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

NCT05977621 | Recruiting

• 1 other identifier: Pro00113768
• Study Type: observational
• Target: 17
• Locations: 1 country
• Sites: 1

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.

Conditions

Uterine Cancer

Outcome Measures

Primary Outcomes (1)

• Number of patients whose MRI and ultrasound images are fused

  up to 5 weeks

Study Arms (2)

Intact anatomy

Patients with intact anatomy (uterus and cervix)

Other: Transrectal ultrasound (TRUS)

Post-hysterectomy

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

Other: Transrectal ultrasound (TRUS)

Interventions

Transrectal ultrasound (TRUS) OTHER

Transrectal ultrasound (TRUS) images of the female pelvis

Intact anatomy; Post-hysterectomy

Eligibility Criteria

• Age: 18 Years - 90 Years
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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.

You may qualify if:

• 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

You may not qualify if:

• Patients with active rectal bleeding or rectal ulcer

Sponsors & Collaborators

• Duke University: lead
• Eigen: collaborator

Study Sites (1)

Duke Cancer Center

Durham, North Carolina, 27710, United States

RECRUITING

MeSH Terms

Conditions

Uterine Neoplasms

Interventions

Ultrasound, High-Intensity Focused, Transrectal

Condition Hierarchy (Ancestors)

Genital Neoplasms, Female; Urogenital Neoplasms; Neoplasms by Site; Neoplasms; Uterine Diseases; Genital Diseases, Female; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Genital Diseases

Intervention Hierarchy (Ancestors)

High-Intensity Focused Ultrasound Ablation; Ultrasonic Therapy; Diathermy; Hyperthermia, Induced; Therapeutics; Ablation Techniques; Surgical Procedures, Operative; Prostatectomy; Urologic Surgical Procedures, Male; Urologic Surgical Procedures; Urogenital Surgical Procedures

Study Officials

• Dianda Ayala-Peacock, MD

  Duke University Health System (DUHS)

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Kaitlin Bailey, BNS RN

CONTACT

(919) 668-3726; Kaitlin.Bailey@duke.edu

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 28, 2023
• First Posted: August 4, 2023
• Study Start: February 7, 2024
• Primary Completion (Estimated): March 1, 2027
• Study Completion (Estimated): March 1, 2027
• Last Updated: March 6, 2026

Record last verified: 2026-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)