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ElectroMagnetic-guided Interstitial Catheter Navigation for Gynecological brachyTherapy (E-MINT)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03781271
Recruitment Status : Recruiting
First Posted : December 19, 2018
Last Update Posted : March 17, 2020
Sponsor:
Information provided by (Responsible Party):
Ananth Ravi, Sunnybrook Health Sciences Centre

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.

Condition or disease Intervention/treatment Phase
Cervical Cancer Device: Electromagnetic Navigation Not Applicable

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 10 participants
Allocation: Non-Randomized
Intervention Model: Crossover Assignment
Intervention Model Description: 2 arms of patients will undergo standard routine brachytherapy treatment. A part of the treatment involves the placement of catheters. For both arms of the study the placement of these catheters will be assisted by an electromagnetic navigation system. The difference between the arms will be that the navigation system will be used at different times in the course of their brachytherapy treatment to eliminate bias. One group will undergo electromagnetic navigation assisted catheter placement during their first fraction of treatment while the second arm will undergo electromagnetic navigation assisted catheter placement during their third fraction of treatment.
Masking: None (Open Label)
Primary Purpose: Device Feasibility
Official Title: ElectroMagnetic-guided Interstitial Catheter Navigation for Gynecological brachyTherapy: A Phase I Trial
Actual Study Start Date : October 1, 2019
Estimated Primary Completion Date : October 2020
Estimated Study Completion Date : February 2021

Arm Intervention/treatment
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.
Device: 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.

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.
Device: 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 Measures :
  1. Treatment Plan Target Volume and Organs at Risk Dosimetry [ Time Frame: 14 days ]
    The treatment plans generated during the course of treatment for participants will be evaluated. The evaluation of the treatment plans will use the dose received by specific target structures and the dose received by structures that are defined as organs at risk. The specific metric that will be used represents how much dose is received by a certain percentage of a volume. For example, the D98 GTV refers to how much dose is received by 98 percent of the gross tumour volume. The dose is a value that is measured in the unit, Gray. In addition to the dose constraint for the D98 GTV the other dose constraints that will be used for evaluation purposes are, D90 HR-CTV, D98 HR-CTV, D98 IR-CTV and OAR constraints. A significance level of 5% will be used to identify differences between the dose constraints for treatment plans that are generated when EMN is used and when EMN is not used.



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03781271


Contacts
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Contact: Ananth Ravi, PhD 416 480 6100 ext 1092 ananth.ravi@sunnybrook.ca

Locations
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Canada, Ontario
Sunnybrook Health Sciences Centre Recruiting
Toronto, Ontario, Canada, M4N 3M5
Contact: Ananth Ravi, PhD         
Sponsors and Collaborators
Sunnybrook Health Sciences Centre
Investigators
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Principal Investigator: Ananth Ravi, PhD Sunnybrook Health Sciences Centre
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Responsible Party: Ananth Ravi, Clinical Operations Lead of Brachytherapy, Sunnybrook Health Sciences Centre
ClinicalTrials.gov Identifier: NCT03781271    
Other Study ID Numbers: 143-2018
First Posted: December 19, 2018    Key Record Dates
Last Update Posted: March 17, 2020
Last Verified: March 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Results will be made available to relevant stakeholders within the Odette Cancer Centre as these results may assist in the translation of this trial into routine clinical practice.
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Time Frame: Data will be made available within 6 months of study completion.
Access Criteria: Data access requests external to the Odette Cancer Centre will be reviewed by the REB at Sunnybrook Health Science Centre prior to permitting access.

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ananth Ravi, Sunnybrook Health Sciences Centre:
Interstitial Brachytherapy
Electromagnetic tracking
Implant quality
Image guidance
Additional relevant MeSH terms:
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Uterine Cervical Neoplasms
Uterine Neoplasms
Genital Neoplasms, Female
Urogenital Neoplasms
Neoplasms by Site
Neoplasms
Uterine Cervical Diseases
Uterine Diseases