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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details. Identifier: NCT05130801
Recruitment Status : Recruiting
First Posted : November 23, 2021
Last Update Posted : December 27, 2021
Stryker Instruments
pHLIP Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

Tracking Information
First Submitted Date  ICMJE November 22, 2021
First Posted Date  ICMJE November 23, 2021
Last Update Posted Date December 27, 2021
Actual Study Start Date  ICMJE November 19, 2021
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: November 22, 2021)
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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
Descriptive Information
Brief Title  ICMJE A Study of Multiparametric MRI and pHLIP® ICG in Breast Cancer Imaging During Surgery
Official Title  ICMJE Phase I/IIa Study of Pre-operative Multiparametric MRI and pHLIP® ICG Intra-operative Fluorescence Imaging of Primary Breast Cancer
Brief 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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Condition  ICMJE Breast Cancer
Intervention  ICMJE 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

Study Arms  ICMJE Experimental: MRI and pHLIP® ICG
All study participants in Phase I will receive pre-operative MRI and mpMRI scans, a pre-operative injection of pHLIP ICG, and NIRF imaging during surgery (intra-operatively). During phase IIa of the study, if pHLIP® ICG NIRF imaging indicates tumor in areas outside of the planned resection area, biopsy samples will be taken from these areas and submitted for pathological analysis.
Intervention: Diagnostic Test: pHLIP® ICG NIRF imaging
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by Identifier (NCT Number) in Medline.
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: November 22, 2021)
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE November 2023
Estimated Primary Completion Date November 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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 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
Sex/Gender  ICMJE
Sexes Eligible for Study: Female
Gender Based Eligibility: Yes
Gender Eligibility Description: Breast Cancer
Ages  ICMJE 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Katja Pinker-Domenig, MD, PhD 646-888-5470
Contact: Monica Morrow, MD 646-888-5350
Listed Location Countries  ICMJE United States
Removed Location Countries  
Administrative Information
NCT Number  ICMJE NCT05130801
Other Study ID Numbers  ICMJE 21-225
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE
Plan to Share IPD: Yes
Plan Description: Memorial Sloan Kettering Cancer Center supports the international committee of medical journal editors (ICMJE) and the ethical obligation of responsible sharing of data from clinical trials. The protocol summary, a statistical summary, and informed consent form will be made available on when required as a condition of Federal awards, other agreements supporting the research and/or as otherwise required. Requests for deidentified individual participant data can be made beginning 12 months after publication and for up to 36 months post publication. Deidentified individual participant data reported in the manuscript will be shared under the terms of a Data Use Agreement and may only be used for approved proposals. Requests may be made to:
Responsible Party Memorial Sloan Kettering Cancer Center
Study Sponsor  ICMJE Memorial Sloan Kettering Cancer Center
Collaborators  ICMJE
  • Stryker Instruments
  • pHLIP Inc.
Investigators  ICMJE
Principal Investigator: Katja Pinker-Domenig, MD, PhD Memorial Sloan Kettering Cancer Center
PRS Account Memorial Sloan Kettering Cancer Center
Verification Date December 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP