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NCT Number: NCT05977621

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

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.

Recruiting

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Key information

Conditions

Uterine Cancer Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Genital Neoplasms, Female Neoplasms Neoplasms by Site Urogenital Diseases Urogenital Neoplasms Uterine Diseases Uterine Neoplasms

Age range

18 year–90 year

Sex eligibility

Female

Study type

Observational

Primary location

Duke Cancer Center

Durham, North Carolina, 27710, United States

Location status: Recruiting

Location contact

Diandra Ayala-Peacock, MD

PRINCIPAL_INVESTIGATOR

Kaitlin Bailey, RN

CONTACT

[email protected]

919-668-3726

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Transrectal ultrasound (TRUS)

Other

Transrectal ultrasound (TRUS) images of the female pelvis

Primary outcomes

  1. Number of patients whose MRI and ultrasound images are fused

    Time frame: up to 5 weeks

Study contacts

Contact information is provided by the study sponsor or research team.

Kaitlin Bailey, BNS RN

CONTACT

[email protected]

(919) 668-3726

Sponsors and collaborators

Lead sponsor

Duke University

Other

Collaborators

  • Eigen

Registry information

Official study title

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

Acronym: (TRUS)

Important dates

Study start
2024
Primary completion
2027
Study completion
2027
First posted
Aug 4, 2023
Registry last updated
Mar 6, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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