NCT05977621Recruiting

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

Duke University

Start Date

2/7/2024

Completion Date

3/1/2027

Summary

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.

Eligibility Criteria

Age Range: 18 years to 90 years

Inclusion Criteria: * Histologically proven invasive primary squamous, adenosquamous, or adenocarcinoma of the uterine cervix, (recurrent or medically inoperable) uterine adenocarcinoma. * Treatment plan must include curative-intent definitive radiation that includes brachytherapy treatments with or without concurrent chemotherapy * Adults ≥ 18 years of age * ECOG Performance Status 0-2 Exclusion Criteria: * Patients with active rectal bleeding or rectal ulcer

Interventions

OTHER

Transrectal ultrasound (TRUS)

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Conditions

Uterine Cancer

Locations

Duke Cancer Center

Durham, North Carolina 27710

United States