RecruitingNCT05977621

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


Sponsor

Duke University

Enrollment

17 participants

Start Date

Feb 7, 2024

Study Type

OBSERVATIONAL

Conditions

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.


Eligibility

Sex: FEMALEMin Age: 18 YearsMax Age: 90 Years

Inclusion Criteria4

  • 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 Criteria1

  • Patients with active rectal bleeding or rectal ulcer

Interventions

OTHERTransrectal ultrasound (TRUS)

Transrectal ultrasound (TRUS) images of the female pelvis


Locations(1)

Duke Cancer Center

Durham, North Carolina, United States

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NCT05977621


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