Breast CancerNCT07874256
Non-Contrast-Enhanced Breast MRI in the Evaluation of Newly Diagnosed Breast Cancer: A Pilot Study
A study testing Non-Contrast-Enhanced Breast MRI in people with Breast Cancer and Breast Cancer Detection, run by Massachusetts General Hospital.
Trial summary
This pilot study is evaluating whether breast MRI without contrast dye can provide useful information in patients who have recently been diagnosed with breast cancer. The study uses MRI techniques to look at breast tissue and the extent of cancer without an intravenous gadolinium injection and compare it to contrast… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer, Breast Cancer Detection
- What is being tested?
- Non-Contrast-Enhanced Breast MRI
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- No sites listed yet
- Study dates
- Nov 2026to Nov 2027
- Phase
- Interventional
- 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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged 18 years or older.
- Pathologically confirmed, newly diagnosed breast cancer.
- Scheduled to undergo a clinically indicated contrast-enhanced breast MRI (CE-MRI) at Massachusetts General Hospital.
- Able to provide verbal informed consent as approved by the IRB.
Who cannot join
- Pregnancy.
- Any contraindication to MRI, including unsafe or non-MRI-compatible implanted medical devices or metallic foreign bodies.
- Inability to safely undergo breast MRI or remain still for the duration of the examination.
- Inability to complete the additional approximately 5-minute NC-MRI sequence.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
This pilot study is evaluating whether breast MRI without contrast dye can provide useful information in patients who have recently been diagnosed with breast cancer. The study uses MRI techniques to look at breast tissue and the extent of cancer without an intravenous gadolinium injection and compare it to contrast enhanced MRI.
- Conditions
- Breast Cancer, Breast Cancer Detection
- Being tested
- Non-Contrast-Enhanced Breast MRI
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Non-Contrast-Enhanced Breast MRIDevice
A 5-minute NC-MRI sequence is the research intervention being evaluated
| Study group | Role | What they receive |
|---|---|---|
| Non-Contrast-Enhanced Breast MRI | Experimental | Not described Receives: Device: Non-Contrast-Enhanced Breast MRI |
What is being measured
The primary outcome is the main question the study is designed to answer.
Feasibility of Non-Contrast-Enhanced MRI Acquisition
Measured: 12 months
Secondary outcomes (1)
Agreement Between NC-MRI and CE-MRI
Measured: 12 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2026
- Study startNov 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionNov 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
- 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- Single-arm, prospective, within-subject pilot study:
- Masking
- None (open label)
- Enrolment
- 20 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Massachusetts General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hajer Jarraya, Massachusetts General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07874256
- Sponsor's protocol ID
- 26-331
- Status last verified
- Oct 2026
- First submitted
- 6 Oct 2026
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- Yes
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Non-Contrast-Enhanced Breast MRI in the Evaluation of Newly Diagnosed Breast Cancer: A Pilot Study
- ClinicalTrials.gov ID
- NCT07874256
- Acronym / sponsor ID
- 26-331
- Conditions
- Breast Cancer, Breast Cancer Detection
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 20 participants (estimated)
- Lead sponsor
- Massachusetts General HospitalUniversity, hospital or other
- Study start
- Nov 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Nov 2027 (estimated)
- First posted
- 14 Oct 2026 (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.
This pilot study is evaluating whether breast MRI without contrast dye can provide useful information in patients who have recently been diagnosed with breast cancer. The study uses MRI techniques to look at breast tissue and the extent of cancer without an intravenous gadolinium injection and compare it to contrast enhanced MRI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- Single-arm, prospective, within-subject pilot study:
| Arm | Type | Receives |
|---|---|---|
| Non-Contrast-Enhanced Breast MRI | Experimental | Device: Non-Contrast-Enhanced Breast MRI |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Women aged 18 years or older.
- Pathologically confirmed, newly diagnosed breast cancer.
- Scheduled to undergo a clinically indicated contrast-enhanced breast MRI (CE-MRI) at Massachusetts General Hospital.
- Able to provide verbal informed consent as approved by the IRB.
Key exclusion criteria (4 listed)
- Pregnancy.
- Any contraindication to MRI, including unsafe or non-MRI-compatible implanted medical devices or metallic foreign bodies.
- Inability to safely undergo breast MRI or remain still for the duration of the examination.
- Inability to complete the additional approximately 5-minute NC-MRI sequence.
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 |
|---|---|---|
| Non-Contrast-Enhanced Breast MRIA 5-minute NC-MRI sequence is the research intervention being evaluated | Device | Non-Contrast-Enhanced Breast MRI |
Primary outcome
Feasibility of Non-Contrast-Enhanced MRI Acquisition
Time frame: 12 months
1 secondary outcome
Agreement Between NC-MRI and CE-MRI
Time frame: 12 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 14 Oct 2026.
- Individual participant dataSharing planned: No
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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.
Questions about this trial
What is this clinical trial studying?
A study testing Non-Contrast-Enhanced Breast MRI in people with Breast Cancer and Breast Cancer Detection, run by Massachusetts General Hospital.
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 4 inclusion and 4 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: opening soon, as of the sponsor's last update on 14 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
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?
Contact HAJER JARRAYA, MD (617-724-9729, hjarraya@mgh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Feasibility of Non-Contrast-Enhanced MRI Acquisition (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 14 Oct 2026.