Non-contrast MRI for assessing breast disease
Contrast-Free Magnetic Resonance Imaging for Breast Disease
This study is testing a new type of MRI that doesn't use contrast dye to see if it can better help women at risk for breast cancer or with suspected breast issues.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 1030 (estimated) |
| Ages | 30 Years and up |
| Sex | Female |
| Sponsor | Perspectum Industry-sponsored |
| Locations | 1 site (Oxford) |
| Trial ID | NCT05006196 on ClinicalTrials.gov |
What this trial studies
This observational cohort study aims to evaluate the diagnostic performance of a quantitative, non-contrast MRI method for women at risk of breast cancer or with clinically suspected breast disease. Traditional mammography is less effective for women with dense breast tissue, leading to missed diagnoses. The study seeks to apply a novel MRI technique that eliminates the need for gadolinium contrast agents, potentially improving patient comfort and reducing scan times. Participants will undergo outpatient MRI scans to assess the effectiveness of this new imaging approach.
Who should consider this trial
Good fit: Ideal candidates are females aged 30 and over who have been referred to a secondary care breast screening clinic.
Not a fit: Patients with known contraindications to MRI or significant underlying health issues may not benefit from this study.
Why it matters
Potential benefit: If successful, this method could provide a safer and more effective imaging option for detecting breast cancer in women with dense breast tissue.
How similar studies have performed: While traditional MRI methods require contrast agents, this approach is novel and has not been widely tested in breast imaging.
Eligibility criteria
Show full inclusion / exclusion criteria
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.
Where this trial is running
Oxford
- Gemini One — Oxford, United Kingdom (Recruiting)
Study contacts
- Principal investigator: Rajarshi Banerjee, MSc, DPhil — Honorary Consultant Physician, Oxford University NHS Foundation Trust
- Study coordinator: Gemma Greenall, BSc
- Email: IMOGEN@perspectum.com
- Phone: 01865655343
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.