NCT05130801 · Memorial Sloan Kettering Cancer Center
A Study of Multiparametric MRI and pHLIP® ICG in Breast Cancer Imaging During Surgery
What this study is about
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 I
View original scientific description
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.
Interventions
DIAGNOSTIC_TEST
pHLIP® ICG NIRF imaging
Pre-operative research MRI will be performed 1-3 weeks prior to the surgery. single pHLIP® ICG injection will be administered i.v. by a radiologist on the protocol one day prior to scheduled surgery on the occasion of presurgical localization (12-36 hours prior to the surgery). In Phase I, we propose to investigate 4 different doses: Dose level 1 = 0.04 mg/kg Dose level 2 = 0.075 mg/kg Dose level 3 = 0.15 mg/kg Dose level 4 = 0.30 mg/kg In Phase IIa, the researchers propose to administer selected in Phase I dose of pHLIP® ICG. In Phase IIa, the researchers propose to administer pHLIP® ICG at DL2, DL3 or DL4 at different time points prior to surgery ranging from 12-110 hours, with targeted enrollment of 12 patients. Next, the selected optimal dose and timing will be used with targeted enrollment of 28 patients. The total number of subjects in Phase IIa study is 40.
Primary outcome measures
Dose-limiting toxicity (DLT)
Time frame: 15 days post pHLIP® ICG injection
is defined as a clinically significant adverse event recorded within 3 hours after pHLIP® ICG administration or an abnormal laboratory value assessed as unrelated to disease progression, intercurrent illness, surgery, or concomitant medications, and meets the NCI common terminology criteria that are CTCAE Grade 3 or 4.
Visualization of a lesion with pHLIP® ICG (Phase II)
Time frame: up to 6 months
The visualization of a lesion with pHLIP® ICG NIRF (Likert score is ≥1) will be considered positive for malignancy. No visualization of a lesion or visualization at the background level (Likert score is 0) with pHLIP® ICG NIRF will be considered negative for malignancy.
Who can participate
This study lists these criteria on ClinicalTrials.gov. A study coordinator reviews eligibility during screening — this page does not determine whether you qualify.
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
- 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 hypersensiti
Where
- Montvale, New Jersey
- New York, New York
Collaborators
Stryker Instruments, pHLIP Inc.
Related conditions & keywords
Frequently asked questions
What is a clinical trial?
A clinical trial is a research study that tests new medical treatments, drugs, devices, or procedures to determine their safety and effectiveness. Trials are carefully designed and monitored to protect participants while advancing medical knowledge.
Is it safe to participate?
Clinical trials follow strict safety guidelines and ethical standards. Trials must be reviewed and approved, and participants are closely monitored by medical professionals throughout the study. You can withdraw at any time if you choose.
Will I be compensated?
Many clinical trials offer compensation for your time, travel expenses, and inconvenience. The specific compensation varies by study and will be discussed during the screening process. All study-related medical care is typically provided at no cost to participants.
Will I receive a placebo instead of treatment?
When effective treatment exists, participants typically receive either the standard treatment plus the study intervention, or the standard treatment plus placebo. You would not be denied effective care. Placebos are primarily used when no proven treatment is available, or in addition to standard care. Your trial consent form will clearly explain what treatments you may receive.
Can I leave a trial if I change my mind?
Absolutely. Participation in clinical trials is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty or loss of benefits to which you are otherwise entitled.
How long does a clinical trial last?
Trial duration varies widely depending on the study design and purpose. Some trials last just a few weeks, while others may continue for months or years. The study coordinator will provide specific timeline information during your screening call.
Data: ClinicalTrials.gov · synced Apr 22, 2026 · Source of record for eligibility and locations