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

This trial does not accept healthy volunteers

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 population

Patients who are undergoing brachytherapy as part of the standard plan for their gynecologic cancer diagnosis (defined above) will be our target population. Only women will be eligible for this study. Women of all races/ethnicities will be eligible, and accrual is expected to reflect the population of patients seen in the Duke Radiation Oncology Clinic.

Trial design

Design model

Case-only

Time perspective

Prospective

Treatments tested in this trial

Transrectal ultrasound (TRUS)
Other intervention
Transrectal ultrasound (TRUS) images of the female pelvis

Treatment groups

17 Participants

are divided into 2 treatment groups

Group A: Intact anatomy1 intervention

Group B: Post-hysterectomy1 intervention

Trial outcomes

Primary outcomes

Number of patients whose MRI and ultrasound images are fused

Time frame

up to 5 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Duke University

Lead sponsor

Eigen

Collaborator

Source ClinicalTrials.gov

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