No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
Ready to participate?
Review the details below, then apply to join this clinical trial.
At a Glance
Age
18 and older
Sex
Female
Trial phase
Phase 1/2
Study type
Interventional
Purpose
Diagnostic
Participants needed
55 (estimated)
Sponsor
Memorial Sloan Kettering Cancer Center · Other
Who this trial is looking for
This trial is looking for adults with a confirmed diagnosis of breast cancer. Participants will receive advanced imaging before and during surgery to better see and remove tumors.
Are You a Good Fit for This Trial?
You may be able to join if
I am 18 years or older
I have been diagnosed with breast cancer
My tumor is stage Tis, T1, or T2 and larger than 1 cm
I will undergo surgery to conserve breast tissue
I have not received any prior treatment
My performance status is 0, 1, or 2
You may not be able to join if
My life expectancy is less than 3 months
I am pregnant or breastfeeding
I have known liver disease or cirrhosis
I have moderate liver impairment
I am allergic to indocyanine green
I have impaired decision-making capacity
Summarized in plain language from this trial's official eligibility criteria.
The full criteria are further down this page — only the research team can
confirm whether you qualify.
Think this trial could be right for you?
Answer three quick questions written from this study's own rules to see if you may qualify. No account needed to find out.
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 n…
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.
During the Phase IIa part of this study, the safe dose of pHLIP ICG will be used that makes it easy for the surgeon to see the tumor and the nearby tissues and structures that may contain cancer cells. This study is the first to test pHLIP ICG in people, and the first to test the use of pHLIP ICG with mpMRI and NIRF imaging in surgery for breast cancer.
Trial Locations
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Status
Eligibility Criteria
Inclusion Criteria:
* Age 18 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
* ECOG performance of 0-2
Exclusion Criteria:
* Life expectancy \< 3 …
Inclusion Criteria:
* Age 18 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
* ECOG performance of 0-2
Exclusion Criteria:
* Life expectancy \< 3 months
* Pregnancy or lactation
* 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
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