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
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.
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Feasibility of clinical implementation of an effective and safe protocol for optimised MR image guided intra-uterine brachytherapy for cervix cancer.
Michael Milosevic, MD
University Health Network, Princess Margaret Hospital
Canada: Ethics Review Committee
UHN REB 08-0206-C