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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.
 
ClinicalTrials.gov Identifier: NCT05130801
Recruitment Status : Recruiting
First Posted : November 23, 2021
Last Update Posted : November 23, 2021
Sponsor:
Collaborators:
Stryker Instruments
pHLIP Inc.
Information provided by (Responsible Party):
Memorial Sloan Kettering Cancer Center

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Diagnostic Test: pHLIP® ICG NIRF imaging Phase 1 Phase 2

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 43 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Diagnostic
Official Title: Phase I/IIa Study of Pre-operative Multiparametric MRI and pHLIP® ICG Intra-operative Fluorescence Imaging of Primary Breast Cancer
Actual Study Start Date : November 19, 2021
Estimated Primary Completion Date : November 2023
Estimated Study Completion Date : November 2023

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
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.
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





Primary Outcome Measures :
  1. 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.



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Ages Eligible for Study:   21 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Gender Based Eligibility:   Yes
Gender Eligibility Description:   Breast Cancer
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05130801


Contacts
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Contact: Katja Pinker-Domenig, MD, PhD 646-888-5470 pinkerdk@mskcc.org
Contact: Monica Morrow, MD 646-888-5350

Locations
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United States, New York
Memorial Sloan Kettering Cancer Center (All Protocol Activities) Recruiting
New York, New York, United States, 10065
Contact: Katja Pinker-Domenig, MD, PhD    646-888-5470      
Sponsors and Collaborators
Memorial Sloan Kettering Cancer Center
Stryker Instruments
pHLIP Inc.
Investigators
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Principal Investigator: Katja Pinker-Domenig, MD, PhD Memorial Sloan Kettering Cancer Center
Additional Information:
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Responsible Party: Memorial Sloan Kettering Cancer Center
ClinicalTrials.gov Identifier: NCT05130801    
Other Study ID Numbers: 21-225
First Posted: November 23, 2021    Key Record Dates
Last Update Posted: November 23, 2021
Last Verified: November 2021
Individual Participant Data (IPD) Sharing Statement:
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 clinicaltrials.gov 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: crdatashare@mskcc.org.

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Memorial Sloan Kettering Cancer Center:
MRI
pHLIP® ICG
Imaging
Tumor stage T1-T2
21-225
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases