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

Acquisition of Trans-Rectal Ultrasound [TRUS] Images of the Female Pelvis for Real-Time MRI-US Fusion Based Needle Tracking for Image-Guided Brachytherapy: A Pre-feasibility Study

Who can join

Ages 18 to 90 · Women

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

About the study

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.

What is being tested

• Transrectal ultrasound (TRUS) (other)

Sponsor: Duke University · Participants: 17 · Started: Feb 7, 2024

Contact the study team

• Kaitlin Bailey, BNS RN · Phone: (919) 668-3726

Official record on ClinicalTrials.gov — NCT05977621

Locations in the U.S.

Conditions

• Uterine Cancer

From ClinicalTrials.gov, data retrieved Sep 30, 2026. Each study sets its own eligibility; the study team decides who can join.