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Magnet Resonance to Manage Breast Disease

Magnetic Resonance Spectroscopy to Document Alterations to Biochemistry in Breast Disease

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
ANZCTR
Registry ID
ACTRN12617000679381
Enrollment
450
Registered
2017-05-12
Start date
2017-04-03
Completion date
2019-01-01
Last updated
2017-05-22

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

Conditions

None listed

Brief summary

Background Breast cancer is the most common cancer in women in Australia and the second most common cancer to cause death in women, after lung cancer. The symptoms of breast disease include new lumps, thickening in the tissues including under the arm, nipple sores, nipple discharge, dimpling of the skin and red or swollen breasts. The cause of breast cancer is unknown, but risk factors include; increasing age, family history, inheritance of mutation in the genes BRCA1 and BRCA2, exposure to female hormones and obesity. Study Aims: This study aims to identify biochemical markers associated with breast cancer using Magnetic Resonance Spectroscopy. You will undergo vivo MR spectroscopy to identify the pathology of any lesions identified by MR through looking at the biochemical deregulation of the tumour. This information will ascertain if in vivo MR spectroscopy combined with contrast-enhanced MRI can distinguish DCIS from invasive cancer. This will be achieved by comparison with post-operative pathology. Through collecting this information we aim to develop an approach to improve diagnostic timeframes and pre-operative planning of breast disease management by combining MRI, MRS and the current imaging approaches. Moreover, we aim to produce technology that can identify the spread of malignant disease to the surrounding nodes. Study details If you are scheduled for surgery: A biopsy or a small piece of tissue will be collected by your surgeon prior to surgery for the purpose of this study. This tissue will be examined under Magnetic Resonance Spectroscopy. If you are a volunteer who is identified as a carrier of BRCA1 and/or BRCA2 mutations:([Blood samples will be used to confirm BRCA1 and/or BRCA2 mutations) If you are a healthy volunteer or do not carry the gene(s) or have not been diagnosed with breast cancer BRCA1 and BRCA2 genetic status will first be determined with a blood test to confirm absence of BRCA mutations. All study participants will be provided an appointment at the imaging facility closest to them to complete an MRI and MRS of breasts. During your visit to the imaging facility you will be required to undergo two non-invasive imaging procedures with a clinical scanner used for routine testing. Your two scan procedures will be done in a single visit on the same day with a short break in between. For the 1st MRS scan you will require to lie in the scanner for approximately 40 minutes. During this scan images of your breast and information on its chemistry will be obtained. The 2nd MRI scan is a functional MRI and will assess the blood flow in different areas of your breast. This scan will take approximately 45 minutes. These are additional MR scans which you would not be undergoing unless you were part of the study.

Interventions

You will need to return a signed consent form prior to participation. Upon return of the consent form you will be asked to participate in the following; If you are scheduled for surgery; A biopsy or a small piece of tissue will be collected by your surgeon prior to surgery for the purpose of this study. This tissue will be examined under Magnetic Resonance Spectroscopy within hours of sample collection. After your biopsy, you will also be provided an appointment time at the imaging facility c

You will need to return a signed consent form prior to participation. Upon return of the consent form you will be asked to participate in the following; If you are scheduled for surgery; A biopsy or a small piece of tissue will be collected by your surgeon prior to surgery for the purpose of this study. This tissue will be examined under Magnetic Resonance Spectroscopy within hours of sample collection. After your biopsy, you will also be provided an appointment time at the imaging facility closest to you to complete a MRI and MRS of your breasts. If you are a volunteer who is identified as carriers of BRCA1 and/or BRCA2 mutations; If you have an unconfirmed BRCA genetic status, but identify as potentially possessing the gene mutation, due to your family history, you will be asked to provide blood for analysis. Blood collection will be completed with either the relevant hospital’s blood collection services or at the Clinical Research Facility. The amount of blood collected for BRCA genetic testing is 16mls. For those participants who have a confirmed BRCA1 or 2 mutation you will then be provided an appointment time at the imaging facility closest to you to complete a MRI and MRS of your breasts. Along with your regular clinician, the study will provide yearly follow up MRI/MRS imaging for further monitoring for the entirety of the study. The number of follow up appointments will be determined by factors such as what time point you enrolled into the study and how close your enrolment is to the closure of the study. NB: If abnormalities in the tissue are detected, your referring doctor will be notified and you may require a biopsy. If you are a healthy volunteer or do not carry the gene(s) or have not been diagnosed with breast cancer; If you have an unconfirmed BRCA genetic status, you will be asked to provide blood for analysis. Blood collection will be completed with either the relevant hospital’s blood collection services or at the Clinical Research Facility. The amount of blood collected for BRCA genetic testing is 16ml. Once confirmed that you do not carry the BRCA1 or BRCA2 gene, you will then be provided an appointment time at the imaging facility closest to you to complete a MRI and MRS of your breasts. If you are confirmed to be eligible to proceed on to have the imaging of your breast then the research nurse will arrange an appointment visit for you at one of the following facilities: -Herston Imaging Research Facility, Royal Brisbane and Women’s Hospital campus, Bowen Bridge Road, Herston -Princess Alexandra Hospital Medical Imaging Department, Ipswich Road, Wolloongabba -Hunter Medical Research Institute Imaging Centre, John Hunter Hospital campus Newcastle, Lookout Road, Newcastle During your visit to the imaging facility you will be required to undergo two non-invasive imaging procedures with a clinical scanner used for routine testing. Your two scan procedures will be done in a single visit on the same day with a short break in between. For the 1st MRS scan you will require to lie in the scanner for approximately 40 minutes. During this scan images of your breast and information on its chemistry will be obtained. The 2nd MRI scan is a functional MRI and will assess the blood flow in different areas of your breast. This scan will take approximately 45 minutes. These are additional MR scans which you would not be undergoing unless you were part of the study. As it is unknown how pregnancy may affect chemical changes, pregnant females cannot participate in this study. So if you are a female participant of child bearing potential and you suspect you may have become pregnant prior to attending for your imaging appointment you will be asked to contact the research nurse who will arrange for you to have a urine pregnancy test. The major discomforts of an MRI are that the scanner is noisy. You will be offered earphones to reduce the noise. Some people may experience symptoms of claustrophobia from lying in a confined space. Should you feel discomfort or become distressed while lying in the MR scanner the healthcare specialist working with you at that time will provide information and advice regarding additional support and/or referral for your particular concerns. You can signal at any time that you wish to be stop the scan and the healthcare specialist will stop the scan and assist you.

Sponsors

Translational Research Institute
Lead SponsorOther

Eligibility

Sex/Gender
All
Age
18 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

Confirmed Breast Lesions or Possession of BRCA 1 or 2 mutation and no current or past history of breast cancer or No history of breast cancer or possession of BRCA1/2 mutation if participating as a healthy control

Exclusion criteria

Pregnancy Metal objects in the body Breast Implants Unable to provide informed consent

Outcome results

None listed

Source: ANZCTR · Data processed: Feb 4, 2026