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

RECRUITINGSponsored by Duke University
Actively Recruiting
SponsorDuke University
Started2024-02-07
Est. completion2027-03
Eligibility
Age18 Years – 90 Years
SexFEMALE
Healthy vol.Accepted
Locations1 site
View on ClinicalTrials.gov →

NCT05977621

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

Age: 18 Years – 90 YearsSex: FEMALEHealthy volunteers accepted
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

Conditions2

CancerUterine Cancer

Locations1 site

Duke Cancer Center
Durham, North Carolina, 27710
Kaitlin Bailey, RN919-668-3726Kaitlin.Bailey@duke.edu

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