RecruitingNot Applicable

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

United States17 participantsStarted 2024-02-07

Plain-language 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.

Who can participate

Age range18 Years – 90 Years

SexFEMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Number of patients whose MRI and ultrasound images are fused

Timeframe: up to 5 weeks

Trial details

NCT IDNCT05977621

SponsorDuke University

Sponsor typeOTHER

Study typeOBSERVATIONAL

Primary completion2027-03

Contact for this trial

Kaitlin Bailey, BNS RN

(919) 668-3726 Kaitlin.Bailey@duke.edu

View on ClinicalTrials.gov More Uterine Cancer trials