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

Phase

N/A

Condition

Endometrial Cancer

Vaginal Cancer

Uterine Fibroids

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