Location of Mucosal Disease Sites Identified Using the Vagina-View Grid Coordinate System

  Vaginal mucosal disease sites visualized with the Vagina-View (VV) device while in situ will be recorded and reported. Disease location will be documented using the VV grid coordinate system.

  1 month

Secondary Outcomes (4)

• Treatment device positioning versus MRI visualization

  1 month

• Extent of disease using optical visualization versus MRI

  1 month

• Extent of disease using optical visualization versus MRI

  1 month

• Mean Difference in Dosimetric Planning Parameters Between Vagina-View and Standard-of-Care Brachytherapy Plans

  1 month

Study Arms (1)

Vagina-View (VV) device

EXPERIMENTAL

Device: Vagina-View (VV) device

Interventions

Vagina-View (VV) device DEVICE

Placement of the VV applicator intravaginally during MCA brachytherapy. The VV is anticipated to be in the vagina for approximately 10-15 minutes. VV placement would be repeated for imaging scans only at each fraction of MCA brachytherapy (between 3 and 5 fractions in total). VV will not be used for participants' treatment planning and delivery. Only images will be taken with VV.

Vagina-View (VV) device

Eligibility Criteria

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

You may qualify if:

• Any patient with gynecological cancer who is planned to receive MRI-guided intravaginal brachytherapy with an MCA applicator.
• Able to receive and understand verbal and written information regarding study and able to give written informed consent

You may not qualify if:

• Patient receiving brachytherapy with a different brachytherapy device.
• Patient with contraindications to MRI.

Sponsors & Collaborators

• University Health Network, Toronto: lead

Study Sites (1)

Princess Margaret Cancer Centre

Toronto, Ontario, M5G 2M9, Canada

RECRUITING

MeSH Terms

Conditions

Vaginal Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: August 25, 2026
• First Posted: September 14, 2026
• Study Start: September 15, 2026
• Primary Completion (Estimated): December 30, 2028
• Study Completion (Estimated): December 30, 2028
• Last Updated: September 17, 2026

Record last verified: 2026-09

Locations

CA (1)