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

February 9, 2024 updated by: Duke University

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

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

7

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • United States
    • North Carolina
      • Durham, North Carolina, United States, 27710
        • Recruiting
        • Duke Cancer Center
        • Contact:
        • Contact:
        • Principal Investigator:
          • Diandra Ayala-Peacock, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

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.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Number of patients whose MRI and ultrasound images are fused
Time Frame: up to 5 weeks
up to 5 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Duke University

Collaborators

Eigen

Investigators

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

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 7, 2024

Primary Completion (Estimated)

February 1, 2025

Study Completion (Estimated)

February 1, 2025

Study Registration Dates

First Submitted

July 28, 2023

First Submitted That Met QC Criteria

July 28, 2023

First Posted (Actual)

August 4, 2023

Study Record Updates

Last Update Posted (Actual)

February 12, 2024

Last Update Submitted That Met QC Criteria

February 9, 2024

Last Verified

February 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Pro00113768

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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