Trans-Rectal Ultrasound of the Female Pelvis for Real-Time MRI-US Fusion Based Needle Tracking
Recruiting
- Conditions
- Uterine Cancer
- Interventions
- Other: Transrectal ultrasound (TRUS)
- Registration Number
- NCT05977621
- Lead 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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- RECRUITING
- Sex
- Female
- Target Recruitment
- 7
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
Study & Design
- Study Type
- OBSERVATIONAL
- Study Design
- Not specified
- Arm && Interventions
Group Intervention Description Intact anatomy Transrectal ultrasound (TRUS) Patients with intact anatomy (uterus and cervix) Post-hysterectomy Transrectal ultrasound (TRUS) Post-hysterectomy patients (vaginal cuff) who are planned to receive brachytherapy
- Primary Outcome Measures
Name Time Method Number of patients whose MRI and ultrasound images are fused up to 5 weeks
- Secondary Outcome Measures
Name Time Method
Trial Locations
- Locations (1)
Duke Cancer Center
🇺🇸Durham, North Carolina, United States