Trans-Rectal Ultrasound of the Female Pelvis for Real-Time MRI-US Fusion Based Needle Tracking

Part of paid clinical trials in Durham, North Carolina.

Sponsor
Duke University
Study ID
NCT05977621
Status
Recruiting
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Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - 90 Years
Healthy Volunteers
Not accepted

Interventions

  • Transrectal ultrasound (TRUS) — OTHER
    Transrectal ultrasound (TRUS) images of the female pelvis

Study Details

The purpose of this study is to utilize transrectal ultrasound (TRUS) images of the intact and post-hysterectomy female pelvis in order to provide feasibility information for a Magnetic Resonance Imaging (MRI)-TRUS fusion based 3D needle navigation system for use in image guided brachytherapy. The fusion and needle guidance will be performed using Eigen Health's navigation system that currently provides targeted MR/Ultrasound fusion based prostate biopsies utilizing a proprietary 3D semi-robotic navigation system.

Key Dates

Start date
Feb 7, 2024
Status verified
Feb 2026
Primary completion
Mar 31, 2027
Completion
Mar 31, 2027

Study Design

Enrollment
17 participants (estimated)

Arms

  • Arm: Intact anatomy
    Patients with intact anatomy (uterus and cervix)
  • Arm: Post-hysterectomy
    Post-hysterectomy patients (vaginal cuff) who are planned to receive brachytherapy

Primary Outcome Measure

Number of patients whose MRI and ultrasound images are fused [ Time Frame: up to 5 weeks ]

Central Contacts

Locations (1)

FacilityCityStateZIPSite coordinators
Duke Cancer CenterDurhamNorth Carolina27710
Kaitlin Bailey, RN
[email protected]
919-668-3726
Diandra Ayala-Peacock, MD (PRINCIPAL_INVESTIGATOR)

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