Breast CancerIMOGENNCT05006196
Contrast-Free Magnetic Resonance Imaging for Breast Disease
An observational study of Breast Cancer and Breast Diseases, run by Perspectum at 1 site in United Kingdom.
Trial 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. Read more about this study
- Who is it for?
- Ages 30 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Breast Cancer, Breast Diseases
- What is being tested?
- Outpatient MRI
- How many people
- 1,030 participants
- Where
- 1 siteUnited Kingdom
- Study dates
- 6 Jul 2021to 30 Apr 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 30 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Women at risk of breast cancer or who have suspected breast disease aged 30 years and older.
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read the 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.
- Conditions
- Breast Cancer, Breast Diseases
- Being tested
- Outpatient MRI
- Keywords
- Breast imaging, Magnetic resonance imaging, Screening
- Medical subject headings
- Breast Neoplasms, Breast Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Outpatient MRIDiagnostic test
Also called Outpatient blood tests for laboratory studies and genotyping, Outpatient measurements (height, weight, blood pressure), Patient questionnaires
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.
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 36 months
Secondary outcomes (1)
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
Measured: 36 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Aug 2021
- Study start6 Jul 2021
- Primary completion31 Dec 2026 (estimated)
- Study completion30 Apr 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 1,030 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Perspectum
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Rajarshi Banerjee, MSc, DPhil, Principal investigator, Honorary Consultant Physician, Oxford University NHS Foundation Trust
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05006196
- Sponsor's protocol ID
- 20/WS/0110
- Acronym
- IMOGEN
- Status last verified
- May 2026
- First submitted
- 14 Jul 2021
- Last updated
- 20 May 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: 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.
Publications
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.
PubMed 31623646Bakker 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.
PubMed 31774954Buderer 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.
PubMed 8870764
Study at a glance
From the registry record, last updated by the sponsor on 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-Free Magnetic Resonance Imaging for Breast Disease
- ClinicalTrials.gov ID
- NCT05006196
- Acronym / sponsor ID
- IMOGEN / 20/WS/0110
- Conditions
- Breast Cancer, Breast Diseases
- Keywords
- Breast imaging, Magnetic resonance imaging, Screening
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 1,030 participants (estimated)
- Lead sponsor
- PerspectumIndustry (pharma, biotech, devices)
- Study start
- 6 Jul 2021 (actual)
- Primary completion
- 31 Dec 2026 (estimated)
- Study completion
- 30 Apr 2027 (estimated)
- First posted
- 16 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
Who may qualify
- Ages
- 30 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Women at risk of breast cancer or who have suspected breast disease aged 30 years and older.
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Outpatient MRIAlso: Outpatient blood tests for laboratory studies and genotyping, Outpatient measurements (height, weight, blood pressure), Patient questionnairesParticipation 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. | Diagnostic test | – |
Primary outcome
Determine the diagnostic performance of a non-contrast MRI in breast disease
Time frame: 36 months
Mapping multi-parametric algorithms and assessing diagnostic performance compared to standard of care using area under the receiver operative curve (AUROC)
1 secondary outcome
Qualitatively assess the participant experience of identifying breast disease using non-contrast MRI
Time frame: 36 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Background: PubMed 31623646von 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.
- Background: PubMed 31774954Bakker 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.
- Background: PubMed 8870764Buderer 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.
- Individual participant dataSharing planned: No. 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Rajarshi Banerjee, MSc, DPhil principal investigator
Honorary Consultant Physician, Oxford University NHS Foundation Trust
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer and Breast Diseases, run by Perspectum at 1 site in United Kingdom.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 20 May 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Kingdom. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Determine the diagnostic performance of a non-contrast MRI in breast disease (time frame: 36 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05006196, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 May 2026.