Breast Tumour Size Measurement by Field Cycling Imaging

NCT07492043 — Not yet recruiting, 12 participants, University of Aberdeen

ClinicalTrials Daily · Areas · Conditions · Drugs · Sponsors ·

Registry	NCT07492043, acronym BREVIA
Status	Not yet recruiting
Study type	Observational
Enrollment	12 (Estimated)
Sponsor	University of Aberdeen (Other); collaborators: NHS Grampian
Conditions	Breast Cancer, Ductal Carcinoma In Situ
Interventions	Field-Cycling Imaging research scan, 3T MRI research scan (Other)
Dates	start 2026-04-01 (estimated), primary completion 2026-12-01 (estimated), completion 2026-12-01 (estimated), first posted 2026-03-25, last updated 2026-03-25
Locations	1 site in United Kingdom

-Summary

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.

Expand all sections · Collapse all

+Arms and interventions

Arm	Type	Interventions	Description
Breast Cancer		Other: Field-Cycling Imaging research scan; Other: 3T MRI research scan	Participants with breast cancer of ductal carcinoma in-situ (DCIS) who are due to undergo surgical treatment.

Field-Cycling Imaging research scan (Other): Baseline FCI scan
3T MRI research scan (Other): Baseline MRI scan

+Outcome measures

Primary outcomes

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

Secondary outcomes

Comparison of DCIS lesion measurements using FCI and 3T MRI. [Baseline]: Extent of agreement in lesion size measurements between FCI and conventional 3T MRI.

+Eligibility

Sex: Female, ages: 18 Years to any

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.

+Locations (1)

Facility	City	Country	Status
University of Aberdeen	Aberdeen	United Kingdom

+Publications

Mallikourti V, Ross PJ, Maier O, Hanna K, Husain E, Davies GR, Lurie DJ, Lip G, Lahrech H, Masannat Y, Broche LM. Field cycling imaging to characterise breast cancer at low and ultra-low magnetic fields below 0.2 T. Commun Med (Lond). 2024 Oct 30;4(1):221. doi: 10.1038/s43856-024-00644-2. PMID 39478081

+Investigators

Vasiliki Mallikourti, PhD, Study chair, University of Aberdeen