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Trial Title:
Trans-Rectal Ultrasound of the Female Pelvis for Real-Time MRI-US Fusion Based Needle Tracking
NCT ID:
NCT05977621
Condition:
Uterine Cancer
Conditions: Official terms:
Uterine Neoplasms
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Prospective
Intervention:
Intervention type:
Other
Intervention name:
Transrectal ultrasound (TRUS)
Description:
Transrectal ultrasound (TRUS) images of the female pelvis
Arm group label:
Intact anatomy
Arm group label:
Post-hysterectomy
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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
Gender:
Female
Gender based:
Yes
Minimum age:
18 Years
Maximum age:
90 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
Duke Cancer Center
Address:
City:
Durham
Zip:
27710
Country:
United States
Status:
Recruiting
Contact:
Last name:
Kaitlin Bailey, RN
Phone:
919-668-3726
Email:
Kaitlin.Bailey@duke.edu
Contact backup:
Last name:
Joan Cahill, BSN OCN CCRP
Phone:
(919) 668-5211
Email:
Joan.Cahill@duke.edu
Investigator:
Last name:
Diandra Ayala-Peacock, MD
Email:
Principal Investigator
Start date:
February 7, 2024
Completion date:
February 2025
Lead sponsor:
Agency:
Duke University
Agency class:
Other
Collaborator:
Agency:
Eigen
Agency class:
Other
Source:
Duke University
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05977621
