Trans-Rectal Ultrasound of the Female Pelvis for Real-Time MRI-US Fusion Based Needle Tracking
((TRUS) Trial)
KB
JC
Overseen ByJoan Cahill, BNS OCN CCRP
Age: 18+
Sex: Female
Trial Phase: Academic
Sponsor: Duke University
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Trial Summary
What is the purpose of this trial?
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.
Research Team
DA
Dianda Ayala-Peacock, MD
Principal Investigator
Duke University Health System (DUHS)
Eligibility Criteria
Inclusion Criteria
You have a histologically confirmed diagnosis of invasive squamous, adenosquamous or adenocarcinoma cancer originating in the uterine cervix that is recurrent or medically inoperable and an adenocarcinoma originating from the uterus.
You have an ECOG Performance Status of 0-2.
Radiation therapy with brachytherapy treatments, potentially in conjunction with chemotherapy, must be implemented as part of the treatment plan.
Treatment Details
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Post-hysterectomyExperimental Treatment1 Intervention
Post-hysterectomy patients (vaginal cuff) who are planned to receive brachytherapy
Group II: Intact anatomyExperimental Treatment1 Intervention
Patients with intact anatomy (uterus and cervix)
Find a Clinic Near You
Who Is Running the Clinical Trial?
Duke University
Lead Sponsor
Trials
2,495
Recruited
5,912,000+
Eigen
Collaborator
Trials
3
Recruited
560+
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