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

NCT ID: NCT05977621

Last Updated: 2025-12-17

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

ACTIVE_NOT_RECRUITING

Total Enrollment

7 participants

Study Classification

OBSERVATIONAL

Study Start Date

2024-02-07

Study Completion Date

2025-12-11

Brief Summary

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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.

Detailed Description

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Conditions

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Uterine Cancer

Study Design

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Observational Model Type

CASE_ONLY

Study Time Perspective

PROSPECTIVE

Study Groups

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Intact anatomy

Patients with intact anatomy (uterus and cervix)

Transrectal ultrasound (TRUS)

Intervention Type OTHER

Transrectal ultrasound (TRUS) images of the female pelvis

Post-hysterectomy

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

Transrectal ultrasound (TRUS)

Intervention Type OTHER

Transrectal ultrasound (TRUS) images of the female pelvis

Interventions

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Transrectal ultrasound (TRUS)

Transrectal ultrasound (TRUS) images of the female pelvis

Intervention Type OTHER

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Eigen

OTHER

Sponsor Role collaborator

Duke University

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Dianda Ayala-Peacock, MD

Role: PRINCIPAL_INVESTIGATOR

Duke University Health System (DUHS)

Locations

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Duke Cancer Center

Durham, North Carolina, United States

Site Status

Countries

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United States

Other Identifiers

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Pro00113768

Identifier Type: -

Identifier Source: org_study_id