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

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05977621

Acronym

(TRUS)

Enrollment

Registered

2023-08-04

Start date

2024-02-07

Completion date

2027-03-01

Last updated

2026-03-06

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Uterine Cancer

Brief 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.

Interventions

OTHERTransrectal ultrasound (TRUS)

Transrectal ultrasound (TRUS) images of the female pelvis

Study design

Observational model

CASE_ONLY

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to 90 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Number of patients whose MRI and ultrasound images are fused	up to 5 weeks

Countries

United States

Contacts

CONTACTKaitlin Bailey, BNS RN

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

PRINCIPAL_INVESTIGATORDianda Ayala-Peacock, MD

Duke University Health System (DUHS)

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Mar 7, 2026