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A pilot study involving pre-surgery breast Magnetic resonance Imaging (MRI) for target volume delineation for breast- conserving radiation therapy

Pre-surgery MRI for target volume delineation in breast-conserving therapy: A pilot study

Status
Terminated
Phases
Phase 2
Study type
Interventional
Source
ANZCTR
Registry ID
ACTRN12616000841471
Acronym
Pre-Surgery Breast MRI
Enrollment
6
Registered
2016-06-28
Start date
2016-05-09
Completion date
2017-09-05
Last updated
2020-01-13

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

Conditions

None listed

Brief summary

This study aims to provide proof of principle for the use of pre-surgery breast MRI to guide radiation oncologists in determining radiotherapy treatment volumes. Who is it for? You may be eligible to join this study if you are a female aged 18 years or more and have an early stage breast cancer and are scheduled to undergo breast conserving surgery at Liverpool Hospital, NSW. Study details The study will involve participants completing MRI scans in the supine and prone positions and as per their routine care, will also undergo routine radiotherapy planning CT scans. These scans will be performed before surgery, after surgery and before radiotherapy for patients that are also receiving chemotherapy treatment. These images will be used to compare treatment volumes used to determine where the radiation is delivered generated based on the MRI information and based on the standard of care the CT information. Standard practice will be used for treatment, that is treatment volumes will be based on CT with no change in standard practice. It is hoped that this study will provide a proof of principle that pre-surgery MRI can be used to guide radiation oncologists in determining radiotherapy treatment volumes.

Interventions

The intervention involved in this study is the introduction of a pre-surgery breast MRI as comparison to the standard of no pre-surgery imaging to guide radiation oncologists in determining radiotherapy treatment volumes. Currently the standard of care is to use CT images. This study will compare the use of MRI with this standard of CT. Patient treatment will still be based on the CT images and there will be no changes to the standard treatment practice. The MRIs will be undertaken on two occasi

The intervention involved in this study is the introduction of a pre-surgery breast MRI as comparison to the standard of no pre-surgery imaging to guide radiation oncologists in determining radiotherapy treatment volumes. Currently the standard of care is to use CT images. This study will compare the use of MRI with this standard of CT. Patient treatment will still be based on the CT images and there will be no changes to the standard treatment practice. The MRIs will be undertaken on two occasions if the participant is not having chemotherapy (within approximately one week prior to surgery and then at the same time as planning imaging for radiotherapy treatment) as part of their standard treatment or three times if the participant is having chemotherapy (within approximately one week prior to surgery, within approximately one week post-surgery and then at the same time as planning imaging for radiotherapy treatment). Two MRI scans will be performed on each occasion with the participant lying on their back (supine) for one scan then lying on their front (prone) for the other scan. The MRI scan will take approximately 60 minutes. Contrast will only be administered for the pre-surgery prone scan. The MRIs will be undertaken by clinical MRI and radiotherapy staff with expertise required for clinical use of this imaging modality. Definition of the target volumes on the MRIs will be undertaken by radiation oncologists, radiologists and radiation therapists familiar with breast cancer treatment volumes. These images will not be used for clinical treatment planning during the course of this study.

Sponsors

Lois Holloway
Lead SponsorIndividual

Study design

Allocation
Non-randomised trial
Intervention model
Single group
Primary purpose
Treatment
Masking
Open (masking not used)

Eligibility

Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No

Inclusion criteria

Aged 18 years or older Clinical T1-T2, N0 staged breast cancer Scheduled for breast conserving surgery

Exclusion criteria

History of ipsilateral breast cancer Contra-indications for MRI e.g. ferromagnetic materials within the patient, claustrophobia Receiving neoadjuvant treatment

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026