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Not yet recruiting NCT07492043

Breast Tumour Size Measurement by Field Cycling Imaging

Observational Breast Cancer Ductal Carcinoma In Situ

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Field-Cycling Imaging research scan, 3T MRI research scan.
Who it may be relevant to
Registry conditions: Breast Cancer, Ductal Carcinoma In Situ. Basic parameters: from 18 years · Female.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
United Kingdom
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Overview

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.

Interventions

  • Other Field-Cycling Imaging research scan
    Baseline FCI scan
  • Other 3T MRI research scan
    Baseline MRI scan

Primary outcome measures

  • Accuracy of DCIS lesion size estimation using FCI, validated against histopathological measurements (gold standard). [Time frame: Baseline]
Secondary outcome measures (1)
  • Comparison of DCIS lesion measurements using FCI and 3T MRI. [Time frame: Baseline]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Observational model
Cohort

Study locations

United Kingdom · 1 center
  • University of Aberdeen — Aberdeen

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

Identifiers

NCT: NCT07492043 · 2-082-25 · 25/NW/0355

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗