Contrast-Free Magnetic Resonance Imaging for Breast Disease

NCT05006196 | Active Not Recruiting

• 1 other identifier: 20/WS/0110
• Study Type: observational
• Target: 1,030
• Locations: 1 country
• Sites: 1

Brief Summary

Prospective, observational cohort study looking at patients either at risk of breast cancer or have clinically suspected breast to assess the diagnostic performance of quantitative, non-contrast MRI.

Conditions

Breast Cancer; Breast Diseases

Keywords

Breast imaging; Magnetic resonance imaging; Screening

Outcome Measures

Primary Outcomes (1)

• Determine the diagnostic performance of a non-contrast MRI in breast disease

  Mapping multi-parametric algorithms and assessing diagnostic performance compared to standard of care using area under the receiver operative curve (AUROC)

  36 months

Secondary Outcomes (1)

• Qualitatively assess the participant experience of identifying breast disease using non-contrast MRI

  36 months

Interventions

Outpatient MRI DIAGNOSTIC_TEST

Participation in the study includes up to a maximum of 2 study visits. The visits will include clinical measurements (height, weight, blood pressure), blood tests, MRI scan and patient symptoms and experience questionnaires. There will be no medical interventions as part of the study. All participants will receive standard-of-care by their healthcare provider/s. With the participant's consent, the participant's primary care physician will be made aware of their participation in the study. Furthermore, participants will be informed of any structural abnormalities found in the MRI scan (e.g. abnormal vessels, haemangioma, tumour, cyst, among others) and abnormal blood test results as these may have clinical implications. These will be managed by the routine clinical care team as part of standard care.

Also known as: Outpatient blood tests for laboratory studies and genotyping, Outpatient measurements (height, weight, blood pressure), Patient questionnaires

Eligibility Criteria

• Age: 30 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Women at risk of breast cancer or who have suspected breast disease aged 30 years and older.

You may qualify if:

• Female 30 years of age and over
• Participant has been referred to a secondary care breast screening clinic.
• Participant is willing and able to give informed consent for participation in the investigation.

You may not qualify if:

• The participant may not enter the study with any known contraindication to magnetic resonance imaging (including but not limited to a pacemaker or other metallic unfixed implanted device, metallic fragments, extensive tattoos, severe claustrophobia).
• Any other cause, including a significant underlying disease or disorder which, in the opinion of the investigator, may put the participant at risk by participating in the study or limit the participant's ability to participate.

Sponsors & Collaborators

• Perspectum: lead

Study Sites (1)

Gemini One

Oxford, OX4 2LL, United Kingdom

Location

Related Publications (3)

• von Euler-Chelpin M, Lillholm M, Vejborg I, Nielsen M, Lynge E. Sensitivity of screening mammography by density and texture: a cohort study from a population-based screening program in Denmark. Breast Cancer Res. 2019 Oct 17;21(1):111. doi: 10.1186/s13058-019-1203-3.

  PMID: 31623646 BACKGROUND

• Bakker MF, de Lange SV, Pijnappel RM, Mann RM, Peeters PHM, Monninkhof EM, Emaus MJ, Loo CE, Bisschops RHC, Lobbes MBI, de Jong MDF, Duvivier KM, Veltman J, Karssemeijer N, de Koning HJ, van Diest PJ, Mali WPTM, van den Bosch MAAJ, Veldhuis WB, van Gils CH; DENSE Trial Study Group. Supplemental MRI Screening for Women with Extremely Dense Breast Tissue. N Engl J Med. 2019 Nov 28;381(22):2091-2102. doi: 10.1056/NEJMoa1903986.

  PMID: 31774954 BACKGROUND

• Buderer NM. Statistical methodology: I. Incorporating the prevalence of disease into the sample size calculation for sensitivity and specificity. Acad Emerg Med. 1996 Sep;3(9):895-900. doi: 10.1111/j.1553-2712.1996.tb03538.x.

  PMID: 8870764 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

The tests consist of complete blood count (CBC), biochemical profile and stored serum/plasma. Genetic testing for genetic variants associated with this disease may also be carried out if the participant gives informed consent for genetic testing.

MeSH Terms

Conditions

Breast Neoplasms; Breast Diseases

Interventions

Genotype; Body Height; Blood Pressure

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Genetic Phenomena; Body Size; Body Weights and Measures; Body Constitution; Physical Examination; Diagnostic Techniques and Procedures; Diagnosis; Physical Appearance, Body; Anthropometry; Investigative Techniques; Physiological Phenomena; Growth; Growth and Development; Vital Signs; Hemodynamics; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Officials

• Rajarshi Banerjee, MSc, DPhil

  Honorary Consultant Physician, Oxford University NHS Foundation Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: July 14, 2021
• First Posted: August 16, 2021
• Study Start: July 6, 2021
• Primary Completion: December 30, 2025
• Study Completion: December 30, 2025
• Last Updated: December 1, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)