Breast Tumour Size Measurement by Field Cycling Imaging

ConditionsBreast Cancer Ductal Carcinoma In Situ

Trial statusNot yet recruiting

Trial phaseNot listed

Trial typeObservational

Biological sexFemale

Age18+

SponsorUniversity of Aberdeen

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Cross-sectional

Treatments tested in this trial

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

Treatment groups

12 Participants

are divided into 1 treatment group

Group A: Breast Cancer2 interventions

Trial outcomes

Primary outcomes

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.

Time frame

Baseline

Secondary outcomes

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

Extent of agreement in lesion size measurements between FCI and conventional 3T MRI.

Time frame

Baseline

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

University of Aberdeen

Lead sponsor

NHS Grampian

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: