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NCT05977621 Clinical Trial

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

Uterine Cancer Clinical Trial

— (TRUS)  

Official title:
Acquisition of Trans-Rectal Ultrasound [TRUS] Images of the Female Pelvis for Real-Time MRI-US Fusion Based Needle Tracking for Image-Guided Brachytherapy: A Pre-feasibility Study

Clinical Trial Details — Status: Recruiting

Administrative data
NCT number NCT05977621
Other study ID # Pro00113768
Secondary ID
Status Recruiting
Phase
First received
Last updated
Start date February 7, 2024
Est. completion date February 2025

Study information
Verified date February 2024
Source Duke University
Contact Kaitlin Bailey, BNS RN
Phone (919) 668-3726
Email Kaitlin.Bailey@duke.edu
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Recruiting
Enrollment 7
Est. completion date February 2025
Est. primary completion date February 2025
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 90 Years
Eligibility 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

Related Conditions & MeSH terms

Intervention

Other:
• Transrectal ultrasound (TRUS)
Transrectal ultrasound (TRUS) images of the female pelvis

Locations
Country Name City State
United States Duke Cancer Center Durham North Carolina

Sponsors (2)
Lead Sponsor Collaborator
Duke University Eigen

Country where clinical trial is conducted

United States, 

Outcome
Type Measure Description Time frame Safety issue
Primary Number of patients whose MRI and ultrasound images are fused up to 5 weeks
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