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

NCT ID: NCT04468867

Last Updated: 2020-07-13

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 100 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-08-22
• Study Completion Date: 2022-06-30

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: DIAGNOSTIC
• Blinding Strategy: NONE

Study Groups

Patient group

Group Type: EXPERIMENTAL

Automated whole breast ultrasound

Intervention Type: DIAGNOSTIC_TEST

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

Intervention Type: DIAGNOSTIC_TEST

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

Interventions

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

Intervention Type: DIAGNOSTIC_TEST

Breast MRI

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

Intervention Type: DIAGNOSTIC_TEST

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 100 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

The Leeds Teaching Hospitals NHS Trust

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Locations

Leeds Teaching Hospitals NHS Trust

Leeds, West Yorkshire, United Kingdom

Site Status: RECRUITING

Countries

United Kingdom

Central Contacts

Nisha Sharma, mMBChB, MRCP (UK), FRCR

Role: CONTACT

nisha.sharma2@nhs.net

0113 2063798

Facility Contacts

Nisha Sharma, mMBChB, MRCP (UK), FRCR

Role: primary

Other Identifiers

RD19/121361

Identifier Type: -

Identifier Source: org_study_id