Recruiting

Electromagnetic Navigation

Sponsor:

Sunnybrook Health Sciences Centre

Code:

NCT03781271

Conditions

Cervical Cancer

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

Interventions

Electromagnetic Navigation

Study Details

Brief summary:

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

Cervical Cancer

Study ID

NCT03781271

Start date

Oct 1, 2019

Status verified date

Mar, 2020

Completion date

Feb, 2021

Anticipated

Primary completion date

Oct, 2020

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: Female

Age: 0+

Healthy Volunteers: Not accepted

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

Study Design

Enrollment

10 participants

Anticipated

Allocation

Non randomized

Intervention Model

Crossover

Primary purpose

Device Feasibility

Interventions and Outcome Measures

Arms

experimental: Fraction 1-Addition of EMN

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.

experimental: Fraction 3-Addition of EMN

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.

Interventions

Electromagnetic Navigation

Electromagnetic navigation is a form of surgical navigation that can be incorporated into the cervical interstitial brachytherapy workflow to improve the current standards of guidance.

Primary outcome measure

  • Treatment Plan Target Volume and Organs at Risk Dosimetry [ Time Frame: 14 days ]

Central Contacts and Locations

Central contacts

Ananth Ravi, PhD

416 480 6100ananth.ravi@sunnybrook.ca

Locations

Sunnybrook Health Sciences Centre

Recruiting

Toronto, Ontario, Canada, M4N 3M5

More Information

Sponsor

Sunnybrook Health Sciences Centre

Last update posted

Mar 17, 2020

Last verified

Mar, 2020

Keywords

  • Interstitial Brachytherapy
  • Electromagnetic tracking
  • Implant quality
  • Image guidance

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Sunnybrook Health Sciences Centre on 2020-03-17.