Multiparametric MRI for Assessing Breast Cancer Response to Anti-HER2 Therapy (NCT03738553) | Clinical Trial Compass
TerminatedNot Applicable
Multiparametric MRI for Assessing Breast Cancer Response to Anti-HER2 Therapy
Stopped: Study closed to accrual after meeting grant enrollment goal, prior to reaching protocol accrual goal, due to end of funding.
United States13 participantsStarted 2013-08
Plain-language summary
This is a single institution, observational research study in which patients are observed using DWI/DCE MRI imaging before and after receiving neoadjuvant anti-HER2 therapy.
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Subjects at least 18 years of age.
* Have a new diagnosis of invasive breast cancer, clinical stage I - III, HER2 positive.
* Planning to undergo surgical resection plus adjuvant therapy to include an anti-HER2 agent.
* Have tissue block available for review of experimental markers.
* Be a candidate for MRI imaging.
* Be willing to comply with scheduled visits required for the trial.
* Ability to understand and the willingness to sign a written informed consent document.
Exclusion Criteria:
* Recent therapy for breast cancer prior to baseline MRI.
* Subjects may not receive other investigational agents during the study window for imaging.
* Contraindications for MRI or MRI contrast including severe claustrophobia, history of previous reaction to MRI contrast, renal disease, congestive heart failure, other significant systemic diseases or any metal in their body, including but not limited to: a brain aneurysm clip, implanted neural stimulator, implanted cardiac pacemaker or defibrillator, cochlear implant, ocular foreign body (e.g. metal shavings), other implanted medical devices: (e.g. Swan Ganz catheter), insulin pump, metal shrapnel or bullet.
* Pregnant or nursing.