None listed
Conditions
Brief summary
This study aims to find out if having a breast MRI after being diagnosed with breast cancer might change plans for treating the breast cancer and how this might affect patient outcomes. Who is it for? This study may be suitable if you are 18 years or older, have been recently diagnosed with breast cancer and your medical team has suggested that having a breast MRI will help plan your treatment. Trial Details Participants will not need any extra or different procedures or treatments over and above the normal care which has been offered to them by their treatment team. The research team will: * Collect information to be used in the study about participants' cancer, imaging and other tests, and their treatment. * Access clinical information collected during participants' appointments with their doctor about their current cancer care and follow up. * Access participants' clinical data from other health services used or attended as part of their cancer care (e.g. radiology or surgery). This information will be collected for up to 2 years after participant registration to the study. Participants will also be asked to complete some questionnaires to help the researchers understand how the decisions about their treatment based on having an MRI have impacted on them and their lives: * At the start of the study (before MRI): Their preference for surgery/treatment, how much uncertainty they have about making decisions, and their general wellbeing (approximately 10 minutes). * After MRI : Their preference for surgery/treatment, how much uncertainty they have about making decisions, their general well-being, and the impact of the MRI on their confidence in their treatment decision (approximately 5 minutes). * After initial treatment: Their general well-being, impact of MRI on confidence in decision (approximately 5 minutes). * 12 months after registration: Their general well-being, the impact of the MRI on their confidence in their treatment decision and their satisfaction about their decision (approximately 10 minutes). It is hoped that this research will lead to the introduction of MRI as a routine method for diagnosis and informing treatment planning for women diagnosed with breast cancer in the future.
Interventions
Participants diagnosed with early breast cancer whose medical team suggests that they have an MRI will be followed to determine if having an MRI changes their treatment plan and how this affects cancer outcomes.
This research does not involve any interventional treatment and will not be altering patient treatments or outcomes. This an observational study in which the researchers take note of information collected during standard care and treatment and from the questionnaires participants are as
Participants diagnosed with early breast cancer whose medical team suggests that they have an MRI will be followed to determine if having an MRI changes their treatment plan and how this affects cancer outcomes. This research does not involve any interventional treatment and will not be altering patient treatments or outcomes. This an observational study in which the researchers take note of information collected during standard care and treatment and from the questionnaires participants are asked to complete about how how they feel during treatment planning and care. Participants will not need any extra or different procedures or treatments beyond the normal care offered by their treatment team. The study involves researchers: * Collecting information about participants' cancer, scans and other tests, and their treatment. * Accessing clinical information collected during participants' appointments with their doctor about their current cancer care and follow up. * Accessing participants' clinical data from other health services used or attended as part of their cancer care (e.g. radiology or surgery). This information will be collected for up to 2 years after registration to the study. Participants will also be asked to complete questionnaires on their decisions about their treatment and how this may have impacted on their lives. The questionnaires will take approximately 10 minutes to complete at 4 different times: * At the start of the study (before MRI) * After MRI * After initial treatment * 12 months after registration.
Sponsors
Breast Cancer Trials
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
For inclusion in the study, participants must fulfil all the following criteria: 1) Provide written, informed consent to participate in the study. 2) Female >= 18 years with newly diagnosed early or locally advanced breast cancer for local staging and: a. With ultrasound/mammography, clinical examination results that are discrepant with respect to surgical and other treatment planning; AND/OR b. < 70 years with invasive lobular cancer; AND/OR c. < 50 years; AND/OR d. With reported extreme breast density on mammogram (as defined by the local site); AND/OR e. Breast diagnostic team suggests MRI may contribute to management. 3) Must have had pre-MRI treatment plan determined by diagnostic/treatment team including: a. Type of planned breast and axillary surgery; b. Type of planned radiotherapy to breast/node/chest wall; c. Type of planned systemic therapy (including chemotherapy, HER2 directed therapy, endocrine therapy, neoadjuvant therapy). 4) Be willing and able to comply with requirements of study. 5) Completed baseline PROMs after signing consent and willing to complete specified PROMs in English throughout out the study.
Exclusion criteria
Any one of the following is regarded as a criterion for exclusion from the study: 1) Distant metastatic disease beyond the breast and locoregional ipsilateral lymph nodes. 2) Locally advanced inoperable breast cancer including inflammatory breast cancer or supraclavicular node involvement. 3) Previous cancer on the same side. 4) Classical lobular carcinoma in situ (LCIS) (pleomorphic LCIS is acceptable). 5) Other non-malignant systemic diseases (cardiovascular, renal, hepatic, lung, etc.) that would prevent curative intent surgery to the breast primary and lymph nodes. 6) Undergone study specific MRI before registration. Study specific MRI can only occur after registration. 7) Unable to undergo MRI: a. MRI is not suitable for participants with any of the following: pacemaker, implanted non-MRI compatible devices, cochlear implants, neurostimulators, insulin infusion pumps, estimated Glomerular Filtration Rate (eGFR) < 30 mL/min/1.73m^2. b. Compatibility checks are required for: aneurysm clips, those with a history of metallic ocular foreign bodies, vascular coils, stents and filters, eye implants and heart valve replacements.
Outcome results
None listed