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NCT05977621 | RECRUITING | Uterine Cancer


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

Duke University

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.

Condition or disease

Uterine Cancer

Intervention/treatment

Transrectal ultrasound (TRUS)

Study Type : OBSERVATIONAL
Estimated Enrollment : 7 participants
Official 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
Actual Study Start Date : 2024-02-07
Estimated Primary Completion Date : 2026-02
Estimated Study Completion Date : 2026-02

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 90 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
Criteria
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

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

Location Details

NCT05977621


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Locations


RECRUITING

United States, North Carolina

Duke Cancer Center

Durham, North Carolina, United States, 27710

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