Optimized Magnetic Resonance Brachytherapy (MR BT) in Cervix Cancer

October 18, 2022 updated by: University Health Network, Toronto

Implementation of Optimized Magnetic Resonance Image-guided Intra-uterine Brachytherapy in Cervical Cancer

Patients with cervix cancer usually require external radiation given to the whole pelvis then an internal radiation boost, also called brachytherapy, to treat any remaining tumour. Standard brachytherapy has been used successfully for many years, but does not take into account differences in the shape of the tumour or normal structures between patients. This study aims to implement individualized -optimized- brachytherapy, based on international recommendations. MR scanning with the intra-uterine applicator in place allows improved identification of residual tumour and normal structures, allowing brachytherapy to be individualized for each patient with the aim to reduce side-effects and improve outcome. Additionally, repeating MR scans during brachytherapy treatment will allow further assessment on motion of the applicator during treatment and the effect on radiation dose. Sexual health assessments aim to identify the relationship between sexual health and treatment effects.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Pre-treatment: Prior to examination under anaesthesia and placement of the intra-uterine applicator, in addition to standard assessment of treatment toxicity, the patient may complete an optional Sexual Health assessment taking approximately 15 minutes. Following standard insertion of the intra-uterine applicator under general anaesthetic and planning MRI scan, there is an optional additional MRI scan taking an extra 30 minutes This extra scan will not affect the commencement of treatment planning as images from the planning scan will be transferred to the treatment planning system as soon as they are obtained. From the MRi planning scan, target and specific normal structures are contoured. An individual BT plan will be derived based on a standard plan to deliver dose within specified dose volume constraints.

During treatment: During inpatient BT optional MRI scans, each taking 15 minutes will be obtained in the period between treatment pulses once during each 24 hours of admission. The information from the additional MRI scans will not be used to alter or influence treatment.

Follow-up: Standard follow-up procedures will be followed, with the optional addition of the Sexual Health evaluation at each visit.

Study Type

Interventional

Enrollment (Anticipated)

60

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Canada
    • Ontario
      • Toronto, Ontario, Canada, M5G 2M9
        • University Health Network

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

Inclusion Criteria:

  • Age over 18 years
  • ECOG performance status 0-2
  • Histological confirmed carcinoma cervix
  • Decision to treat with EBRT (+/- concurrent chemotherapy), and PDR BT
  • Ability to comply with study protocol
  • Patient informed consent

Exclusion Criteria:

  • Unable to or unwilling to give informed consent
  • Not suitable for intra-uterine brachytherapy
  • Previous treatment for pelvic malignancy
  • Previous pelvic radiotherapy
  • Serious claustrophobia
  • Previous history of metallic injury to the eye
  • Non-removable implants contraindicated for MRI
  • Cardiac pacemaker
  • Other contraindication to MRI -Pregnancy, lactation or child-bearing potential without adequate contraception -

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: (MR BT) in Cervix Cancer
Radiation: optimised magnetic resonance image-guided intra-uterine brachytherapy
Brachytherapy treatment will be planned based on the MRI test and will be individualized for each study participant,based on participant's cancer and body inside.Brachytherapy will be as an inpatient over 2-3 days. All other care will follow standard procedures.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Feasibility of clinical implementation of an effective and safe protocol for optimised MR image guided intra-uterine brachytherapy for cervix cancer.
Time Frame: 36 months
36 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Determine local control,overall survival,acute & late toxicity, & sexual health of patients treated with optimised intra-uterine BT. Evaluate stability of the intra-uterine applicator during BT. Evaluate dose homogeneity of BT for cervix cancer.
Time Frame: 36 months
36 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Health Network, Toronto

Collaborators

Princess Margaret Hospital, Canada

Investigators

  • Principal Investigator: Michael Milosevic, MD, University Health Network, Princess Margaret Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

May 1, 2008

Primary Completion (Actual)

January 1, 2017

Study Completion (Actual)

January 1, 2017

Study Registration Dates

First Submitted

July 10, 2009

First Submitted That Met QC Criteria

July 10, 2009

First Posted (Estimate)

July 13, 2009

Study Record Updates

Last Update Posted (Actual)

October 20, 2022

Last Update Submitted That Met QC Criteria

October 18, 2022

Last Verified

October 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • UHN REB 08-0206-C

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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