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

Sponsor

Duke University (Other)

Overall Status

Not yet recruiting

CT.gov ID

NCT05977621

Collaborator

Eigen (Other)

Enrollment

Location

Anticipated Duration (Months)

0.6

Patients Per Site Per Month

Study Details

Study Description

Brief 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.

Condition or Disease	Intervention/Treatment	Phase
Uterine Cancer	Other: Transrectal ultrasound (TRUS)

Study Design

Study Type:

Observational

Anticipated Enrollment :

7 participants

Observational Model:

Case-Only

Time Perspective:

Prospective

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

Anticipated Study Start Date :

Sep 1, 2023

Anticipated Primary Completion Date :

Sep 1, 2024

Anticipated Study Completion Date :

Sep 1, 2024

Arms and Interventions

Arm	Intervention/Treatment
Intact anatomy Patients with intact anatomy (uterus and cervix)	Other: Transrectal ultrasound (TRUS) Transrectal ultrasound (TRUS) images of the female pelvis
Post-hysterectomy Post-hysterectomy patients (vaginal cuff) who are planned to receive brachytherapy	Other: Transrectal ultrasound (TRUS) Transrectal ultrasound (TRUS) images of the female pelvis

Arm

Intervention/Treatment

Intact anatomy

Patients with intact anatomy (uterus and cervix)

Other: Transrectal ultrasound (TRUS)

Transrectal ultrasound (TRUS) images of the female pelvis

Post-hysterectomy

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

Other: Transrectal ultrasound (TRUS)

Transrectal ultrasound (TRUS) images of the female pelvis

Outcome Measures

Primary Outcome Measures

Number of patients whose MRI and ultrasound images are fused [up to 5 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 90 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Duke Cancer Center	Durham	North Carolina	United States	27710

Sponsors and Collaborators

Duke University
Eigen

Investigators

Principal Investigator: Dianda Ayala-Peacock, MD, Duke University Health System (DUHS)

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Duke University

ClinicalTrials.gov Identifier:

NCT05977621

Other Study ID Numbers:

Pro00113768

First Posted:

Aug 4, 2023

Last Update Posted:

Aug 4, 2023

Last Verified:

Jul 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Uterine Neoplasms

Study Results

No Results Posted as of Aug 4, 2023