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

The use of MRI in radiotherapy planning to assess the feasibility of adaptive radiotherapy in gynaecological cancers.

Status

Completed

Phases

Unknown

Study type

Observational

Source

ANZCTR

Registry ID

ACTRN12615000862549

Acronym

Gynae MRI study

Enrollment

Registered

2015-08-18

Start date

2014-07-23

Completion date

2017-04-13

Last updated

2024-09-09

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

The objective of this project is to develop methods to allow adaptive radiotherapy for cervical and other gynaecological cancers. Adaptive radiotherapy refers to incorporating patient specific changes over time to tailor the delivery of radiotherapy throughout the course of treatment. Who is it for? You may be eligible to join this study if you are aged 18 years or older, and have been diagnosed with a gynaecological cancer for which you have been recommended radiotherapy to the pelvis. Study details Participants will undergo usual radiotherapy treatment, with additional Magnetic Resonance Imaging (MRI) scans taken just prior to beginning treatment, and weekly during radiotherapy treatment until a maximum of 6 scans have been taken. The results of these scans will not alter the treatment received by participants. Data will be used to aid development of new radiotherapy treatment protocols. It is hoped that the findings of this study will lead to the development of the technical requirements required to implement adaptive radiotherapy using MRI. The potential benefit of this is to improve outcomes for women with gynaecological cancers, and reduce the rates of side effects from treatment.

Interventions

The study design is a prospective cohort study. Patients will receive standard treatment for their malignancy, this study does not involve a treatment intervention. Participants will be undergoing standard radiotherapy treatment. Each patient will have an MRI prior to treatment (planning MRI) and weekly MRIs during the course of treatment, to a maximum of 6 MRIs per patient. The weekly MRIs are additional to what is usually received as standard of care. Each MRI scan will take approximately 30 minutes. The additional MRI scans will be de-identified and study co-investigators will outline normal tissues and the tumour. This information will then be used to develop software that will facilitate the adaptive radiotherapy workflow which will potentially reduce radiation dose to surrounding normal tissues and allow dose escalation (increase in dose delivered to the tumour).

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Healthy volunteers

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

Outcome results