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Role of ABUS as an Alternative to Breast MRI in Assessing Response to Neoadjuvant Chemotherapy

Role of ABUS as an Alternative to Breast MRI in Assessing Response to Neoadjuvant Chemotherapy

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT04468867
Acronym
RABUS
Enrollment
100
Registered
2020-07-13
Start date
2019-08-22
Completion date
2022-06-30
Last updated
2020-07-13

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

Conditions

Breast Cancer

Brief summary

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.

Interventions

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

DIAGNOSTIC_TESTBreast MRI

This will be performed by band 6 or 7 radiographer with MRI training

Sponsors

The Leeds Teaching Hospitals NHS Trust
Lead SponsorOTHER

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
DIAGNOSTIC
Masking
NONE

Eligibility

Sex/Gender
FEMALE
Age
18 Years to 100 Years
Healthy volunteers
No

Inclusion criteria

1. All female participants eligible for neoadjuvant chemotherapy and planning surgical treatment 2. Able to give informed consent

Exclusion criteria

1. All female particpants having neoadjuvant chemotherapy as palliative treatment with no surgery planned 2. Unable to provide informed consent 3. Unable to have breast MRI scan due to clautrophobia or allergy to gadolineum

Design outcomes

Primary

MeasureTime frameDescription
Tumour size20 minsResponse 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).

Countries

United Kingdom

Contacts

Primary ContactNisha Sharma, mMBChB, MRCP (UK), FRCR
nisha.sharma2@nhs.net0113 2063798

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026