Trial Review

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The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been endorsed by the ANZCTR. Before participating in a study, talk to your health care provider and refer to this information for consumers
Trial registered on ANZCTR


Registration number
ACTRN12617000679381
Ethics application status
Approved
Date submitted
8/05/2017
Date registered
12/05/2017
Date last updated
12/05/2017
Type of registration
Retrospectively registered

Titles & IDs
Public title
Magnet Resonance to Manage Breast Disease
Scientific title
Magnetic Resonance Spectroscopy to Document Alterations to Biochemistry in Breast Disease
Secondary ID [1] 291897 0
None
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Cancer 303175 0
Condition category
Condition code
Cancer 302618 302618 0 0
Breast

Intervention/exposure
Study type
Observational
Patient registry
False
Target follow-up duration
Target follow-up type
Description of intervention(s) / exposure
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.

Intervention code [1] 297999 0
Diagnosis / Prognosis
Comparator / control treatment
There is only a healthy control group for comparison of MRI and MRS images.
Control group
Active

Outcomes
Primary outcome [1] 302030 0
The primary outcome is to examine a biopsy taken from the primary lesion using MRS in the pathology magnet. This is done with the intention to ascertain the accuracy of this method in identifying if the tumour has spread to the nodes. This will be compared with standard practice sentinel node results. This will require an additional biopsy to be collected by the surgeon. Additional biopsies are required as a part of standard care for treatment of breast disease.
Timepoint [1] 302030 0
Your Surgeon will determine the time points of your standard care. The Magnetic Resonance Imaging will be completed within 24 hours of sample collection.
Secondary outcome [1] 334673 0
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.
Timepoint [1] 334673 0
You will be booked in for an MRI/MRS at a time convenient for you. Most scans aim to be completed within 4 weeks of recruitment into the study. Comparison of data will be completed in the data analysis phase of the research study. Analysis of data will commence in approx. year 2 of the study.

Eligibility
Key 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
Minimum age
18 Years
Maximum age
85 Years
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
Pregnancy
Metal objects in the body
Breast Implants
Unable to provide informed consent

Study design
Purpose
Screening
Duration
Longitudinal
Selection
Defined population
Timing
Prospective
Statistical methods / analysis
Magnetic Resonance images will be used to compare the biochemical peaks.

Recruitment
Recruitment status
Recruiting
Date of first participant enrolment
Anticipated
Actual
3/04/2017
Date of last participant enrolment
Anticipated
1/01/2019
Actual
Date of last data collection
Anticipated
1/01/2019
Actual
Sample size
Target
450
Accrual to date
Final
Recruitment in Australia
Recruitment state(s)
NSW,QLD
Recruitment hospital [1] 7952 0
Princess Alexandra Hospital - Woolloongabba
Recruitment hospital [2] 7953 0
Royal Brisbane & Womens Hospital - Herston
Recruitment hospital [3] 7954 0
John Hunter Hospital - New Lambton
Recruitment postcode(s) [1] 15926 0
2305 - New Lambton
Recruitment postcode(s) [2] 15925 0
4029 - Herston
Recruitment postcode(s) [3] 15924 0
4102 - Woolloongabba

Funding & Sponsors
Funding source category [1] 296381 0
Other
Name [1] 296381 0
Translational Research Institute
Country [1] 296381 0
Australia
Primary sponsor type
Other
Name
Translational Research Institute
Address
36 Kent Street
Woolloongabba QLD 4102
Country
Australia
Secondary sponsor category [1] 295329 0
None
Name [1] 295329 0
Address [1] 295329 0
Country [1] 295329 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 297619 0
Metro South Human Research Ethics Committee
Ethics committee address [1] 297619 0
36 Kent Street
Woolloongabba QLD 4102
Ethics committee country [1] 297619 0
Australia
Date submitted for ethics approval [1] 297619 0
11/05/2015
Approval date [1] 297619 0
19/05/2015
Ethics approval number [1] 297619 0
HREC/15/QPAH/298

Summary
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.
Trial website
https://www.tri.edu.au/research-program/breast-cancer
Trial related presentations / publications
Public notes
Attachments [1] 1706 1706 0 0
/AnzctrAttachments/372888-Clean PICF_High Risk BRACA 2.0_October 2016 - BRCA ONLY.pdf (Participant information/consent)
Attachments [2] 1707 1707 0 0
/AnzctrAttachments/372888-Approval.Metro.S.pdf (Ethics approval)
Attachments [3] 1708 1708 0 0
/AnzctrAttachments/372888-Protocol_MRS of Breast Disease_ v1.0_ October_2016.pdf (Protocol)

Contacts
Principal investigator
Name 74610 0
Prof Carolyn Mountford
Address 74610 0
Translational Research Institute
36 Kent Street
Woolloongabba Qld 4102
Country 74610 0
Australia
Phone 74610 0
+61734437000
Fax 74610 0
Email 74610 0
carolyn.mountford@tri.edu.au
Contact person for public queries
Name 74611 0
Mrs Lisa Rich
Address 74611 0
R-Wing
Princess Alexandra Hospital
199 Ipswich Rd
Woolloongabba QLD 4120
Country 74611 0
Australia
Phone 74611 0
+61731769002
Fax 74611 0
Email 74611 0
lisa.rich@tri.edu.au
Contact person for scientific queries
Name 74612 0
Prof Graham Galloway
Address 74612 0
Translational Research Institute
36 Kent Street
Woolloongabba QLD 4102
Country 74612 0
Australia
Phone 74612 0
+61734437000
Fax 74612 0
Email 74612 0
Graham.Galloway@tri.edu.au

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

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