A Study of Multiparametric MRI and pHLIP® ICG in Breast Cancer Imaging During Surgery

  • STATUS
    Recruiting
  • End date
    Nov 9, 2023
  • participants needed
    43
  • sponsor
    Memorial Sloan Kettering Cancer Center
Updated on 9 January 2022
mammogram

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.

Details
Condition Breast Cancer
Treatment pHLIP® ICG NIRF imaging
Clinical Study IdentifierNCT05130801
SponsorMemorial Sloan Kettering Cancer Center
Last Modified on9 January 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

Age 21 years or greater
Biopsy proven primary breast malignancy (BI-RADS 6)
Tumor stage 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
Liver function laboratory test results within the normal institutional reference range (AST (Plasma <=37 U/L); ALT (Plasma <=55U/L); Albumin (Plasma 3.8-5.0 g/dL); Bilirubin (total Plasma <=1.2mg/dL); Creatinine (0.6-1.1 mg/dL))

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
Known moderate hepatic impairment (in phase I, and in phase IIa dependent on safety profile established in phase I)
atresia, chronic liver disease (CLD) and cirrhosis
Known hypersensitivity to indocyanine green
Individuals with impaired-decision making capacity
Clear my responses

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If you are confirmed eligible after full screening, you will be required to understand and sign the informed consent if you decide to enroll in the study. Once enrolled you may be asked to make scheduled visits over a period of time.

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Complete your scheduled study participation activities and then you are done. You may receive summary of study results if provided by the sponsor.

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