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

Duke University

Status: Completed

Conditions: Uterine Cancer

Treatments: Other: Transrectal ultrasound (TRUS)

Study type: Observational

Funder types: Other

Identifiers

NCT05977621

Pro00113768

Details and patient eligibility

About

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.

Enrollment: 8 patients

Sex: Female

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

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

Trial design

8 participants in 2 patient groups

Intact anatomy

Description:

Patients with intact anatomy (uterus and cervix)

Treatment:

Other: Transrectal ultrasound (TRUS)

Post-hysterectomy

Description:

Post-hysterectomy patients (vaginal cuff) who are planned to receive brachytherapy

Treatment:

Other: Transrectal ultrasound (TRUS)