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

Recruiting now

Conditions studied: Uterine Cancer

In brief

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 facts

Study ID

NCT05977621

Run by

Duke University

People needed

17

Starts

2024-02-07

Expected to finish

2027-03-01

Last updated by the study team

2026-03-06

Who can join

Age: 18 and older, up to 90. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• Patients with active rectal bleeding or rectal ulcer

Where it is running

• Duke Cancer Center — Durham, North Carolina, United States (enrolling)

Full record on ClinicalTrials.gov

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