- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04468867
Role of ABUS as an Alternative to Breast MRI in Assessing Response to Neoadjuvant Chemotherapy (RABUS)
July 8, 2020 updated by: The Leeds Teaching Hospitals NHS Trust
Some women who have been diagnosed with a breast cancer will require chemotherapy as part of their treatment.
The chemotherapy can be given before breast surgery - neoadjuvant chemotherapy or after breast surgery - adjuvant chemotherapy.
Whether chemotherapy is given before or after does not affect the clinical outcomes for the woman - ie there is no disadvantage to the woman.
Due to the fact that giving chemotherapy before has no disadvantages, many of the oncologists like to give the chemotherapy before because they can see if the breast cancer is responding.
They are able to do this by using imaging.
The best imaging test is breast MRI.
Ultrasound can be used but studies have shown that it is not as good.
However, whole breast ultrasound (ABUS) provides 3 dimensional information similar to breast MRI and the purpose of our study is to see if ABUS performs similar to breast MRI in being able to see if a tumour is responding to the chemotherapy.
The breast MRI requires women to lie facing down and takes about 20mins.
It involves an injection of contrast called gadolinium via a cannula.
ABUS involves scanning the whole breast with the patient lying on their back and takes 10mins.
There is no injection of contrast.
MRI is an expensive test and often there is limited access to the scanner and so patients may have to wait for an appointment.
ABUS because it is an automated process for obtaining the images can be performed in the breast unit in a timely manner without the issue of competing demands.
All women who agree to take part in the study will have both the breast MRI - standard or care and the ABUS.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
100
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Nisha Sharma, mMBChB, MRCP (UK), FRCR
- Phone Number: 0113 2063798
- Email: nisha.sharma2@nhs.net
Study Locations
-
-
West Yorkshire
-
Leeds, West Yorkshire, United Kingdom, LS9 7TF
- Recruiting
- Leeds Teaching Hospitals NHS Trust
-
Contact:
- Nisha Sharma, mMBChB, MRCP (UK), FRCR
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 100 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- All female participants eligible for neoadjuvant chemotherapy and planning surgical treatment
- Able to give informed consent
Exclusion Criteria:
- All female particpants having neoadjuvant chemotherapy as palliative treatment with no surgery planned
- Unable to provide informed consent
- Unable to have breast MRI scan due to clautrophobia or allergy to gadolineum
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Diagnostic
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Patient group
|
This will be performed by a band 6 radiographer and will be done at baseline, post 2 cycles of chemotherapy and end of treatment chemotherapy
This will be performed by band 6 or 7 radiographer with MRI training
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Tumour size
Time Frame: 20 mins
|
Response will be assessed using RECIST criteria.
Longest diameter response was scored based on the RECIST guidelines (PD>20% increase, SD<20% increase to<30% decrease, PR>30% decrease in longest diameter and CR if no tumour is visible).
|
20 mins
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
August 22, 2019
Primary Completion (Anticipated)
June 30, 2022
Study Completion (Anticipated)
June 30, 2022
Study Registration Dates
First Submitted
July 8, 2020
First Submitted That Met QC Criteria
July 8, 2020
First Posted (Actual)
July 13, 2020
Study Record Updates
Last Update Posted (Actual)
July 13, 2020
Last Update Submitted That Met QC Criteria
July 8, 2020
Last Verified
July 1, 2020
More Information
Terms related to this study
Other Study ID Numbers
- RD19/121361
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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