Trans-Rectal Ultrasound of the Female Pelvis for Real-Time MRI-US Fusion Based Needle Tracking
ConditionUterine Cancer
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexFemale
Age18-90
SponsorDuke University
About 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.
Eligibility criteria
Qualifiers
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
Disqualifiers
Patients with active rectal bleeding or rectal ulcer
Trial design
Treatments tested in this trial
- Transrectal ultrasound (TRUS)
Treatment groups
17 Participants
are divided into 2 treatment groupsSponsors and collaborators
Duke University
Lead sponsor
Eigen
Collaborator
Source ClinicalTrials.gov