Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Eigen | OTHER |
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intact anatomy | Patients with intact anatomy (uterus and cervix) |
| |
| Post-hysterectomy | Post-hysterectomy patients (vaginal cuff) who are planned to receive brachytherapy |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Transrectal ultrasound (TRUS) | Other | Transrectal ultrasound (TRUS) images of the female pelvis |
|
| Measure | Description | Time Frame |
|---|---|---|
| Number of patients whose MRI and ultrasound images are fused | up to 5 weeks |
Not provided
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
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.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kaitlin Bailey, BNS RN | Contact | (919) 668-3726 | Kaitlin.Bailey@duke.edu |
| Name | Affiliation | Role |
|---|---|---|
| Dianda Ayala-Peacock, MD | Duke University Health System (DUHS) | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Duke Cancer Center | Recruiting | Durham | North Carolina | 27710 | United States |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Term |
|---|---|
| D014594 | Uterine Neoplasms |
| ID | Term |
|---|---|
| D005833 | Genital Neoplasms, Female |
| D014565 | Urogenital Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
Not provided
Not provided
| ID | Term |
|---|---|
| D036761 | Ultrasound, High-Intensity Focused, Transrectal |
| ID | Term |
|---|---|
| D057086 | High-Intensity Focused Ultrasound Ablation |
| D014464 | Ultrasonic Therapy |
| D003972 | Diathermy |
| D006979 | Hyperthermia, Induced |
Not provided
Not provided
Not provided
Not provided
Not provided
| D014591 |
| Uterine Diseases |
| D005831 | Genital Diseases, Female |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D000091662 | Genital Diseases |
| D013812 | Therapeutics |
| D055011 | Ablation Techniques |
| D013514 | Surgical Procedures, Operative |
| D011468 | Prostatectomy |
| D013521 | Urologic Surgical Procedures, Male |
| D013520 | Urologic Surgical Procedures |
| D013519 | Urogenital Surgical Procedures |