Using ultrasound for real-time imaging in uterine cancer treatment
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
This study is testing if combining ultrasound with MRI can help doctors place treatment needles more accurately for women with uterine cancer.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 17 (estimated) |
| Ages | 18 Years to 90 Years |
| Sex | Female |
| Sponsor | Duke University Academic / other |
| Drugs / interventions | chemotherapy, radiation |
| Locations | 1 site (Durham, North Carolina) |
| Trial ID | NCT05977621 on ClinicalTrials.gov |
What this trial studies
This study aims to explore the feasibility of using transrectal ultrasound (TRUS) images of the female pelvis to enhance a Magnetic Resonance Imaging (MRI)-TRUS fusion-based needle navigation system for image-guided brachytherapy in uterine cancer. The approach involves integrating TRUS with MRI to improve the precision of needle placement during treatment. The study will assess the effectiveness of this technology in both intact and post-hysterectomy patients, utilizing a proprietary 3D semi-robotic navigation system developed by Eigen Health.
Who should consider this trial
Good fit: Ideal candidates include adults aged 18 and older with histologically proven invasive uterine cancer who are undergoing curative-intent radiation treatment that includes brachytherapy.
Not a fit: Patients with active rectal bleeding or rectal ulcers may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could lead to more accurate and effective brachytherapy treatments for patients with uterine cancer.
How similar studies have performed: Other studies have shown success with similar MRI-ultrasound fusion techniques in prostate biopsies, suggesting potential for this approach in uterine cancer.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Durham, North Carolina
- Duke Cancer Center — Durham, North Carolina, United States (Recruiting)
Study contacts
- Principal investigator: Dianda Ayala-Peacock, MD — Duke University Health System (DUHS)
- Study coordinator: Kaitlin Bailey, BNS RN
- Email: Kaitlin.Bailey@duke.edu
- Phone: (919) 668-3726
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.