NCT07492043

Brief 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.

Trial Health

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Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
12

participants targeted

Target at below P25 for all trials

Timeline
4mo left

Started Apr 2026

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
not yet recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress53%
Apr 2026Dec 2026

First Submitted

Initial submission to the registry

March 19, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

March 25, 2026

Completed
7 days until next milestone

Study Start

First participant enrolled

April 1, 2026

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2026

Last Updated

March 25, 2026

Status Verified

March 1, 2026

Enrollment Period

8 months

First QC Date

March 19, 2026

Last Update Submit

March 19, 2026

Conditions

Keywords

Field-Cycling ImagingFCIDCISBreast Cancer

Outcome Measures

Primary Outcomes (1)

  • Accuracy of DCIS lesion size estimation using FCI, validated against histopathological measurements (gold standard).

    Extent of agreement between lesion size estimation by FCI and actual lesion size according to NHS histopathology results.

    Baseline

Secondary Outcomes (1)

  • Comparison of DCIS lesion measurements using FCI and 3T MRI.

    Baseline

Study Arms (1)

Breast Cancer

Participants with breast cancer of ductal carcinoma in-situ (DCIS) who are due to undergo surgical treatment.

Other: Field-Cycling Imaging research scanOther: 3T MRI research scan

Interventions

Baseline FCI scan

Breast Cancer

Baseline MRI scan

Breast Cancer

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University of Aberdeen

Aberdeen, United Kingdom

Location

Related Publications (1)

  • 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: 39478081BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, Noninfiltrating

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Study Officials

  • Vasiliki Mallikourti, PhD

    University of Aberdeen

    STUDY CHAIR

Central Study Contacts

Vasiliki Mallikourti, PhD

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 19, 2026

First Posted

March 25, 2026

Study Start

April 1, 2026

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2026

Last Updated

March 25, 2026

Record last verified: 2026-03

Locations