Clinical trial · Interventional
Feasibility Study for Ultrasound-Guided Interstitial Brachytherapy for Gynecological CancersV2
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Brachytherapy treatment in gynecological cancers is an essential component to delivering adequate doses of radiation to a tumour while sparing normal tissue. Interstitial and intracavitary brachytherapy is often needed in advanced or recurrent disease, in cases where intrauterine brachytherapy may not deliver the optimal outcome. Interstitial brachytherapy is based on a defined template-and-needle system, and the procedure relies on clinical examination and pre-treatment imaging to guide needle insertion. There is currently no standard image-guided process to help direct needles in the pelvis. The investigators propose a 3D ultrasound device that will provide real-time imaging for the brachytherapy procedure which will aid in avoiding needle insertion into pelvic organs and result in optimal dose coverage to the tumour.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Gynecologic Cancer | Malignant Female Reproductive System Neoplasm | ALIAS | 0.90 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Interstitial and intracavitary brachytherapy | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- OTHER
- label
- Patient
- description
- Patients undergoing gynecological brachytherapy, will be imaged with a 3D ultrasound medical device for the purpose of efficacy testing.
- interventionNames
- Device: Interstitial and intracavitary brachytherapy
Primary outcomes (1)
- measure
- Efficacy of the 3DUS device to visualize applicators
- timeFrame
- 16 Weeks
- description
- The number of applicators identified within the 3D ultrasound image.
Secondary outcomes (1)
- measure
- 3DUS to CT Fusion
- timeFrame
- 16 Weeks
- description
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
Inclusion Criteria: * Patients with locally advanced or recurrent gynecological malignancies who are offered interstitial or intracavitary brachytherapy treatment. These typically would include patients with primary or recurrent vaginal cancers, endometrial cancers or cervical cancers. Histologies of these cancers are typically adenocarcinomas or squamous cell carcinomas Exclusion Criteria: * Above patients who are not offered interstitial or intracavitary brachytherapy as a treatment modality
References
Publications (3)
- RESULTRodgers JR, Hrinivich WT, Surry K, Velker V, D'Souza D, Fenster A. A semiautomatic segmentation method for interstitial needles in intraoperative 3D transvaginal ultrasound images for high-dose-rate gynecologic brachytherapy of vaginal tumors. Brachytherapy. 2020 Sep-Oct;19(5):659-668. doi: 10.1016/j.brachy.2020.05.006. Epub 2020 Jul 3. PMID 32631651
- RESULTRodgers JR, Bax J, Surry K, Velker V, Leung E, D'Souza D, Fenster A. Intraoperative 360-deg three-dimensional transvaginal ultrasound during needle insertions for high-dose-rate transperineal interstitial gynecologic brachytherapy of vaginal tumors. J Med Imaging (Bellingham). 2019 Apr;6(2):025001. doi: 10.1117/1.JMI.6.2.025001. Epub 2019 Apr 8. PMID 30989088
- RESULTRodgers JR, Mendez LC, Hoover DA, Bax J, D'Souza D, Fenster A. Feasibility of fusing three-dimensional transabdominal and transrectal ultrasound images for comprehensive intraoperative visualization of gynecologic brachytherapy applicators. Med Phys. 2021 Oct;48(10):5611-5623. doi: 10.1002/mp.15175. Epub 2021 Sep 2. PMID 34415069