Contrast-Free Magnetic Resonance Imaging for Breast Disease (IMOGEN)

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.

Study Overview

• Status: Active, not recruiting
• Conditions: Breast Cancer; Breast Diseases
• Intervention / Treatment: Diagnostic test: Outpatient MRI

Detailed Description

It is widely recognised that mammography is highly sensitive for detecting breast lesions and a valuable tool for early detection of breast cancer, especially in post-menopausal women with non-dense breast tissue. On post-menopausal non-dense breast tissue, mammography is 90% effective at identifying breast tumours. However, for dense breast tissue, the sensitivity falls to 67%. This means that for women with dense breast tissue, which includes almost all pre-menopausal women and many post- menopausal women, mammography misses one third of tumours.

MRI is the imaging method of choice for detecting breast cancer in women with dense breast tissue however the standard MRI for breast cancer investigation typically uses gadolinium contrast agent. This method is called dynamic contrast enhanced (DCE) MRI and identifies localised regions of (neo)vascularity, which indicates a cancerous lesion. Although DCE can provide valuable information about the tissue, it is often not performed well, is poorly tolerated by patients, and adds additional time to the scan protocol.

Perspectum conducted a recent study demonstrating that liver cancer lesions can be identified using quantitative T1 maps calculated form multiparametric MRI data. Applying this MRI method to breast imaging, would potentially provide a method of identifying breast cancer lesions without using a contrast agent, reducing the scan time and eliminating the need for an intravenous contrast.

The aim of this study is to apply quantitative multiparametric MRI techniques to the area of breast imaging with the aim of developing a contrast-free MR scan which can diagnose the spectrum of breast disease referred to a secondary care breast clinic, including in women with dense breasts.

• Study Type: Observational
• Enrollment (Estimated): 1030

Contacts and Locations

Study Locations

• United Kingdom
  • Oxford, United Kingdom, OX4 2LL
    • Gemini One

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

• 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.

Exclusion Criteria

• 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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Qualitatively assess the participant experience of identifying breast disease using non-contrast MRI	Provide participants with a non validated questionnaire and summarise feedback on MR techniques compared to standard of care	36 months

Collaborators and Investigators

• Sponsor: Perspectum
• Investigators: Principal Investigator: Rajarshi Banerjee, MSc, DPhil, Honorary Consultant Physician, Oxford University NHS Foundation Trust

Publications and helpful links

General Publications

• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): July 6, 2021
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): April 30, 2027

Study Registration Dates

• First Submitted: July 14, 2021
• First Submitted That Met QC Criteria: August 6, 2021
• First Posted (Actual): August 16, 2021

Study Record Updates

• Last Update Posted (Actual): May 20, 2026
• Last Update Submitted That Met QC Criteria: May 19, 2026
• Last Verified: May 1, 2026

More Information

Terms related to this study

• Keywords: Magnetic resonance imaging; Screening; Breast imaging
• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Breast Diseases; Investigative Techniques; Diagnostic Techniques and Procedures; Diagnosis; Circulatory and Respiratory Physiological Phenomena; Physiological Phenomena; Genetic Phenomena; Physical Examination; Body Size; Body Weights and Measures; Body Constitution; Physical Appearance, Body; Anthropometry; Growth; Growth and Development; Vital Signs; Hemodynamics; Cardiovascular Physiological Phenomena; Body Height; Genotype; Blood Pressure
• Other Study ID Numbers: 20/WS/0110

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: At the end of the study, the pooled and anonymous results of the questionnaires will be available to all participants upon their request. No individual participant will be identified.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No