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

Last updated: January 3, 2025
Sponsor: Duke University
Overall Status: Active - Recruiting

Phase

N/A

Condition

Uterine Cancer

Pelvic Cancer

Endometrial Cancer

Treatment

Transrectal ultrasound (TRUS)

Clinical Study ID

NCT05977621
Pro00113768
  • Ages 18-90
  • Female

Study 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 Criteria

Inclusion

Inclusion Criteria:

  • Histologically proven invasive primary squamous, adenosquamous, or adenocarcinoma ofthe uterine cervix, (recurrent or medically inoperable) uterine adenocarcinoma.

  • Treatment plan must include curative-intent definitive radiation that includesbrachytherapy treatments with or without concurrent chemotherapy

  • Adults ≥ 18 years of age

  • ECOG Performance Status 0-2

Exclusion

Exclusion Criteria:

  • Patients with active rectal bleeding or rectal ulcer

Study Design

Total Participants: 7
Treatment Group(s): 1
Primary Treatment: Transrectal ultrasound (TRUS)
Phase:
Study Start date:
February 07, 2024
Estimated Completion Date:
February 28, 2026

Connect with a study center

  • Duke Cancer Center

    Durham, North Carolina 27710
    United States

    Active - Recruiting

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