Recruiting

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

Sponsor:

Duke University

Code:

NCT05977621

Conditions

Uterine Cancer

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not accepted

Interventions

Transrectal ultrasound (TRUS)

Study Details

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.

Conditions

Uterine Cancer

Study ID

NCT05977621

Start date

Feb 7, 2024

Status verified date

Feb, 2026

Completion date

Mar, 2027

Anticipated

Primary completion date

Mar, 2027

Anticipated

Eligibility Criteria

Sex: Female

Age: 18 - 70+

Healthy Volunteers: Not 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

Study Design

Enrollment

17 participants

Anticipated

Interventions and Outcome Measures

Arms

Intact anatomy

Patients with intact anatomy (uterus and cervix)

Post-hysterectomy

Post-hysterectomy patients (vaginal cuff) who are planned to receive brachytherapy

Interventions

Transrectal ultrasound (TRUS)

Transrectal ultrasound (TRUS) images of the female pelvis

Primary outcome measure

Number of patients whose MRI and ultrasound images are fused [ Time Frame: up to 5 weeks ]

Central Contacts and Locations

Central contacts

Kaitlin Bailey, BNS RN

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

Locations

Duke Cancer Center

Recruiting

Durham, North Carolina, United States, 27710

Contacts

Kaitlin Bailey, RN

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

Principal Investigator:

Diandra Ayala-Peacock, MD

More Information

Sponsor

Duke University

Last update posted

Mar 6, 2026

Last verified

Feb, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-10-25. This information was provided to ClinicalTrials.gov by Duke University on 2026-03-06. Recruitment status is synced daily from ClinicalTrials.gov and may not reflect the sponsor's current status. Confirm during your call.