Clinical trial · Interventional
ElectroMagnetic-guided Interstitial Catheter Navigation for Gynecological brachyTherapy
ElectroMagnetic-guided Interstitial Catheter Navigation for Gynecological brachyTherapy: A Phase I Trial
- 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)
Phase I study evaluating the feasibility of using electromagnetic navigation (EMN) for the catheter implantation procedure required of cervical brachytherapy. The addition of EMN to the current HDR brachytherapy workflow has the potential to dramatically improve implant quality and efficiency for the gynecological interstitial brachytherapy program. Implant quality has been reported to be an important predictive factor for local control and late toxicity.
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 |
|---|---|---|---|
| Cervical Cancer | Malignant Cervical Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Electromagnetic Navigation | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- Fraction 1-Addition of EMN
- description
- During the fraction 1 insertion, the custom MRI-compatible vaginal cylinder will be placed in the patient, and will contain the 6 degree-of-freedom (DOF) sensor. The electromagnetic navigation system and computer will have been setup in the operating room (OR) prior to the procedure and will be used to actively insert up to 25 catheters into the target. The catheters will be inserted using a custom metallic stylet that has a custom 5-DOF sensor embedded in the tip for tracking its position in real-time. The physician may use ultrasound for assistance in target visualization as well. Catheter deflections will be detected and corrected for in real-time by the radiation oncologist as the catheter is inserted into the patient during the procedure, this will occur when the EM system is in use.
- interventionNames
- Device: Electromagnetic Navigation
- type
- EXPERIMENTAL
- label
- Fraction 3-Addition of EMN
- description
- For the second group of patients in the trial the same protocol will be followed as in the first group, the only difference will be that the electromagnetic navigation is used during the second implantation procedure immediately preceding fraction 3 as opposed to fraction 1, the time at which it was used for the first group of patients.
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
Inclusion Criteria: * Women diagnosed with FIGO stage IB2-IVA (locally advanced) cervical cancer being treated with combined 3D interstitial / intracavitary HDR brachytherapy in 4 fractions and concurrent chemotherapy * Minimum of 2 brachytherapy implantation procedures. * The Syed-Neblett applicator is indicated for use due to the extent/complexity of the disease * Given informed consent to take part in the study Exclusion Criteria: * Metastatic disease * Bilateral or unilateral hip prostheses * Pacemakers
References
Publications (0)
Data not yet available