Breast Cancer Clinical Trial
A Study of Multiparametric MRI and pHLIP® ICG in Breast Cancer Imaging During Surgery
Summary
The purpose of this study is to find out whether pre-operative mpMRI using additional MRI sequences may improve surgical outcomes by providing more accurate information about the extent and acidity of the tumor than standard MRI, and to see whether the use of the fluorescent imaging agent pHLIP ICG and NIRF imaging during surgery is a safe approach that may allow the surgeon to see the tumor and nearby tissues that contain cancer cells more clearly and remove them completely.
Eligibility Criteria
Inclusion Criteria:
Age 21 years or greater
Biopsy proven primary breast malignancy (BI-RADS 6)
Tumor stage Tis, T1 and T2, lesion size > 1 cm
Primary surgical treatment with breast conservation
No previous treatment
No contraindications for MRI or MRI contrast agents or high-field MRI (3T)
ECOG performance of 0-2
Exclusion Criteria:
Life expectancy < 3 months
Pregnancy or lactation
Known contrast agent allergies that require premedication before MRI.
Patients who cannot undergo multiparametric MRI scanning because of:
Weight limits. MRI scanners may not be able to function with patients over 450 pounds.
Severe claustrophobia/ examination associated anxiety.
MRI unsafe implant
Known metastatic liver disease, hepatic neoplasms (benign and malignant), biliary atresia, chronic liver disease (CLD) and cirrhosis.
Known moderate hepatic impairment (in phase I, and in phase IIa dependent on safety profile established in phase I)
Known hypersensitivity to indocyanine green.
Individuals with impaired-decision making capacity
Check Your Eligibility
Let’s see if you might be eligible for this study.
What is your age and gender ?
There is 1 Location for this study
New York New York, 10065, United States More Info
How clear is this clinincal trial information?