Breast Tumour Size Measurement by Field Cycling Imaging (BREVIA)

March 19, 2026 updated by: University of Aberdeen

The goal of this study is to test if a new type of MRI scanner, called Field-Cycling Imaging (FCI), can accurately estimate tumour size in patients with a type of breast cancer called ductal carcinoma in situ (DCIS). The main question it aims to answer is:

Can FCI accurately estimate DCIS lesion size compared with histology results?

Participants will have a standard MRI scan and an FCI scan before undergoing surgery to remove the tumour.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

12

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

Study Locations

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

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Female patients from the Breast Unit of Aberdeen Royal Infirmary diagnosed with DCIS on clinical imaging with a breast tumour of at least 1 cm on imaging undergoing surgery.

Description

Inclusion Criteria:

  • Females ≥ 18 years old.
  • Subjects diagnosed with DCIS on initial biopsy.
  • Lesion size >1 cm on imaging.
  • Subjects undergoing surgery as part of their treatment.
  • Able to fit comfortably in the scanners.
  • Able to understand written and spoken English.

Exclusion Criteria:

  • Subjects undergoing chemotherapy or hormonal therapy.
  • Individuals unable to give informed consent.
  • Contra-indications to MRI scanning such as implantable cardiac devices.
  • Known allergy to contrast agent.

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

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Breast Cancer
Participants with breast cancer of ductal carcinoma in-situ (DCIS) who are due to undergo surgical treatment.
Other: 3T MRI research scan
Baseline MRI scan
Other: Field-Cycling Imaging research scan
Baseline FCI scan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Accuracy of DCIS lesion size estimation using FCI, validated against histopathological measurements (gold standard).
Time Frame: Baseline
Extent of agreement between lesion size estimation by FCI and actual lesion size according to NHS histopathology results.
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Comparison of DCIS lesion measurements using FCI and 3T MRI.
Time Frame: Baseline
Extent of agreement in lesion size measurements between FCI and conventional 3T MRI.
Baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Aberdeen

Collaborators

NHS Grampian

Investigators

  • Study Chair: Vasiliki Mallikourti, PhD, University of Aberdeen

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

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 (Estimated)

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Study Registration Dates

First Submitted

March 19, 2026

First Submitted That Met QC Criteria

March 19, 2026

First Posted (Actual)

March 25, 2026

Study Record Updates

Last Update Posted (Actual)

March 25, 2026

Last Update Submitted That Met QC Criteria

March 19, 2026

Last Verified

March 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2-082-25
  • 25/NW/0355 (Other Identifier: North West - Preston Research Ethics Committee)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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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