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

Phase 2
18 Years
Open (Enrolling)
Cervix Cancer

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Trial Information

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

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

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

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 -

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Feasibility of clinical implementation of an effective and safe protocol for optimised MR image guided intra-uterine brachytherapy for cervix cancer.

Outcome Time Frame:

36 months

Safety Issue:


Principal Investigator

Michael Milosevic, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

University Health Network, Princess Margaret Hospital


Canada: Ethics Review Committee

Study ID:

UHN REB 08-0206-C



Start Date:

May 2008

Completion Date:

May 2015

Related Keywords:

  • Cervix Cancer
  • Intra-uterine Brachytherapy
  • cervix cancer
  • Patients suitable for intra-uterine brachytherapy for invasive carcinoma of the cervix.
  • Uterine Cervical Neoplasms