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

• Sponsor: The Leeds Teaching Hospitals NHS Trust (Other)
• Overall Status: Unknown status
• CT.gov ID: NCT04468867
• Collaborator: (none)
• Enrollment: 100
• Location: 1
• Arm: 1
• Anticipated Duration (Months): 34.3
• Patients Per Site Per Month: 2.9

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Diagnostic Test: Automated whole breast ultrasound; Diagnostic Test: Breast MRI	N/A

Study Design

• Study Type: Interventional
• Anticipated Enrollment: 100 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Diagnostic
• Official Title: Role of ABUS as an Alternative to Breast MRI in Assessing Response to Neoadjuvant Chemotherapy
• Actual Study Start Date: Aug 22, 2019
• Anticipated Primary Completion Date: Jun 30, 2022
• Anticipated Study Completion Date: Jun 30, 2022

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Patient group	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; Diagnostic Test: Breast MRI; This will be performed by band 6 or 7 radiographer with MRI training

Outcome Measures

Primary Outcome Measures

1. Tumour size [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).

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 100 Years
• Sexes Eligible for Study: Female
• Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Leeds Teaching Hospitals NHS Trust	Leeds	West Yorkshire	United Kingdom	LS9 7TF

Sponsors and Collaborators

• The Leeds Teaching Hospitals NHS Trust

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: The Leeds Teaching Hospitals NHS Trust
• ClinicalTrials.gov Identifier: NCT04468867
• Other Study ID Numbers: RD19/121361
• First Posted: Jul 13, 2020
• Last Update Posted: Jul 13, 2020
• Last Verified: Jul 1, 2020

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Study Results

No Results Posted as of Jul 13, 2020