Uterine Cancer(TRUS)NCT05977621
Trans-Rectal Ultrasound of the Female Pelvis for Real-Time MRI-US Fusion Based Needle Tracking
An observational study of Uterine Cancer, run by Duke University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 90 years, women only
- Conditions the study is for
- Uterine Cancer
- What is being tested?
- Transrectal ultrasound (TRUS)
- How many people
- 17 participants
- Where
- 1 siteUnited States
- Study dates
- 7 Feb 2024to Mar 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- Women only
- No healthy volunteers
- Adult, Older adult
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.
Who may be able to join
- 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
Who cannot join
- Patients with active rectal bleeding or rectal ulcer
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Duke Cancer Center
Durham, North Carolina, 27710
Kaitlin Bailey, RN, 919-668-3726, Kaitlin.Bailey@duke.edu
Diandra Ayala-Peacock, MD
About this study
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
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
- Being tested
- Transrectal ultrasound (TRUS)
- Medical subject headings
- Uterine Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Transrectal ultrasound (TRUS)Other
Transrectal ultrasound (TRUS) images of the female pelvis
| Study group | Role | What they receive |
|---|---|---|
| Intact anatomy | Patients with intact anatomy (uterus and cervix) Receives: Other: Transrectal ultrasound (TRUS) | |
| Post-hysterectomy | Post-hysterectomy patients (vaginal cuff) who are planned to receive brachytherapy Receives: Other: Transrectal ultrasound (TRUS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Number of patients whose MRI and ultrasound images are fused
Measured: up to 5 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2023
- Study start7 Feb 2024
- Primary completionMar 2027 (estimated)
- Study completionMar 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Uterine CancerStudies of the same condition, open and under way.
- More trials run by Duke UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case only
- Time perspective
- Prospective
- Enrolment
- 17 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Duke University
- Sponsor type
- University, hospital or other
- Collaborators
- Eigen
- Responsible party
- Sponsor
- Investigators
- Dianda Ayala-Peacock, MD, Principal investigator, Duke University Health System (DUHS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05977621
- Sponsor's protocol ID
- Pro00113768
- Acronym
- (TRUS)
- Status last verified
- Feb 2026
- First submitted
- 28 Jul 2023
- Last updated
- 6 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 6 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT05977621
- Acronym / sponsor ID
- (TRUS) / Pro00113768
- Conditions
- Uterine Cancer
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 17 participants (estimated)
- Lead sponsor
- Duke UniversityUniversity, hospital or other
- Collaborators
- Eigen
- Study start
- 7 Feb 2024 (actual)
- Primary completion
- Mar 2027 (estimated)
- Study completion
- Mar 2027 (estimated)
- First posted
- 4 Aug 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intact anatomy | – | Other: Transrectal ultrasound (TRUS)Patients with intact anatomy (uterus and cervix) |
| Post-hysterectomy | – | Other: Transrectal ultrasound (TRUS)Post-hysterectomy patients (vaginal cuff) who are planned to receive brachytherapy |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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.
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (1 listed)
- Patients with active rectal bleeding or rectal ulcer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Transrectal ultrasound (TRUS)Transrectal ultrasound (TRUS) images of the female pelvis | Other | Intact anatomy, Post-hysterectomy |
Primary outcome
Number of patients whose MRI and ultrasound images are fused
Time frame: up to 5 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Mar 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Dianda Ayala-Peacock, MD principal investigator
Duke University Health System (DUHS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Uterine Cancer, run by Duke University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 1 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 6 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Kaitlin Bailey, BNS RN ((919) 668-3726, Kaitlin.Bailey@duke.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Number of patients whose MRI and ultrasound images are fused (time frame: up to 5 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Mar 2026.