Trans-Rectal Ultrasound of the Female Pelvis for Real-Time MRI-US Fusion Based Needle Tracking
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Transrectal ultrasound (TRUS).
- Who it may be relevant to
- Registry conditions: Uterine Cancer. Basic parameters: 18 years — 90 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- United States
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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.
Interventions
- Other Transrectal ultrasound (TRUS)
Transrectal ultrasound (TRUS) images of the female pelvis
Primary outcome measures
- Number of patients whose MRI and ultrasound images are fused [Time frame: up to 5 weeks]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Case-only
Study locations
United States · 1 center
- Duke Cancer Center — Durham
Identifiers
NCT: NCT05977621 · Pro00113768