Developing methods to allow adaptive radiotherapy for gynaecological cancers with Magnetic Resonance Imaging (MRI)

Not Applicable

Completed

• Conditions: Gynaecological Cancer; Cancer - Cervical (cervix); Cancer - Womb (Uterine or endometrial cancer); Cancer - Other cancer types

• Registration Number: ACTRN12615000862549
• Lead Sponsor: Dr Karen Lim

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2015-08-18
• Study Completion: 2019-09-08
• Last Update Posted: 9 September 2024

Recruitment & Eligibility

• Status: Completed
• Sex: Female
• Target Recruitment: 32

Inclusion Criteria

Eligible patients will have a gynaecological cancer for which they have been recommended a course of radiotherapy to the pelvis, in addition to:
1. Aged older than 18 years
2. ECOG 0-3
3. Histological diagnosis of malignant gynaecological tumour, including
a. Squamous cell carcinoma
b. Adenocarcinoma
c. Adenosquamous cell carcinoma
d. Endometrial carcinoma
e. Melanoma
f. Malignant mesenchymal tumours
g. Undifferentiated carcinomas
4. Written informed consent

Exclusion Criteria

1. Contraindication for MRI
a. Cardiac pacemaker or defibrillator
b. Non MRI compatible implants
i.Metal rod, screw or plate
ii Aneurysm clip
iii Artificial heart valve
iv Cochlear implant
v Intravascular stent
c. Non-MRI compatible metallic foreign body
i Metallic fragment in the eye
ii Bullet or shrapnel injury
d. Severe claustrophobia
2. Prior hysterectomy
3. Women who are pregnant and the human foetus
4. Children and/or young people (ie. <18 years)
5. People with an intellectual or mental impairment
6. People highly dependent on medical care

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Development of gold-standard contours using STAPLE algorithm[ From time of last MRI to time that contours are finalised and analysed];Accuracy of autogenerated vs gold-standard contours through assessment of variability between contours computed using several metrics, including dice similarity co-efficient (DSC), Hausdorff distance, and average surface distance. [ From time of last MRI to time that contours are finalised and analysed];Development of atlas of the female pelvis using a series of MRI and CT images[ From time of last MRI to time that contours are finalised and analysed]

Secondary Outcome Measures

Name	Time	Method
Accuracy of MRI based radiotherapy dose calculations assessed by comparison to current gold-standard dose calculations. [ Assessed by comparison to CT based dose calculations following completion of planning of all patients ];Generation of advanced MRI sequence database through compilation of all MRI study data and comparison of advanced MR sequences to standard MR sequences.[ From time of last MRI to time that contours are finalised and analysed];Primary outcome - Development of autogenerated contours using an automated algorithm for cervix contours using atlas-based deformable image registration [ From time of last MRI to time that contours are finalised and analysed];Primary Outcome - Time taken to create autogenerated vs gold-standard contours [ From time of last MRI to time that contours are finalised and analysed]