Non-Contrast-Enhanced Breast MRI in the Evaluation of Newly Diagnosed Breast Cancer: A Pilot Study
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexFemale
Age18+
SponsorMassachusetts General Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
Disqualifiers
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 design
Design model
Single group
Treatments tested in this trial
Non-Contrast-Enhanced Breast MRI
DeviceA 5-minute NC-MRI sequence is the research intervention being evaluated
Treatment groups
20 Participants
are divided into 1 treatment groupGroup A: Non-Contrast-Enhanced Breast MRIExperimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
Feasibility of Non-Contrast-Enhanced MRI Acquisition
Time frame
12 monthsSecondary outcomes
1
Agreement Between NC-MRI and CE-MRI
Time frame
12 MonthsLocations
Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
This trial is not recruiting at the moment. You can still explore other options: