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Clinical Trial Details — Status: Recruiting

Administrative data

NCT number NCT04468867
Other study ID # RD19/121361
Secondary ID
Status Recruiting
Phase N/A
First received
Last updated
Start date August 22, 2019
Est. completion date June 30, 2022

Study information

Verified date July 2020
Source The Leeds Teaching Hospitals NHS Trust
Contact Nisha Sharma, mMBChB, MRCP (UK), FRCR
Phone 0113 2063798
Email nisha.sharma2@nhs.net
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Recruiting
Enrollment 100
Est. completion date June 30, 2022
Est. primary completion date June 30, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 100 Years
Eligibility 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

Study Design


Related Conditions & MeSH terms


Intervention

Diagnostic Test:
Automated whole breast ultrasound
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
Breast MRI
This will be performed by band 6 or 7 radiographer with MRI training

Locations

Country Name City State
United Kingdom Leeds Teaching Hospitals NHS Trust Leeds West Yorkshire

Sponsors (1)

Lead Sponsor Collaborator
The Leeds Teaching Hospitals NHS Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary Tumour size 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
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